The Micronclean

Cleanroom Handbook
Written by Neil Clayton Tim Eaton

A Micronclean Limited Publication UK 2011.

Published by Micronclean Limited.
Copyright © 2011 Micronclean Limited.
All rights reserved.

ISBN 978-0-9570735-0-0

Printed and bound in the UK.

Introduction

The first Micronclean Handbook was published in Much of the information provided in this book is
1981 and was revised and re-issued ten years later as therefore based on practical experience gained in
the ‘New Micronclean Handbook to Good Cleanroom operating our own cleanrooms and in supplying
Clothing Practice’. Over 10,000 copies have been services to a wide range of industries throughout the
distributed internationally. world, each with their own specific contamination
control requirements and challenges.
The ‘Micronclean Big Blue Cleanroom Handbook’ is
the latest edition and has been completely re-written The ‘Micronclean Big Blue Cleanroom Handbook’ is
to provide an up-to-date resource for anyone involved divided into self-contained sections which provide the
with any aspect of contamination control systems and reader with readily available and practical information
controlled environments. on specific topics. It is hoped that this will be of benefit
in helping to address the technical and financial
It is produced by Micronclean - a group of companies problems routinely posed by complex contamination
operating internationally that in the early stages of control requirements.
cleanroom technology pioneered the development of
contamination control clothing and cleanroom garment We would welcome any comments and can be
decontamination and that has since expanded to contacted by email at: [email protected]
provide a wide range of contamination control products
and services.

About the authors

Neil Clayton trained as a Biomedical Scientist and
worked in Medical Microbiology for 10 years before
moving to Science Education. He has worked for
Micronclean since 1991 in a variety of Technical,
Commercial and Training roles.

Tim Eaton is the Sterile Manufacturing Specialist for

AstraZeneca UK Operations. He has 20 years experience
with sterile products, cleanroom technology and aseptic
manufacturing.

We would also like to thank Micronclean staff for their

help, comments and suggestions during the writing of
The Big Blue Cleanroom Handbook.

1
Contents
Section Title Page

1.0 The Cleanroom Environment 4

1.1 A Brief History of Cleanroom Development 4
1.2 Cleanroom Design and Construction 6
1.3 Materials, Fixtures, Fittings and Construction - Points to Consider 10
1.4 Barrier Isolators, Laminar Airflow Cabinets and Biological Safety Cabinets 12

2.0 Cleanroom Classifications & Standards 14

2.1 Cleanroom Particulate Standards and Classifications 14
2.2 Cleanroom Microbiological Classifications and Standards 17
2.3 ESD Requirements and Standards 18
2.4 IEST-RP-CC003 19
2.5 ASTM F51/00 20
2.6 BS EN 14065:2002 Textiles - Laundry Processed Textiles -
Biocontamination Control System 21

3.0 Contamination Control & Staff 22

3.1 The Effect of Staff 22
3.2 Entry and Exit Procedures 25
3.3 Changing Areas 26
3.4 Gowning Techniques and Changing Procedures 28
3.5 Training Requirements 30
3.6 Garment Systems and Changing Frequency 30

4.0 Reusable Contamination Control Clothing 33

4.1 Reusable Cleanroom Clothing - the Three Principal Requirements 33
4.2 Cleanroom Fabrics 34
4.3 Cleanroom Clothing Design and Construction 38
4.4 Cleanroom Clothing Fixtures and Fittings 39
4.5 Special Cleanroom Garment and Fabric Requirements 39
4.6 Fabric Test Methods 41
4.7 Body Box Test 42
4.8 Cleanroom Undergarments 45

5.0 Disposable Contamination Control Clothing 46

5.1 Disposable Clothing 46
5.2 Bodywear 48
5.3 Headwear 51
5.4 Handwear 54
5.5 Footwear 59

6.0 Decontamination of Cleanroom Garments & Consumables 61

6.1 Purpose and Function 61
6.2 Cleanroom Garment and Consumables Decontamination Plant -
Layout and Contamination Control Requirements 63
6.3 Cleanroom Decontamination Plant Cleaning Process 69
6.4 Disinfection and Sterilisation 69
6.5 Particulate and Fibre Decontamination 73
6.6 Product Inspection and Conformance Checks 75
6.7 Labelling, Packaging and Presentation 76
6.8 Process Monitoring, Controls and Records 78
6.9 Cleanroom Decontamination Plant Audits 80
6.10 Special Customer Requirements 80

2
Section Title Page

7.0 Cleanroom Cleaning - Methods and Equipment 82

7.1 Contamination Control and the Requirement for Cleaning 82
7.2 Cleanroom Cleaning - General Considerations 83
7.3 Cleaning Plans, SOPs and Records 87
7.4 Vacuum Systems 88
7.5 Mops 89
7.6 Wipes and Swabs 91
7.7 Chemicals for Cleaning and Disinfection 96
7.8 Contamination Control Flooring and Mats 98
7.9 Confirming Effective Cleaning 99

8.0 Planning, Sourcing and Optimising Cleanroom Clothing Supply 100

8.1 Planning the Process 100
8.2 Selecting a Cleanroom Clothing Project Team 101
8.3 New Cleanroom Clothing system or Review of Existing Supply Arrangements 101
8.4 The Budget 102
8.5 Timescales 102
8.6 Fabric and Garment Style Selection Process 102
8.7 Determining the Numbers of Garments Required 104
8.8 Cleanroom Clothing Distribution Systems 107
8.9 Supply Options and Supplier Selection 109
8.10 Implementation and Maintenance of the Clothing System 111

9.0 Planning, Sourcing and Optimising Cleanroom Consumables Supply 112

10.0 Acknowledgements, References, Useful Contacts and Sources of Information 119

3
 SECTION

1.0
The Cleanroom Environment

1.1
A Brief History of Cleanroom Development
The increasing complexity and precision of some The development of controlled production
manufactured products has led to the requirement environments into the modern cleanroom concept was
for contamination control techniques and associated accelerated by the space race in the 1960s.
systems.

The potential for damage to complex products by

environmental contaminants, introduced during
manufacture, was first identified as a significant problem
during the Second World War. It was realised that the
cleanliness of the manufacturing environment had to
be improved to prevent damage to and malfunction of
precision products such as airplane bombsights.

Development of nuclear, chemical and biological

weapons also required the control of very small
particles and the High Efficiency Particulate Air filter
(HEPA filter) was developed to meet this need.

The HEPA filter was fundamental to the first industrial

cleanrooms which were constructed in the 1950s,
supplying clean air to the manufacturing areas and
achieving low airborne contamination levels for the
The photograph shows the first Horizontal Laminar Flow Bench
manufacture of precision components such as missile owned by the United States Air Force (Circa 1962). Dr Philip
gyroscopes. These early types of cleanroom were non- R. Austin is seen carrying out experiments to determine how
unidirectional airflow (or turbulent airflow) cleanrooms. cleanroom clothing affected operations within the workbench.
Photograph reproduced with the kind permission of Dr. Philip R.
Austin.

Rocket engines were found to have failed when liquid

oxygen release valves jammed due to contamination by
microscopic dust particles during assembly and space
project-engineers are credited with the development of
unidirectional airflow cleanrooms (often referred to as
laminar airflow) as a solution to this major problem.

This new approach to contamination control provided

an airborne cleanliness level that was over 1000
times cleaner than that achievable with the earlier non-
Early cleanroom manufacturing
unidirectional airflow cleanroom and continues to provide
a major method of contamination control to this day.

4
The rapid global development of microelectronics Cleanroom manufactured
space and communication
and ever decreasing circuit geometry has led to the products
introduction of very large cleanroom manufacturing
sites with emphasis on the control of sub-micron size
particulate, electrostatic and chemical contaminants.

Developments in modern health-care products have

led to the global use of very closely-controlled and
regulated Pharmaceutical and Biomedical cleanroom
manufacturing facilities.

Health-care cleanrooms not only provide control of

environmental particulates and fibres but also have
additional emphasis on the monitoring and control of
microbiological contamination.

These types of facilities have incorporated the aseptic

techniques and sterilisation processes, developed since
the early 1900s within hospital operating theatres, into
industrial cleanrooms. Cleanroom manufactured microelectronic products.
Picture reproduced by kind permission of Photronics UK Ltd.

Standard procedures include the use of protective

garments for personnel and the sterilisation of critical
components prior to transfer into the cleanroom areas.
Specialised working techniques and manipulations,
such as avoiding working directly above any cleanroom
products, became the established operational
procedures.

Cleanrooms are now widely used throughout the

modern world for the manufacture of a vast range
of products, such as electronics and semiconductor
devices, nanotechnology products, medicines, medical
devices, paint and surface finishes, optical devices, food
and drinks.

Cleanroom manufactured medical products

Throughout the period of cleanroom development

various National and International Standards,
Guidelines, Test Methods and Recommended Practices
have been introduced and subsequently updated
and these are discussed in Section 2.0 Cleanroom
Cleanroom manufactured industrial products Classifications and Standards.

5
1.2
Cleanroom Design and Construction
A cleanroom is designed, constructed and maintained
to provide a production environment which minimises
the potential for damaging contamination of product.
The type of product and the degree of control required
to protect the product are therefore the most critical
factors in determining cleanroom specifications.
In general, simple room shapes allow for the most
effective airflow patterns and facilitate effective
cleaning and so to meet these requirements, most
cleanrooms are box-shaped without overhanging
obstructions.

A cleanroom works by controlling the introduction

and entry of particles into the room and also controls
the generation and retention of particles within the
room. High volumes of filtered air are supplied to the
cleanroom to dilute and remove contamination and to
pressurise it to prevent the entry of less clean air from
adjacent dirtier areas. The cleanroom is constructed
with materials that do not themselves generate particles Airborne particles

and can be readily cleaned to remove deposited

contamination. Personnel who enter the cleanroom Airborne particulate matter is composed of two distinct
are a great source of particle contamination and are types:
required to wear appropriate cleanroom clothing to a) Inert particles and fibres which can be damaging to
minimise this risk. (The effect of people and the use of products either physically or chemically.
contamination control clothing are discussed in detail b) Micro-organisms, also know as viable particles.
in Sections 3.0 Contamination Control and Staff and 4.0
Reusable Contamination Control Clothing.) Micro-organisms not only compromise product by
physical and chemical damage but also present a
Control of environmental factors such as temperature unique threat to biomedical products by their ability
and relative humidity may also be required. to grow and multiply. This may lead to products being
contaminated by harmful exotoxins and endotoxins,
Non-filtered air varies greatly from location to location such as pyrogens, which can remain active even if the
and also varies over the course of time. viable micro-organisms are destroyed.

This occurs because a vast quantity of particulate matter, Particles of concern to precision manufacturing
from many sources and of varying sizes, is generated facilities usually range in size from approximately 50
by natural events and human activity and most of these micrometres (microns) down to sub micron ‘superfine’
particles are invisible to the unaided eye. particles and HEPA filters and ULPA filters (Ultra Low
Particulate Air filter) are used as the principle control
Collectively, airborne particulate material is often method of these airborne contaminants.
referred to as ‘dust’ and as microscopic particles remain
suspended in air, or fall only slowly under gravity, they
can travel great distances.

6
 High efficiency air filter
The number and type of filters used will therefore be a
critical factor in the cleanroom design and an increase
in air filtration will produce a reduction in airborne
particulate.
Put simply; More filtration = Less contamination

Contaminated input air

Production
Pre-filter Equipment

Air extract Air extract

HEPA depth filter

Non-directional or turbulent airflow cleanroom

In many facilities however more stringent control is

required and unidirectional airflow is used.
Aluminium frame

Decontaminated output air

Unidirectional Airflow
Unidirectional (or laminar) airflow is achieved by
Diagram of HEPA Filter
constructing the room so that the air supply is from a
complete coverage of HEPA filters. Air from the filters
Airflow passes through the room in a continuous one-way
The rate of airflow through the filters and through airstream at a uniform velocity.
the cleanroom is also a significant factor in removing
particles generated within the room with a greater Recirculated air Return air plenum Recirculated air
number of air changes producing higher cleanliness
High
levels and so this too is determined by the degree of efficiency
filters

contamination control required.

Non-unidirectional or Turbulent Airflow

Non-unidirectional airflow cleanrooms work by mixing
and diluting the contamination generated within the
cleanroom with filtered supply air.

The filtered air is normally supplied at ceiling level and

extracted via ducts at low level located around the Production
Equipment

cleanroom, or it may simply escape through the door

gaps to the adjacent areas. In general, the higher the
Air extract Air extract
rate of supply air and the better the mixing within the
cleanroom, the higher the attained airborne cleanliness Unidirectional airflow cleanroom
levels. The number of room air change rates per hour
(ACH) is often measured to provide some information
relating to the airborne cleanliness levels. This type
of cleanroom provides a basic level of contamination
control suitable for a number of less critical activities
such as the manufacture of pneumatic equipment,
optical components, basic wound dressings, or circuit
assembly.

7
This airflow provides a ‘piston’ of air that flows down
through the room, effectively removing particulate
material generated within the area through room extract
vents and by re-circulation through the filters via return
air plenums incorporated into the cleanroom structure.
Air re-circulated in this way typically makes up around
80% of air within the room with the remainder being
made up of fresh air.

Unidirectional flow gives a continuous purging effect

which can be improved by increasing the velocity of
airflow; often measured as the number of air changes Horizontal unidirectional airflow cleanroom
per hour (ACH) in the cleanroom. In general, the higher
the airflow velocity, the better the airborne operational
cleanliness levels.

Unidirectional airflow is most commonly arranged to

pass from ceiling mounted filters to floor-level return-
air plenums and the most effective flow is achieved by
incorporating a perforated floor providing unidirectional
flow right through the full height of the cleanroom. This
configuration is referred to as vertical unidirectional
airflow and contaminants being liberated into the room
are purged downwards and out by this flow.
Vertical unidirectional airflow cleanroom
For some production processes however it is preferable
to have airflow which purges the cleanroom horizontally
Product and People Flow
and this is achieved by wall-mounting the filters and
When contemplating design of a new cleanroom or
siting the return air ducts in the opposite wall.
modification to existing facilities, product flow and
This airflow across the room produces a horizontal
people flow are of major importance.
unidirectional airflow cleanroom.
Many products will require multiple components and
Unidirectional airflow cleanrooms are used for the
process stages and the workflow should provide the
manufacture of products requiring the highest level of
most efficient production route whilst ensuring that
contamination control such as injectable medicines and
the different production stages are carried out with
integrated circuits.
appropriate levels of contamination control.
This will often mean considering the removal
of component packaging or containers, primary
preparation stages, final manufacture or assembly,
primary packaging, labelling and final packaging.

8
 For any grade of cleanroom best practice advocates a The number and type of changing rooms required will
single process flow of product, with entry at one end be a critical factor in cleanroom design with several
and exit of finished product from the opposite end of consecutive changing rooms, each at an increased
the facility. This helps to manage the various stages level of contamination control, providing the highest
of the process and to control component segregation standard.
and the risk of cross contamination. Separate entrances
to segregate personnel from components are For a high grade cleanroom manufacturing operation,
recommended with separate exits for finished product. personnel entry into the cleanroom area would typically
utilise a two or three stage entry system.
Staff numbers and activities must be carefully
considered as they will have the most significant effect The first stage would be to change from normal
on the in-use cleanroom contamination levels and the clothing into dedicated plant attire. Further entry into
people effects are discussed in more detail in Sections the cleanroom area would involve the application
3.0 Contamination Control and Staff and 4.0 Reusable of specialist cleanroom garments which have
Contamination Control Clothing. been decontaminated by a cleanroom garment
decontamination plant and may also have been
sterilised.

Raw materials Primary Final processing

preparation processing high grade
area low grade cleanroom
cleanroom Staff changing
and access

Transfer hatch Transfer hatch

Raw
materials

Staff changing
and access

Staff changing
and access

Transfer
hatch

Red arrows denote product flow Finished product

for despatch
Yellow arrows denote personnel flow

Diagram showing product and personnel flow in a typical cleanroom manufacturing process.

9
1.3
Materials, Fixtures, Fittings and Construction - Points to Consider
Selection of cleanroom construction and materials will
depend on the level and type of contamination control
required, speed of construction, lifespan and cost.

Cleanroom areas can be quickly and inexpensively

constructed using various systems such as PVC strip
curtains, softwall enclosures or portable structures.
Modular rooms can be constructed within existing
structures or complete design and build can be
undertaken.

For any cleanroom where control of microbiological

contamination is the main requirement all materials of
construction and cleanroom surfaces must be smooth,
impervious, non shedding, durable and laid to an even Cleanroom wall and ceiling interfaces with coved and
rounded corners
surface. Surfaces need to be readily cleanable, resistant
to cleanroom disinfectants and not contribute any
cleanroom contamination. All joints must be airtight and Floors that are subject to wetting may need to have a
well sealed and horizontal surfaces should be avoided slip-resistant finish and other areas that are subject to
to reduce the accumulation of contamination. heavy equipment and abrasion may require especially
durable materials.
As angular corners are difficult to clean effectively the
interface of the floors, walls and ceilings needs careful If ESD (electro-static discharge) control is important
consideration and the use of coved and rounded then materials must be used which will facilitate this
corners is usual. requirement. This may require electrically conductive
materials and fittings such as earthing points and
Cleanroom Wall and Ceiling Interfaces conductive flooring together with additional equipment
Common materials of construction for walls, floors and such as ceiling mounted de-ionisers.
ceilings include sheet vinyl, epoxy screed, terrazzo
(epoxy resin binder) epoxy paint on plaster, glass Communication to personnel within the cleanroom is an
reinforced plastic, plastic-coated metal, stainless steel, essential requirement. Any intercom system should be
powder coated steel with suitable enamelled paint of hygienic design, flush-mounted and easily cleanable.
and other synthetic materials such as ‘Trespa’, and Window-mounted speech panels are also used but
‘Melamine’. conventional telephones should be avoided in high
grade areas as they are difficult to clean and require
significant handling,

Where possible cleanroom windows should be non-

opening, flush-fitting and double-glazed and any sills
need to be steeply sloped. The windows need to be
pressure tested to withstand the room differential
pressures and should provide good visual access to
permit supervision and observation of cleanroom
activities.

10
 Cleanroom lighting should be flush fitting with the
ceiling to aid cleaning and be fitted to permit the
changing of defective tubes from above the cleanroom,
thus preventing unnecessary cleanroom maintenance
activities.

Cleanroom window with rounded corners

Hatches and entrance doors are an important

mechanism for the transfer into the cleanroom of
staff, consumables and components and for the exit of Cleanroom plant room
finished product and waste.
Wherever possible, plant rooms should not be included
into the cleanroom but accommodated in an adjacent
Doors should not be opened simultaneously and should
area and the services piped in or supplied accordingly.
be controlled by an interlock system with visual and or
This minimises cleanroom disruption and enables easy
audible alarms to alert personnel of loss of pressure or
access for maintenance activities.
the simultaneous opening of both sets of doors.
Furniture and equipment provided must also meet
Drains and sinks are normally excluded from aseptic
contamination control requirements and stainless steel
cleanroom areas due to their high risk of contamination
is often used to manufacture these items.
from water borne organisms.

Open drains should not be used in cleanroom areas

where water is required. If drains are fitted to equipment
such as washing or cleaning units air breaks are utilised
between the outlet pipe and the drain to prevent back
siphoning of soiled water.

Services
Where possible, all services should be run outside the
cleanroom with minimal equipment or pipework inside
the cleanroom. This reduces cleaning problems and
allows maintenance activities to be completed without
entering the cleanroom. Stainless steel cleanroom equipment

It is bad practice to run water and steam pipes directly

above the cleanroom in case they develop leaks that
can then seep into the cleanroom below. Welded pipe
joints are more hygienic and the preferred choice,
especially for water systems.

11
 Stainless steel cleanroom equipment
Image courtesy of Medical & Scientific Structures
Cleanroom barrier isolator. Image courtesy of Bioquell UK Ltd

Barrier isolators (also called a unidirectional airflow

Any non-shedding materials may be used however as workstation) provide a controlled environment with
long as they are not producing or harbouring particulate work occurring inside a closed, pressurised cabinet
contaminants and can be easily cleaned. accessible only via sealed gloves that reach into the
work area.
For safety and compliance monitoring continuous
particle monitoring systems may be required for high It is common to find a low-grade unidirectional or non
grade cleanrooms together with the use of CCTV. unidirectional airflow cleanroom in which there is also
a unidirectional airflow workstation. The workstation
Health and Safety issues must also be addressed provides a working zone of high environmental control,
and especially the provision for fire detection and or ‘critical’ area where open product or components are
emergency exits for cleanroom staff. manipulated or processed. The lower grade controlled
background environment helps to minimise the transfer
Specialist cleanroom construction and equipment of contamination into the critical area.
companies provide a valuable source of information and
services to suit all applications and requirements. Many different types of Isolator are produced with
different configurations of docking device which allow
components, materials and products to be transferred in
1.4
and out of the Isolator.
Barrier Isolators, Laminar Airflow Cabinets and
Biological Safety Cabinets Isolators are frequently used for aseptic compounding
Barrier Isolator of drug products and can often be internally sterilised
A barrier isolator is an enclosed space supplied with e.g. using hydrogen peroxide vapour.
filtered air which provides effective isolation of its
interior from the surrounding environment.

This means that by installing a barrier isolator,

cleanroom conditions can be obtained within a
contained workspace.

12
 High efficiency air filter
Laminar flow enclosures can also be made to any
HEPA Filter
size and are commonly used to provide increased
contamination control zones over local areas of large
automated operations e.g. the aseptic filling zone for
ampoule manufacture.

Biological Safety Cabinets

Biological safety cabinets are used to provide primary
containment when using potentially infectious or
Barrier
Isolator harmful materials e.g. cytotoxic drugs. There are three
types.
Air extract Air extract

Class I
Barrier isolator inside a low grade cleanroom An open-front negative pressure cabinet where the
exhaust air from the cabinet is filtered by HEPA filter.
Laminar Airflow Cabinet
Laminar air flow cabinets (often called LAF or clean Class II
benches) are designed to create a particle-free working An open-fronted ventilated cabinet with a HEPA-filtered,
environment usually within a classified cleanroom. recirculated airflow within the work space. The exhaust
air from the cabinet is also HEPA filtered.
Air is taken through a filtration system comprised of
a pre-filter and one or more HEPA filters and then Class III
exhausted across a work surface in a laminar or A totally enclosed ventilated cabinet of gas-tight
unidirectional air stream. construction. Operations within the Class III cabinet are
conducted through attached rubber gloves.
The laminar flow cabinet creates a very clean zone
for many manufacturing operations in the medical, Supply air is drawn into the cabinet through HEPA filters
electronic and industrial sectors. and the exhaust air is passed through two HEPA filters
before discharge outside of the production area.

Laminar airflow cabinet

13
 SECTION

2.0
Cleanroom Classifications & Standards

2.1
Cleanroom Particulate Standards and Classifications
A Brief History Particle counters were installed in the USAF cleanrooms
As cleanroom technology was established it became all over the world and subsequently the particle size
necessary for standards to be produced which would distributions were determined from hundreds of
enable users to specify and monitor the levels samplings within the cleanrooms.
of contamination control required for particular
manufacturing operations.

Introduction of standards allowed manufacturers to

understand the effects of different cleanliness levels
on product contamination and this in turn led to the
development of new and improved cleanroom systems.
The use of clear standards also allowed customers for
cleanroom products to agree and confirm conditions of
product manufacture and provided assurance on the
levels of contamination control maintained throughout
the production process.

The first cleanroom standard was US Air Force Technical Electronic particle counter
Order 00-25-203 which was written in 1961. The
USAF built many cleanrooms throughout the world and
High values and low values were recorded and the data
initially air sampling was achieved using membrane
was averaged and used in TO 00-25-203 to specify
filters which were then read under a microscope and
USAF cleanroom airborne cleanliness conditions for
recorded as particles at the 5μm particle size.
particles 0.5μm/ft3 at class 1,000 and class 10,000.
Laminar (unidirectional) airflow benches and
Royco instruments, working with the Armour
cleanrooms were then developed and USAF class 100
Foundation, then produced the first vacuum tube
was additionally defined and included in the standard.
particle counter, using a white light source, with channel
Word of TO 00-25-203 spread and industry started
sizes ranging from 0.3μm to 10μm. The wavelength
specifying cleanrooms for civilian applications.
of white light is in the range 0.3μm to 0.4μm and so
Eventually TO 00-25-203 was moulded into a new
particle counts at this size were not very accurate and
document - Federal Standard 209ref1 which was
because of this limitation 0.5μm was chosen as the
published in 1963.
smallest reliable channel. These two particle threshold
limits are stated in a number of current cleanroom
As cleanroom technology came to be used
standards, particularly those associated with healthcare
internationally countries throughout the world also
activities.
produced their own National standards and these
included British Standard 5295ref2 in the UK.

14
Particulate Classifications
Airborne cleanliness levels are determined by counting
the number of particles, at a defined threshold diameter,
in a determined volume. The unit of measure of such
particles is the micrometre (μm) or micron and 1 μm is
a millionth (1 x 10-6) of a metre. Typically, the smallest
visible particle on a surface is approximately 50μm
in diameter, fog particles are 10μm in diameter and a
human hair has a diameter of approximately 100μm.

Relative particle sizes

Federal Standard 209

The first available and most readily understood standard was Federal Standard 209 (1963) which recorded
cleanliness levels by considering the number of particles ≥0.5 µm per ft3. This simple classification system, with
some appropriate types of cleanroom operations, is shown below.

Federal Standard 209 (1963) Cleanroom Classification System

FS209 (1963) 1 10 100 1000 10000 100000

Classification

No. of Particles/ft3 1 10 100 1000 10000 100000

≥0.5μm

Cleanroom Integrated Semi Injectable High quality High grade General

Manufacturing Circuit conductor medicines optical gearing, optical work,
Operations equipment, precision assembly of
Gyroscopes pneumatic electronic
equipment equipment

Several changes to FS 209 were made over the With the rapid increase in the global use of cleanrooms
years and the final version FS209E, utilised metric for the production of pharmaceutical products and
nomenclature i.e. particles per m3 (1 m3 = 35.2 ft3). microelectronic devices the requirement for an
Consequently, 100 particles per ft3 became 3520 agreed international standard became apparent and
particles per m3. International Standard ISO 14644ref 3 was developed.

15
ISO 14644 contains nine separate parts with ISO14644- The whole standard provides a comprehensive source
1 published in 1999 followed by ISO 14644-2 in 2000. of information and specifications for all aspects of
The issue of the first two parts enabled National cleanroom design, construction, classification, operation
standards to be replaced with the new International and monitoring.
standard and Federal Standard 209E was withdrawn in
November 2001. ISO 14644 allows the user to specify the particle size to
be counted and to calculate the ISO classification from
The nine separate parts of ISO 14644 are shown below the number of particles measured.

ISO 14644-1: Classification of air cleanliness

This differs in its approach from the original National
ISO 14644-2: Specifications for testing and standards which specified specific particles sizes to be
monitoring to prove continued counted.
compliance with ISO 14644-1
ISO 14644-3: Test Methods The standard also requires the ISO classification to
ISO 14644-4: Design, Construction, and Start-up be described as ‘at rest’ or ‘in use’ to differentiate
ISO 14644-5: Operations between the performance of the room as built and the
contamination levels which exist whilst manufacturing
ISO 14644-6: Vocabulary
operations are taking place.
ISO 14644-7: Separative devices (clean air hoods,
gloveboxes, isolators and mini Using ISO 14644-1cleanrooms are classified as ISO
environments Class 1 to ISO Class 9.
ISO 14644-8: Classification of airborne
molecular contamination
ISO 14644-9: Classification of surface
particle cleanliness

ISO 14644-1 airborne particulate classes for cleanrooms and clean zones at the particle sizes given

ISO Classification Maximum concentration limits (particles/m3 of air) for particles

Number equal to and larger than the considered sizes shown below
0.1μm 0.2μm 0.3μm 0.5μm 1μm 5μm
ISO 1 10 2
ISO 2 100 24 10 4
ISO 3 1,000 237 102 35 8
ISO 4 10,000 2,370 1,020 352 83
ISO 5 100,000 23,700 10,200 3,520 832 29
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO 7 352,000 83,200 2,930
ISO 8 3,520,000 832,000 29,300
ISO 9 35,200,000 8,320,000 293,000

16
The ISO Cleanroom Classification number compared to the Federal Standard 209 and British Standard 5295 (both
now deleted) is shown below.

Table showing relationship between cleanroom standards

ISO Classification
US FED 209E (D) BS 5295
Number
ISO 1
ISO 2
ISO 3 M1.5 (1) ‘C’
ISO 4 M2.5 (10) ‘D’
ISO 5 M3.5 (100) ‘E’ or ‘F’
ISO 6 M4.5 (1,000) ‘G’ or ‘H’
ISO 7 M5.5 (10,000) ‘J’
ISO 8 M6.5 (100,000) ‘K’
ISO 9

2.2
Cleanroom Microbiological Classifications and Standards
A Brief History
Early cleanroom development was concerned with
the control of all contaminating particles and no
differentiation was made between inert, non-living
particles and viable particles such as bacteria and fungi
and this was the basis of all cleanroom standards. This
approach is completely appropriate for the manufacture
of non-medicinal products as product damage is caused
purely by the physical presence of a particle.

The use of cleanroom technology was rapidly adopted

however as an excellent environment for the production
of medicinal and other bio-medical products. These
products are used within living systems and so are
Magnified image of bacterial cells
especially vulnerable to contamination by the inclusion
of viable particles (micro-organisms).
The MHRA (Medicines and Healthcare products
In Pharmaceutical manufacture contamination control Regulatory Agency) Rules and Guidance for
technologies were found to be especially beneficial in Pharmaceutical Manufacturers and Distributors ref 4
the production of medicinal products which cannot be This important publication is also know as “the Orange
sterilised after production, requiring aseptic techniques Guide” and was first published in 1971. It provides
to produce safe, contamination-free products. information on the pharmaceutical regulations,
directives and guidance for the manufacture and
In order to estimate the levels of viable particles distribution of medicinal products in the European
present and to establish the control levels required, Union. Part of the guide deals with the classification
microbiological monitoring systems were introduced of different manufacturing environments and assigns
into these manufacturing areas. grades A, B, C, D.

17
These classifications combine a particulate standard,
based on particulate sizes of ≥0.5 µm and ≥5µm
and recommended microbiological limits. The
microbiological limits are based on active air sampling,
settle plate, contact plate and operator glove print test
methods.

The table below shows the ‘Orange guide’ GMP Grades

and limits for microbiological contamination.

MHRA recommended limits for microbial contamination (a)

Grade air sample cfu/m3 settle plate (diam. contact plate (diam. glove print 5 fingers
90mm) cfu/4 hours (b) 55mm) cfu/plate cfu/glove
A <1 <1 <1 <1
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -
Notes: (a) These are average values Table reprinted with the permission of MHRA.
(b) Individual settle plates may be exposed for less than 4 hours.
cfu = colony forming unit
2.3
The US aseptic processing guide is a further
ESD Requirements and Standards
source of information.
Control of electro-static discharge (ESD) is critical in any
manufacturing area where products may be damaged
ISO 14698 ref 5 - Cleanrooms and associated controlled by static discharge or where a fire risk is present. High-
environments - Biocontamination control grade surface finishing operations may also require ESD
This International standard was published in 2003 and control.
is in 2 parts:
Part 1 General principles and methods. Fabrication of electronic devices and the assembly of
Part 2 Evaluation and interpretation of data. medical devices are the main cleanroom manufacturing
operations which most often consider this hazard.
ISO 14698 does not suggest specific microbiological
levels associated with cleanroom classifications
but instead gives comprehensive information on
establishing and maintaining a rigorous and meaningful
microbiological test programme.

Recording and interpretation of results, the setting of

action, alert and target levels and trending of data for
assessment are also discussed in detail.

ESD controlled area

18
BS EN 61340 ref 6 - Protection of electronic devices from The RP gives details of the Helmke drum test which
electrostatic phenomena, gives details of how to create may be used to determine the particle emission rate
an ESD protected area of manufacture (EPA). It contains from cleanroom clothing and as such can be used
guidance on the requirements for anti-static clothing as a process measure for garments which have been
including garments for cleanroom use. processed by a cleanroom decontamination plant.

BS 6524 ref 7 British standard method for the

determination of the surface resistivity of a textile fabric.

Helmke drum test on garment

ESD testing of cleanroom clothing

This method is appropriate for the testing of all

cleanroom clothing which has anti-static properties.

2.4
IEST-RP-CC003 ref 8

The Institute of Environmental Sciences and Technology

Contamination Control Division have produced a
Recommended Practice 003. This is currently published
as IEST-RP-CC003.3 Garment System Considerations for
Cleanrooms and Other Controlled Environments.

This document addresses the gowning of personnel as

an important aspect of cleanroom contamination control
and gives guidance on the selection, specification,
maintenance and testing of clothing for use in aseptic
and non-aseptic cleanroom conditions.

19
Garment cleanliness classifications are described for Category I, II and III and are shown below.

IEST-RP-CC003 Garment cleanliness classifications

Category Garment Type 0.3µm particles and 0.5µm particles and

larger/min larger/min
I I Frock <1700 <1000
I 1 Coverall <2000 <1200
I 3 Hoods <780 <450
II I Frock 1700 to 17000 1000 to 10000
II 1 Coverall 2000 to 20000 1200 to 12000
II 3 Hoods 780 to 7800 450 to 4500
III I Frock 17000 to 170000 10000 to 100000
III 1 Coverall 20000 to 200000 12000 to 120000
III 3 Hoods 7800 to 78000 4500 to 45000
Tables adapted and reprinted from IEST-RP-CC003 with permission from the Institute of Environmental Sciences and Technology (IEST). Copyright by IEST, www.iest.org

A test method is also described which may be used to determine the penetration of microbes through
cleanroom fabrics.

2.5
ASTM F51/00 ref 9

The American Society for Testing and Materials (ASTM) As this is a microscopic test method, fibres are
method F51/00 covers the determination of detachable separately identified and defined as particles longer
particulate contaminants 5 micrometres (µm) or larger in than 100 µm and with a length-to-width ratio exceeding
and on the fabric of cleanroom garments. 10:1.

ASTM F51/00 particulate test, removal of particles and microscopic evaluation

20
Garment classifications for decontaminated garments
are given for Class A, B, C, D, and E.

This test method may be used as a process measure to

determine the cleanliness of garments processed by a
cleanroom decontamination plant.

Garment cleanliness classifications given by ASTM

F51/00 are shown below.

ASTM F51/00 Garment cleanliness classifications

Class Maximum particles Maximum fibres/

5µm or greater/ o.1m2 fabric
0.1m2 fabric
A 999 10
B 4999 25
C 9999 50
D 14999 125
E 25000 175
Table reprinted with the permission of ASTM International.

2.6
BS EN 14065:2002 ref 10 Textiles -
Laundry Processed Textiles -
Biocontamination Control System
The standard provides the basis for a management
system for effective biocontamination control in
laundries, particularly those serving end-users such
as food processing and healthcare. The standard has
been developed using the principles of a Risk Analysis
and Biocontamination Control (RABC) system which is
closely analogous to Hazard Analysis Critical Control
Point (HACCP) systems.

21
 SECTION

3.0
Contamination Control and Staff

3.1
The Effect of Staff
A correctly designed and functioning cleanroom is Its two main layers are the epidermis (outer layer) and
extremely efficient in controlling contamination when dermis (inner layer) and part of the normal physiological
at rest. In most operational instances however people function of the skin is to continuously shed the surface
are required to be present in the room to carry out layer in a process know as desquamation. Everyday,
production processes. each person sheds their epithelial skin layer of
approximately 109 skin cells.

In this process the dead, dry cells of the epidermis form

skin scales which break off and leave the body surface,
especially when rubbed or abraded by clothing.
This skin debris leaving the body may be individual cells
or large rafts of cells, typically 5 to 60 micrometres in
size.

Epidermis

Cleanroom production

The presence of staff poses a major contamination

control challenge to the cleanroom as people produce
large numbers of both inert and viable particles
with 80% of the contamination found within most
operational cleanrooms estimated to be produced by
the occupants.

This “people contamination” comes from two main Cross sectional diagram of human skin
sources.
The cell fragments may be further broken down into
The first and major source of particulate comes from much smaller particles by abrasion with clothing, the
the skin which is the largest organ of the body, with a rubbing together of skin surfaces and break-down
surface area of around 1.5m2. caused by movement in air currents.

22
The normal microbial skin flora, which may include Physical activity also plays a significant role in particle
potential pathogens such as Staphylococcus aureus, will dispersion and increased activity generates and
also be present on this cell debris and viable micro- liberates more particles. This effect often leads to
organisms will leave the body surface as a consequence restrictions on types of movement and staff activity
of desquamation. Most micro-organisms found in within high grade cleanrooms.
cleanrooms are found in the air, rafted on particles of
skin. Cleanroom clothing, including gloves and masks, are
used to reduce the contamination being dispersed from
A healthy male can disperse to the air approximately the people wearing them. Cleanroom garments together
1000 bacterial cells per minute during active exercise with mask, goggles and gloves, providing full skin
with an average of around 200 cells per minute, females coverage for the wearer, will reduce the rate of microbial
generally disperse less. dispersion by a factor of approximately 20.

However when wearing high grade cleanroom clothing

and moving slowly a cleanroom operator may still
disperse approximately 1 x 105 particles > 0.5 μm per
minute, 30,000 particles > 5.0 μm per minute and up
to 15 microbe carrying particles per minute into the
cleanroom.

If the same operator was wearing lower grade

cleanroom garments, such as a cleanroom smock
or laboratory coat, the rate of dispersion into the
cleanroom could increase 10 fold.

Micro-organisms on skin cells

Normal human physiology will therefore continuously

produce significant quantities of both inert and viable
particles; however age, health, activity and clothing will
all have an influence on total dispersion.

The temperature differential between the wearer and

environment also has a large impact on the actual
number of particles liberated from the body into the
cleanroom.

Normal room temperature is around 20ºC and normal

body temperature 37ºC, this temperature difference
generates warm-air convection currents which rise from
the body surface into the cooler room air.
These rising convection currents carry with them large
numbers of particles into the room air which disperse
and normally fall by gravity (although in a unidirectional
flow area the particles are purged from the room by the
moving, filtered air-flow).

High grade cleanroom clothing

23
Saliva contains a large number of micro-organisms and
typically has a count of 107 bacteria per ml. Personnel
can emit as many as 40,000 microbe carrying particles
in a single sneeze. Well fitted face-masks are used to
control this contamination risk.

Street clothing

For example a simple morning walk with a pet dog along

a busy street will result in contamination of the wearer
from a wide range of both viable and inert particles and
Particle emissions during sneezing
fibres.
The second source of particulate and fibre
contamination introduced by staff comes from Without controls normal clothing can easily become
contaminants associated with the individual such as a major source of clean area contamination, and the
personal clothing, cosmetics, jewellery, hygiene and use of specially designed and constructed cleanroom
lifestyle. clothing has been developed to control and minimise
these contamination problems.
Non-cleanroom clothing (often referred to as ‘street
clothing’) is manufactured from fabrics designed to be Many cosmetics produce particulate contamination and
comfortable, fashionable and functional. There is rarely cleanroom staff are normally subjected to restrictions
a requirement to limit the production of particles or on the use of these products.
fibres from this type of clothing however, and non-
cleanroom garments usually produce large numbers The wearing of jewellery also presents various
of both. This means that specialised low linting-barrier problems and the loss of jewellery or metal fragments
fabrics must be worn as an alternative to street clothing can seriously affect many cleanroom products and
to eliminate this contamination control risk. electronic components are especially sensitive to these
contaminants.
The frequency of cleaning and the cleaning methods
used by staff for their clothing will vary considerably, Jewellery items also allow a build-up of dirt and micro-
adding additional loss of control for the cleanroom organisms and are difficult to clean effectively and may
operator. puncture or otherwise damage staff equipment e.g.
cleanroom gloves.
The design and fit of personal clothing will also have an
effect on the shedding and dispersion of particles from These sources of contamination normally result in
the wearer. Tight abrasive clothing will generate more restrictions on the wearing of jewellery in cleanrooms
skin particles and garments with wide openings e.g. however, where an item cannot be removed, it is usually
around the neck, will allow more particulate to escape. covered with adhesive tape. Spectacles can also present
a problem and it may be necessary to cover these with
Street clothing will also be contaminated by materials cleanroom goggles.
picked up during use and these will probably include fibres
and particles from furniture, pets, vehicles, smoke etc.

24
In lower grade clean areas where hoods and face masks
are not required beards and moustaches may have to
be covered and long hair controlled by hair nets and
snoods.

Simple changing room

High grade cleanrooms used for aseptic pharmaceutical

manufacturing will normally require entry through 2 or
3 separate changing areas, each at a higher classification
than the first and with the third changing area at an
Product handling in cleanroom.
Image courtesy of Photronics UK Ltd. equivalent classification to the production cleanroom.

Cross contamination by staff can also occur through

touching, sneezing and coughing with both inert
particulate and viable micro-organisms being
transferred to cleanroom clothing, surfaces and
products.

Documented staff training in appropriate cleanroom

behaviour together with a clear policy on reporting and
assessing minor illness is usually required to reduce
these contamination risks.

3.2
Entry and Exit Procedures High grade changing area

Entry and exit procedures should be developed to

Staff entering such a facility are likely to need to
enable staff to enter a clean area in an efficient and
remove all their street clothing and put on cleanroom
timely manner without compromising the integrity of
undergarments as well as full cleanroom outer garments
the cleanroom.
of coverall, boots, hood, mask, gloves and face cover e.g.
goggles.
For a low grade cleanroom this may mean a simple one-
stage change with staff donning perhaps a cleanroom
As the emphasis is on the control of micro-organisms
coat, hat and overshoes in a single changing area
exacting changing procedures will be required to
attached to the production cleanroom.
minimise cross-contamination of the garments and this
will be more critical than speed of entry.

25
For a microelectronics manufacturer large numbers of Exit procedures will also be required and in any areas
staff may need to quickly access the cleanroom but still where garments are not changed on entry, and so not
require full cleanroom hood, suit, boots and mask. As discarded on exit, suitable storage points must be
these garments are likely to be changed on a weekly provided for each staff garment set.
basis then clean air cabinets will be required for storage
in the changing areas. Containers for used garments and disposable items
must be provided and clearly identified and should
A check on the ESD performance of the clothing may be be sited so that they do not increase the risk of cross
required on entry. contamination with clean items.

Emergency exit e.g. in the event of a fire alarm must also

be planned.

3.3
Changing Areas
Changing areas are a key part of any contamination
control facility and should be built and maintained to
the same standard of construction as the cleanroom
production area itself. This allows efficient cleaning and
Grounding test station entry test decontamination to take place in areas likely to receive
periodic high levels of contamination from the staff
These variations in contamination control requirements passing through.
together with the physical layout of the building mean
that cleanroom entry procedures must be tailored to
each application.

When designing a staff entry system the following key

elements should always be considered;
a) What degree of contamination control is required in
the production area to be accessed?
b) What contaminants pose the main threat to the
products being manufactured e.g. fibres, viable
microbes, superfine particles, static discharge?
c) How many staff need to pass through the entry areas
and do they need to be able to enter quickly?
d) Are separate male and female changing areas required?
e) How much storage is required for personal possessions
and cleanroom clothing and where can it be
conveniently sited?
f) If hand washing and hand sanitisation is required how
and where can this be achieved? Well designed changing area.
Image courtesy of Medical & Scientific Structures

26
Whenever possible the changing rooms should be large
enough to easily accommodate not only the staff but
also the garment storage and discard equipment which
may take up considerable space.

Traffic lights above doors

As staff progress through a changing room they are

donning cleanroom clothing and this normally includes
some type of footwear.
Simple stainless steel garment storage pegs

Step-over benches are used to provide physical

separation between the areas of floor where non-
cleanroom footwear and cleanroom footwear is being
used, with the cleanroom footwear being put on whilst
the staff member is seated on the bench.

Basic garment storage and discard lockers

The changing areas should be maintained at positive

air pressure and where several consecutive changing Vinyl step-over bench
rooms are used in sequence e.g. a three stage change,
then a pressure cascade should be maintained from the These benches are often fixed but if the changing area
production area down through the changing areas. For is also used to allow transport of large items into the
multiple changing areas it is also usual to incorporate a production area then the step-over bench may need to
system to alert staff if the adjacent room door is open allow for this.
e.g. a traffic light system.

27
 3.4
Mirrors are usually provided to allow staff to check Gowning Techniques and Changing Procedures
their garments before entry to the cleanroom and
All gowning techniques and changing procedures
contamination control mats are sometimes used to
should be kept as simple as possible whilst still
reduce floor contamination at critical points.
maintaining the level of contamination control required
by the production process.
Hand washing facilities may be required but are
normally confined to the lowest grade changing area
Staff are required to use the gowning techniques several
with hand sanitisation often provided by alcohol hand-
times each day and significant production time can be
sanitiser dispensers.
lost in large production areas if unhelpful protocols are
introduced.

Unnecessarily complicated changing procedures can

also lead to staff shortcutting the system increasing the
risk of contamination.

If very strict and detailed changing procedures are

required then staff will need comprehensive training
and practice in gowning and will often be required to
pass a formal assessment before being allowed into the
production areas.

Thoughtful siting of changing equipment such as

personal lockers, garment dispensers and hand
sanitisers can add significantly to the ease and
efficiency of the gowning procedure and mapping the
flow of personnel through the system can assist in this.

Packaging and presentation of the cleanroom garments

will also be a factor in developing area procedures with
either individual garment sets provided for each wearer
or a pool of sizes available for selection.

Occasional visitors to the production areas will

also need to be considered and their requirements
Dispenser for alcohol hand sanitiser incorporated into the changing procedures

Types of garment and garment fastenings will also affect

gowning techniques, a simple centre zip coat being
easier to put on effectively than full cleanroom clothing
incorporating undergarments, dedicated footwear, hood,
boots, mask, goggles and gloves.

28
 Where multi-stage changing systems are required each
changing area will need to be considered individually
and specific gowning procedures will be required for
each changing room.

Each cleanroom production facility is unique and it will

therefore develop its own specific gowning techniques
and changing procedures based on the contamination
control requirements and plant layout.

As a general rule however changing procedures for each

area should always indicate;
a) What garments should be worn.
b) Where garments may be worn.
c) In what order the garments should be put on.
d) How garments should be worn and fastened.
e) The requirements for hand sanitisation.

Staff changing procedures can be usefully displayed

as posters in each area with visual guidance on the
gowning techniques required.

Visual guidance for changing areas

Typical cleanroom undergarments

If cleanroom undergarments are used it will be

necessary to determine where these can be worn
within the plant and many cleanroom manufacturing
operations require staff to change into dedicated
undergarments on entry to the building, only removing
them on exit to outside.

29
3.5 3.6
Training Requirements Garment Systems and Changing Frequency
Staff training is a key contamination control measure The level of contamination control required in the
for all cleanroom production units. Specific training will production area will largely determine the cleanroom
depend on the type of production and the degree of clothing system to be used.
contamination control required however the following
basic training should be provided for any staff working Cleanroom clothing acts as a mobile filter for the
in controlled areas; wearer and the basic rule is that more cover = more
contamination control, however the use of more
a) The theory and requirements of contamination control
clothing layers will result in an increase in clothing costs
systems and associated standards.
and the time taken for gowning to access clean areas.
b) The effect of people on controlled areas.
For some production processes it may also be necessary
c) Cleanroom clothing – purpose and function.
to consider special requirements for cleanroom clothing
d) Gowning, entry and exit procedures.
e.g. chemical resistance, flame retardancy or water
repellency.
Additionally training in GMP, basic microbiology, effects
of ESD and cleanroom cleaning may also be beneficial.
Internal and external courses together with training from
suppliers can provide various options and most benefit CHEMICAL
is usually obtained when courses are related to the
TYPE 5 TYPE 6 PROTECTION
specific working area and procedures of the trainees.

ANTISTATIC NUCLEAR BIOHAZARD

EN1149-1 PARTICLE EN14126

Clothing protection symbols

The frequency of change of cleanroom clothing is also

Staff training
critical to effective control and different approaches
have been adopted by bio-pharmaceutical and
For high grade cleanrooms staff are usually required to general industrial cleanrooms, reflecting the specific
successfully complete a full and documented training requirement for the control of viable contaminants in
programme and to pass a validation of gowning bio-pharmaceutical production.
competence before being authorised to enter controlled
areas. Individual staff training should be reviewed and In high grade bio-pharmaceutical cleanrooms it is usual
repeated on a scheduled basis, usually annually. to change outer garments on entry to the cleanroom
with undergarments being changed daily. If goggles
or captive footwear are in use then these are usually
retained and sanitised on a regular basis.

30
For lower grade areas a daily change of outer garments This document addresses the gowning of personnel as
and undergarments is usually appropriate. an important aspect of cleanroom contamination control
and gives guidance on the selection, specification,
In general industrial cleanrooms, including high grade maintenance and testing of clothing for use in aseptic
areas producing microelectronic components, a weekly and non-aseptic cleanroom conditions.
change of outer clothing is common with a daily
change of items such as launderable masks, gloves and It provides recommendations on the types of clothing
cleanroom socks if these are being used. appropriate for different ISO 14644-1ref 2 classified areas
and recommends change frequencies for these areas, as
As these garments are retained for several days then shown in the table below.
they must be stored in conditions which minimise
contamination and this is often achieved by using The MHRA publication Rules and Guidance for
hanging space flushed with filtered air. Pharmaceutical Manufacturers and Distributors ref 3 also
provides guidance on the type of clothing systems
Some published guidance is available and The expected in pharmaceutical manufacture.
Institute of Environmental Sciences and Technology,
Contamination Control Division, have produced a useful
Recommended Practice; IEST-RP-CC003.3ref 1

IEST-RP-CC003.3 clothing recommendations at different ISO classifications

ISO 14644-1 Air Cleanliness Class

Apparel Type
8 and 7 6 5 5 Aseptic 4 3 2 and 1
Inner suit AS AS R AS R R R
Hair cover R R R R R R AS
Woven gloves AS AS AS NR NR NR NR
Barrier gloves AS AS AS R R R R
Facial cover AS AS R R R R AS
Hood AS AS R R R R AS
Powered headgear AS AS AS AS AS AS R
Frock R AS AS NR N NR NR
Coverall AS R R R R R R
Two piece suit AS AS AS NR NR NR NR
Shoe cover R AS AS NR NR NR NR
Boot AS R R R R R R
Special footwear AS AS AS AS AS AS AS
Frequency of 2 per week 3 per week Daily Per entry Per entry Per entry Per entry
change
Key: R = Recommended, NR = Not Recommended, AS = Application Specific.
Tables adapted and reprinted from IEST-RP-CC003 with permission from the Institute of Environmental Sciences and Technology (IEST). Copyright by IEST, www.iest.org

31
Regulatory bodies, customer requirements and current
industry practices will all provide guidance on the
garment system and change frequency required for a
particular manufacturing operation. Cleanroom clothing
suppliers will also be able to provide advice and
technical specifications on the various clothing products
and options available.

These are discussed in further detail in Section 4.0

Reusable Contamination Control Clothing.

32
SECTION

4.0
Reusable Contamination Control Clothing

4.1
Reusable Cleanroom Clothing - the Three
Principal Requirements

Reusable cleanroom clothing has three principal

requirements.

1. Reusable cleanroom clothing must act as an effective

contamination control measure appropriate to the area
where the clothing is in use. The clothing must control
the loss of particulate from the wearer and additionally
not itself provide a source of particulate or fibre
contamination. Control of electro-static discharge (ESD)
may also be an additional key requirement.

2. Reusable cleanroom clothing must be comfortable

and practical for the wearer whilst providing a cost-
effective contamination control solution for the specified
manufacturing operation.

3. The environmental impact of reusable cleanroom

clothing must be as low as possible throughout its life
cycle.

These three requirements together form the basis of

all processes involved with the manufacture, use and
processing of cleanroom clothing.

Contamination control clothing

33
4.2
Cleanroom Fabrics
Fabrics for cleanroom use
Barrier fabrics have been developed and continuously
improved since the introduction of contamination
control techniques in the 1960s.

Many different manufacturers of technical fabrics

throughout the world have invested large amounts of
time, effort and resource to produce the very effective
contamination control textiles which are currently
available.

The fabrics which have been developed for use in

contamination control clothing are of 3 basic types. Fabric manufacture
a) Woven.
b) Laminated. Weaving produces effective contamination control
c) Non-woven (which are largely used in disposable textiles but achieving the unusual requirements of these
items and discussed in Section 5.0 - Disposable fabrics requires special techniques.
Contamination Control Clothing).
Standard yarns, produced by twisting together short
Woven fabrics staple fibres, are not suitable for cleanroom fabrics.
Fabric weaving is one of the oldest human technologies With fabrics constructed in this way, fibre ends,
dating back to at least 5000 BC. It consists of lacing protruding from the yarn, are constantly broken off
together long vertical yarns (the warp) with horizontal during normal wear resulting in both fibres and small
yarns (the weft) to produce a sheet of fabric which may particles being shed into the environment.
then be cut and joined to produce textile items.

Yarns, Fibres and Filaments

The yarns of many woven fabrics are produced
by twisting together short staple fibres to form a
continuous cohesive thread. A single yarn being called a
single ply. These single plies may then be combined to
form thicker yarns which become the weaver’s warp and
weft, woven together to produce the finished fabric

A common example of a class of fabrics produced in this

way are the polyester and cotton mixtures, often called
‘polycottons’, extensively used in the manufacture of a
whole range of textile items including clothing.
Photomicrograph of staple yarn
The choice and blend of materials used for the yarn,
together with the type and tightness of the weave,
influence the look, feel, comfort and strength of the
final fabric and almost endless variations are possible,
producing the astonishing range of woven fabrics we
see daily.

34
Contamination control fabrics therefore require the use Sterilisation by gamma irradiation and autoclaving will
of filament yarn. These consist of very long continuous accelerate fabric deterioration but polyester fabrics
fibres twisted or simply grouped together to form the still have an acceptable life expectancy of around 50
yarn. The filaments are produced in a single smooth gamma sterilisation cycles at min 25 kGy.
strand and their continuous nature means that no ends
protrude from the woven fabric surface and so the Polyesters will dye successfully, are rarely allergenic and
possibility of fibre and particle liberation from the fabric are readily accepted by most wearers. The material does
is greatly reduced. Silk is a naturally occurring filament not absorb moisture in the same way as many natural
and man-made filament yarns include extruded fibres and is readily available and competitively priced.
polyesters.
In addition polyesters are also used to make a wide
range of items as diverse as bottles, films, and canoes
and this gives a route to re-cycling at the end of useful
garment life.

These factors mean that currently most re-usable

contamination control fabrics are woven from 100%
filament polyester.

Weave
The weave used to manufacture contamination control
fabric is critical in producing the desired filtration and
Photomicrograph of filament yarn wearer comfort characteristics.

The filaments and yarns also lie very closely together As a consequence of the weaving process holes occur in
and this allows fabric to be produced with a tight, the fabric where the warp and weft yarns cross. The size
smooth, consistent finish. of these holes in the fabric, often referred to as fabric
pores, determine the rate at which particulate, air and
Filaments can be extruded in different diameters and water vapour will pass through.
these can give the final fabric different characteristics
such as appearance, feel and performance. For non-cleanroom garments this usually means that
It is also possible to texturise the yarn to produce a less the fabric is woven with a loose weave and large pores
smooth surface finish to the fabric and a different feel which produces a soft, breathable material. This allows
against the skin. the wearer to quickly lose heat and moisture vapour and
maintain a comfortable environment within the clothing
Polyesters resulting in maximum wearer comfort.
The principle materials used to manufacture cleanroom
woven fabrics are polyesters, a category of polymers
which contain the ester functional group in their main
chain.

Polyesters have been shown to produce very stable

fabrics capable of withstanding repeated wear and
wash cycles and are incorporated into polycottons for
this reason.

35
 Magnified images of fabric reveal that woven cleanroom
fabric is not a thin, flat layer but that it has complex
three dimensional structures with the pores passing
from one fabric face to the other rather like tunnels.
This three-dimensional structure gives a depth-
filtration effect and increases the likelihood of particle
entrapment whilst allowing both heat and moisture
vapour to pass through.

Plain, twill and satin weaves can also be used to

produce different fabric characteristics and appearance.
In the manufacture of different contamination control
fabrics both plain and twill weave have been used and
Photomicrograph of polycotton fabric
both types of fabrics are used effectively in the full
For contamination control fabrics this presents a range of cleanrooms.
problem as the larger the pore size the more the fabric
can “breathe” but at the same time increasing pore size
allows more particulate to escape from the wearer and
reduces the barrier properties of the clothing.

Cleanroom fabric is therefore a compromise, the weave

selected to produce a fabric pore size which gives an
acceptable level of wearer comfort whilst still acting as
an effective particle barrier.

Photomicrograph of plain weave cleanroom fabric with ESD yarn

Photomicrograph of cleanroom fabric

Tightly woven cleanroom fabrics must therefore have

small fabric pores which are consistent throughout the
material.

As a guide polycotton fabric will have a pore size of

around 65 micrometres and a cleanroom polyester
fabric will have a pore size of approximately 18
micrometres. (See section 4.6 for details of test
methods)

Photomicrograph of twill weave cleanroom fabric with ESD yarn

36
Conductive yarns for Electro Static Discharge In the very highest level of control it is useful to have
(ESD) Control all the individual fabric panels of a garment electrically
The majority of woven cleanroom fabrics also have a connected together and each part of the garment set
conductive fibre incorporated into the fabric during the connected to the next e.g. hood to coverall, coverall to
weaving process to help in the control of ESD. These boots, so that charge being generated on any part of the
fibres are often visible as a black stripe or grid. clothing can be quickly conducted to earth.
The conductive fibres can be made in a variety of
ways with the conductive material, usually a carbon Calendering
compound, embedded into a polyester base. After manufacture the surface of the fabric can be
finished by passing through heated rollers at high
Polyester pressure in a process known as calendering. This melts
and flattens the surface and closes the fabric pores
Carbon slightly. (Ceramic Terylene was a calendered material
adopted for early cleanroom use which was originally
developed for workers in the ceramic industry who
needed to be protected from the fine dust in their
working environment).

Over time, repeated high-temperature laundry

Carbon encapsulated in polyester producing different processing relaxes the fabric and the calendering effect
configurations of conductive yarns
is lost. If the calendering process is not very carefully
controlled it can also lead to local overheating and
Triboelectric charging is a phenomenon which most
damage, eventually causing the surface of the fabric
people experience from time to time when a significant
to breakdown. These factors mean calendering is now
static charge builds up on their clothing, often due to
rarely used as a finish for contamination control fabric.
rubbing together synthetic fibres.

Once the potential is high enough and a route to earth

Laminated fabrics
becomes available the charge can dissipate violently
Laminated fabrics are constructed by bonding together
and the electric shock sometimes experienced when
different layers, often a woven and non-woven
applying a key to a car lock is a common example of this
combination. There can be two or more layers.
effect. As well as being uncomfortable the discharge of
high voltage sparks in this way can cause a fire hazard
and can also cause extensive damage to microcircuits, Particulate
which may not be immediately evident. Air, water
vapour

During use static electrical charge accumulates in this

way on cleanroom garments made from synthetic fibres
and migrates to the conductive yarns.

This charge may then be dissipated by the conductive

yarns being grounded to earth or by corona discharge
into the air.

In production areas where control of static electricity is 3 laminated

materials
a key element of the contamination control requirement
care is taken to ensure that the charge on the garment
passes safely to earth and this is often achieved by the
Diagram of fabric laminated from 3 layers
use of conducting straps or flooring.

37
 4.3
A membrane containing pores of known size is Cleanroom Clothing Design and Construction
commonly used as part of the laminate construction.
Design
PTFE is a commonly used membrane material and
Cleanroom clothing has two basic design requirements;
laminated fabrics of this type have become popular in
the manufacture of rain-proof clothing. 1) To act as an effective contamination control barrier and
not itself be a source of contamination.
The pores in the membrane are normally less than I 2) To be as comfortable and practical as possible.
micrometre in size and so act as a very effective particle
These requirements have led to the development of
barrier whilst still allowing air and moisture vapour to
several basic styles of reusable cleanroom clothing.
pass through.
Cleanroom undersuits and general clean-area wear.
Cleanroom coats.
By laminating a coating or membrane to a cleanroom
Cleanroom coveralls.
filament fabric very effective control of particulate can
Cleanroom captive shoes and overboots.
be achieved in high grade cleanroom operations whilst
Cleanroom hats and hoods.
still giving acceptable wearer comfort.
Simplicity of design is preferred with emphasis on good
These types of fabric can also be used when a fit to the neck, wrists, ankles and face to reduce particle
waterproof cleanroom garment is required although loss from these openings.
this will also require additional stages in garment
manufacturing such as seam taping.

Air cannot easily pass through contamination control

fabrics however and any cleanroom garment must have
tight fitting closures at the garment openings e.g. neck,
to produce an effective seal and prevent particles being
pumped out by the movement of air trapped inside the
garment.

Laminated fabrics cannot be washed and dried by a

cleanroom laundry at high temperature and so it is not
possible to achieve thermal disinfection. These fabrics
will also break down or de-laminate with repeated
sterilisation cycles by autoclave or gamma irradiation.
Laminated contamination control fabrics are more
expensive than other types of fabric and although very
effective have not been widely used in cleanroom
manufacture with the exception of some high-grade
microelectronics areas.

Close fitting cleanroom clothing

Personal adjustment to these closures is usually

achieved by studs allowing a degree of variation to suit
individual wearers. Garments should be designed and
fitted to allow ease of movement, especially during
gowning, and unisex styles in a range of sizes are the
normal choice.

38
Pockets are not normally an option but loops and 3) Sewing thread.
open pouches can be provided to accommodate pens, All sewing thread used is silicone-free continuous
badges and small tools which may be required by some filament polyester. Normal sewing threads are not
staff. Garment earthing studs, electrically interconnected suitable as they are manufactured from short staple
garment fabric panels and interconnected garment filaments which can produce fibres and particles.
wearer sets may also be required for ESD sensitive
applications.
4.4
Construction Cleanroom Clothing Fixtures and Fittings
Specialised manufacturing techniques must be
Tapes, zips, studs and buckles are used to adjust and
employed when constructing contamination control
fasten cleanroom garments whilst various compounds
clothing. These methods are more complicated than
are used for cleanroom shoe and boot soles. Elasticated
those used to manufacture normal workwear but are
cuffing materials are often used for the wrist closure of
required to minimise the possibility of contamination
coats and coveralls. (Velcro is not routinely used as it can
occurring from the garment itself.
easily snag and also holds fibres and particles).

1) Sealed edge fabric panels.

These fixtures and fittings come in a variety of materials,
Fabric panels are cut using a controlled and graded
colours and patterns, however any materials used must
pattern before being sewn together to manufacture
not be a source of particulate and fibres and must be
the garment. The edges of the panels are sealed before
able to withstand repeated wear and decontamination.
sewing begins and this ensures that no fibre break-out
When sterilisation of the garments by autoclave or
occurs within the enclosed seams.
gamma irradiation is an additional requirement then any
fixtures and fittings should not be deformed or broken
2) Fully enclosed seams.
down by these processes.
All seams are totally enclosed using a double stitching
technique. This method encapsulates all the cut and
Electrically conductive tapes, studs and sole materials
sealed edges of the fabric and is in sharp contrast to
may also be a special requirement for ESD controlled
overlocked seams used for most garment construction.
areas.

Clear data showing the performance of all garment

fixtures and fittings will be available from the garment
supplier.

4.5
Special Cleanroom Garment and Fabric
Requirements

Cleanrooms are used to produce a very wide range of

products and the emphasis of contamination control
can range from the control of surface finish, removal of
micro-organisms or control of electro-static discharge
Double stitched garment seam construction (ESD).

39
These varied requirements mean that many different Flame retardancy
manufacturing processes are employed and some of In some instances flame retardant garments or
these will pose unusual contamination control risks and additional protective layers e.g. arm guards, may be
problems. required to protect the wearer from sources of heat.
Cleanroom compatible fabrics are available to meet this
Special cleanroom fabrics have been developed which need.
help to solve these specific problems.
Anti-microbial fabric
Water repellent fabric Several different anti-microbial materials have been
Cleanroom fabrics can be used which will stop the developed for cleanroom clothing and applied as a
penetration of water droplets produced as a spray. surface finish or incorporated into the fabric yarn.
These fabrics are often referred to as spray resistant, These may be useful in reducing the build up of
water resistant or shower proof and are not waterproof. micro-organisms on cleanroom garments worn over an
The fabric finish used to provide this protection extended period of several days and especially if the
does not significantly affect the other performance clothing is damp or wet for a significant time. Issues
characteristics of the fabric. concerning the introduction of anti-microbial chemicals
into the cleanroom and skin-contact with the wearer
Waterproof fabrics must be considered.
Waterproof fabrics are able to resist the penetration
of significant volumes of water falling onto the fabric Electro-static discharge (ESD)
surface and the degree of water resistance is measured Control of ESD is of particular significance in cleanrooms
by the height of the column of water which can be where fire and explosion risks are present or where
suspended above the fabric before water seeps ESD sensitive components are being manufactured.
through. Different levels of control are required and section 2.3
- ESD requirements and standards, gives details of the
Laminated fabrics are especially useful for this current guidance.
application and normally provide a degree of
breathablity to maintain wearer comfort. The great majority of cleanroom fabrics incorporate an
(Note ; If waterproof garments are required then taped electro-conductive yarn (as outlined in section 4.2), as a
seams and waterproof closures such as zips must also grid or stripe into the weave and this provides basic ESD
be used during manufacture). control.

Chemical resistance When higher levels of control are required then

Cleanroom fabrics which can protect the wearer from specially constructed garments must be used which
chemical splashes are produced and fabric information achieve conductivity between individual garment fabric
will be available to indicate the level and type of panels and between the separate garments in the
protection afforded. wearer set e.g. coverall, hood and boots. This is usually
achieved by incorporating conductive materials into the
It is recommended that when protection is required garment during manufacture.
against specific production chemicals controlled
laboratory testing is carried out to ensure that the fabric These type of clothing systems are usually permanently
will perform effectively with the specified chemicals. earthed during use either by earth straps or through
Garment suppliers will be able to arrange these tests. conductive flooring. Sleeve-to-sleeve and point-to-point
testing will be required throughout garment life to
ensure the garment ESD system is functioning correctly.

40
 The following list gives examples of useful test methods;
however, different National Standards and tests are used
by different fabric manufacturers.

It is therefore recommended that when selecting

cleanroom fabrics, samples are subjected to the same
test methods, preferably carried out by the same test
house at the same time, to obtain directly comparable
results.

Fabric pore size

BS 3321 ref 1 Method for measurement of the equivalent
pore size of fabrics.

The bubble point test is used to establish the size of

the pores which pass through the fabric from one side
to the other. Pore size results from the tightness and
accuracy of the weave.

Point to point ESD test on cleanroom garment Decreasing pore size gives greater particle hold out
and therefore better filtration but also decreases the
Special designs
ability of the fabric to transmit air and water vapour and
Unusual designs of contamination control garments or
therefore reduces wearer comfort.
equipment covers may be needed. Cleanroom clothing
manufacturers will be able to advise on the best
For a filament polyester fabric the pore diameter will
approach to produce individual tailor-made items.
typically be around 18 micrometres or less.
This can be especially useful for production machinery
As a comparison a polycotton fabric will have a pore size
and equipment where items such as parts bins or
of approximately 65 micrometres.
production robots may need to be covered to reduce
contamination.
Particle holdout efficiency
British Textile Technology Group (BTTG) Particle Barrier
4.6
Efficiency (Shirley method 22) ref 2.
Fabric Test Methods
Testing contamination control fabrics A direct particle challenge test is used to estimate the
In order to assess the suitability of fabrics for different number of particles of different sizes filtered out by the
contamination control systems it is necessary to test fabric.
a range of performance characteristics both of the
material itself and also of garments constructed from The fabric is subjected to an airstream containing a
the fabric. known number of particles with a range of sizes. The
number of particles passing through the material is
A variety of standard tests can be used to assess factors measured and the percentage of particles filtered out
affecting contamination control and wearer comfort and by the fabric can be calculated. This is reported for each
to give a direct comparison of different fabrics. particle size as a percentage holdout.

A typical woven high-grade filament fabric and

polycotton will produce the following results.

41
 Particle size range % holdout % holdout A typical result for a woven filament barrier fabric would
(micrometres) Filament fabric Polycotton be about 45 litres of air per square metre of test fabric
0.2 - 0.3 50 14 per second and for polycotton approximately 170 litres
0.3 - 0.5 85 22 of air / square metre of test fabric per second.
0.5 - 1.0 92 27
1.0 - 3.0 92 32 If air can pass easily through the fabric then the body
3.0 - 5.0 92 32 temperature of the wearer is more readily adjusted
resulting in a more comfortable garment.
Dry linting propensity
BS 6909 ref 3 1988. Method for generation and counting Static dissipation behaviour
of the airborne linting propensity of fabrics in the dry BS EN 1149 ref 6. Protective clothing: Electrostatic
state. properties. Test method for measurement of surface
resistivity.
This test examines the numbers of particles generated
by the fabric itself whilst undergoing a standard flexing Gives details of tests to investigate the electro-static
under mild abrasion. dissipative properties of fabrics.

Water vapour permeability Abrasion resistance

ASTM E96 ref 4. Standard test methods for water vapour BS EN 530 ref 7. Abrasion resistance of protective clothing
transmission of materials material.

This test is used to establish the rate at which water This test gives an indication of the likely wear
vapour will pass through the fabric and is measured characteristics of the fabric over time.
in grams per square metre of test fabric per hour. A
high-grade barrier fabric will typically give a result of 20
grams per square metre of fabric per hour. Polycotton 4.7
fabric will be approximately 28 grams per square metre
Body Box Test
of fabric per hour.
One of the best methods to study the types and
This test gives an indication of garment comfort as numbers of particles dispersed from personnel is
the faster moisture vapour can disperse from the skin to utilise a body box or a dispersal chamber. This
surface the more comfortable the wearer feels. can be utilised to study the effectiveness of various
types of cleanroom garments. Dispersal rates under
Air permeability varying conditions of movement can be assessed and
BS EN ISO 9237 ref 5. Textiles. Determination of the the body box can also be used to investigate if any
permeability of fabrics to air particular individual is an abnormally high generator of
contamination.
This test method is used to assess the rate at which
air can pass through the fabric and gives a further IEST-RP-CC003.3 ref 8 gives full details of a recommended
indication of wearer comfort. particle dispersion test procedure.

The results are obtained in litres of air per square The picture overleaf shows a typical body box,
metre of test fabric per second at 0.98 mb pressure consisting of a metal framed glass booth, approximately
differential. 0.75m x 0.70m x 2.5m that can be accessed via the door
at the front. A variable fan, located above the chamber,
provides a constant stream of air, via a HEPA filter, into
the chamber.

42
Typically air is supplied at just over 700 l/min, and
balanced by the removal of air by a high-volume
bacterial sampler operating at 700 l/min, and an
airborne particle counter operating at 2.83 l/min (1ft3/
min), at the sampling port at the rear base of the unit.
A slight positive pressure is maintained inside the
chamber to ensure that no contamination enters
the chamber from outside which can be checked by
observation of the exhaust port flaps at the adjacent
side of the base.

The subject enters the chamber wearing the required

clothing and is usually requested to march to the
beat of a visible metronome. After a period of about
1 minute, the bacterial air sampler is switched on for
a defined period and the microbe carrying particles
(MCPs) deposited onto microbial media plates are
subsequently incubated and then the bacterial colonies
counted.

The particle counter simultaneously records the total

particle concentrations during the exercise.

Whyte ref 9 used a similar body box to test 55 people

(30 females and 25 males) wearing basic cleanroom
garments, manufactured from woven polyester fabric,
which had a pore diameter of 25µm. A coverall was
worn and its trouser bottoms were covered by knee-
length boots.

Disposable latex gloves, disposable mask and woven

polyester hood, were also worn, leaving only the eye
area uncovered.

The graph shows the dispersion rate per minute of

MCPs, particles ≥0.5µm, and ≥5µm, obtained from the
55 people wearing cleanroom garments. The counts Test subject in a body box
on the left are from females, and those on the right are
males. Each person was marching to the beat of a metronome
(1 beat/s), while swinging one arm, and then the
other, up to their shoulder. Large variations in airborne
dispersion from people were apparent, and the rates of
dispersion of MCPs, particles ≥0.5µm, and ≥5.0µm were
interlinked i.e. high dispersers of one type of particle
would disperse high rates of particles of the other two

43
types, and vice versa. It has been demonstrated that It was found that men dispersed greater numbers of
the reduction in the dispersion of MCPs and particles MCPs and particles. (It is well established that males
by the use of cleanroom garments was determined disperse more MCPs than females).
by the tightness of the weave of the cloth, and the
design of the garments. The more occlusive the fabric The ratios of the number of particles dispersed of ≥0.5
and garments, the greater the reduction in airborne µm and ≥5.0 µm diameter, to the number of MCPs,
dispersion, and more larger particles would be retained was found to be 5800 and 210 for the cleanroom
than smaller particles. garments tested. These ratios will vary depending on
the personnel tested, the design of the clothing, the
The relative dispersion from males and females was also type of clothing fabric, and whether the fabric was new,
studied. unwashed and unsterilised.

MCPs and particles from 55 people wearing cleanroom garments. (30 females and 25 males)

44
4.8
Cleanroom Undergarments
The clothing worn beneath the outer cleanroom
garments is of considerable importance in controlling
the contamination released into the cleanroom.

If normal street clothes are worn under outer cleanroom

clothing then these garments will have great variation in
fabric type and soiling levels.

Body box testing shows that particles are released

through the cleanroom garments and a proportion
of any contaminants released will be from the
undergarments.

It is therefore essential that in high grade cleanrooms

undergarments are used and are manufactured from
a fabric that does not itself shed large numbers of
particles or fibres. The undergarment layer will also
provide additional filtration for the wearer thus reducing
the particulate challenge to the outer garments and the
cleanroom.

As these garments are worn next to the skin, fabrics

must be used which provide a high level of wearer
comfort. Fabrics with a soft “feel” and the ability to
wick moisture away from the skin will usually be most
acceptable.

Fabrics which are dark in colour and non see-through

are preferred.

When control of electro-static dissipation (ESD) is a key

area for contamination control then an undergarment
fabric with ESD properties is required.

Cleanroom undergarments are usually a two piece set of

tunic and trouser (sometimes called PJs – pyjamas) and
loose, comfortable-fitting styles are needed.

Elasticated trouser ankles prevent dragging on the floor

and the tunic is usually short sleeved. A long sleeved
tunic provides a more effective barrier to the release of
skin particulates; however, the cuffs can become wet
during hand washing and produce a source of microbial
contamination.

Cleanroom undergarment set

45
 SECTION

5.0
Disposable Contamination Control Clothing

This section describes the materials, manufacture, As disposable clothing for staff during the cleaning and
characteristics and testing of disposable cleanroom commissioning phases of new builds.
clothing. Other disposable cleanroom items, such as
For use as a back-up for re-useable garments; especially to
cleaning wipes, are discussed in Section 7.0 Cleanroom
accommodate visitors, contractors and new starters.
Cleaning Methods, Equipment and Cleanroom Ancillaries.
When it is necessary to have cleanroom clothing which
Guidance on the selection and purchasing of cleanroom is also required to act as Personal Protective Equipment
disposables for specific manufacturing environments (PPE) for the wearer and to be CE marked. This is often
is provided in Section 9.0 Planning, Sourcing and the case for bulk active pharmaceutical ingredient (API)
Optimising Cleanroom Consumables Supply. manufacturing when specific chemical repellency is
needed.

To provide the best contamination control option e.g.

5.1 cleanroom gloves.
Disposable Clothing
Non-woven fabrics
In the majority of cases cleanroom clothing is The fabrics used to produce disposable cleanroom
manufactured from re-usable cleanroom fabrics which garments are not produced by a weaving process and
can be processed, decontaminated and worn many are therefore referred to as non-woven fabrics.
times and Section 4.0 Reusable Contamination Control
Clothing, and 6.0 Cleanroom Garment and Consumables
Decontamination - Plant and Process give full details of
these garments and decontamination systems.
In some applications however it is appropriate to
consider disposable clothing items, which although
generally low comfort and high cost, are available in a
wide range of options and are simply disposed of after
use.

Suitable applications for disposable cleanroom clothing

may include the following:
For use in remote or difficult to access locations.

When very low numbers of cleanroom garments are

required.

When cleanroom clothing is worn infrequently.

When heavy staining with oils, greases, paints and inks

would make decontamination of reusable clothing
impossible.
Non-woven contamination control fabric
Where garments may be contaminated with harmful
biological, chemical or radioactive substances.

46
Non-woven fabrics are produced using spunlaid Laminated non-woven fabrics are also available and
techniques from plastic polymers such as produced from layers of different materials glued
Polypropylene, Nylon and Polyester. together to produce different characteristics of strength
and permeability.
Filaments of the material are extruded then drawn and
laid on a moving screen, called a web former, to form a
filament web
Air and
water Water
vapour
The filament web can be made into a finished fabric by
Contamination
the application of heat and pressure without the need
for additional binding agents.

Fabrics produced in this way are usually referred to as

spunbonded non-woven fabrics.

Outer
layer

Mid layer

Inner layer

L aminated 3 layer non-woven fabric

There are many different types and brands of non-

wovens available but the most commonly recognised
Photomicrograph of non-woven fabric brand is TYVEK™ which is a registered trademark
(DuPont).
Variations in the method of producing the filaments
have been developed to produce non-woven fabrics Disposable clothing for use as Personal Protective
with different characteristics. Equipment (PPE)
When a risk assessment has identified that a specific
Meltblown non-wovens are produced by using a cleanroom task requires the use of PPE then disposable
spunlaid technique which extrudes and draws molten garments which are CE marked to confirm suitability
polymer resins with heated, high velocity air to form for the task must be chosen. The clothing must
much finer filaments. The filaments are again cooled also be compatible with the contamination control
and collected as a web onto a web former before being requirements of the area of use.
made into a finished fabric.
European directives ref 1 require that all PPE must be
Flashspun fabrics are produced by a further variation of certified according to category I, II or III.
spunlaid technology; a solution of polymer and solvent
Category I clothing is identified as simple design with
is extruded under conditions which produce rapid
minor risk which can be identified by the user. Garments
solvent evaporation; this causes the extruded filaments
are labelled with a CE mark only.
to split further into a highly intricate and fine web which
is again collected onto a web former before being made Category II describes all PPE except those in category I or
into the final fabric. III. Garments are labelled with a CE mark only.

47
 5.2
Category III garments are identified as complex design Bodywear
and intended to protect the wearer from risk of serious
Non-woven fabrics can be used for the manufacture of
or fatal injury which may not be identified by the wearer
all types of products and this is reflected in the large
in sufficient time. Category III garments are labelled with
number of disposable garment styles and ranges which
the CE-mark plus a four digit code of the relevant notified
are available. White is the usual colour for cleanroom
body.
disposable garments, however other colours are also
available.

Category III garment CE label

In addition the garment type indicates the kind of

protection offered by protective clothing as defined by
European Standards ref 2.
Category III PPE includes six Types
Type 1 - Gas-tight clothing
Type 2 - Non gas-tight clothing
Type 3 - Protection against pressurised liquid chemicals
Type 4 - Protection against liquid aerosols Non-woven contamination control clothing
Type 5 - Protection against airborne solid
When selecting disposable clothing for use in a
particulate chemicals
controlled environment it is important to select a
Type 6 - Limited protection against mist
non-woven fabric which has the appropriate filtration
It is important to note that if disposable garments are requirements and low shedding characteristics. Seam
required for PPE then advice must be obtained from a construction varies considerably and care must be
Health and Safety professional to confirm the correct taken to ensure that the manufacturing method does
choice of clothing. not allow particles to escape from the garment via this
route. Fixtures and fittings such as thread, studs and
When disposing of contaminated items after use, safe elastic must also be compatible with the cleanroom.
and acceptable disposal procedures must be identified
and used.

48
Many disposable clothing items are sold direct from The type of non-woven material used and the standard
the producer without any cleaning or decontamination of manufacture, finishing, packing and sterilisation will
process following manufacture. Such garments are all have considerable impact on the final cost of the
completely unsuitable for cleanroom use as they are garment.
likely to be heavily contaminated with particulates and
fibres from the manufacturing process and may also be When ESD (electro-static discharge) control is required
a significant source of bacterial and fungal spores. then disposable garments which incorporate ESD
control properties must be selected. ESD control is
When disposable garments are required for cleanroom often achieved by the use of sewn-in conductive tapes
use it is therefore necessary to ensure that the clothing or conductive fabric finishes and full data on garment
has been effectively cleaned, decontaminated, packed static dissipation properties will be provided by the
in a cleanroom environment and if required sterilised supplier.
before use.
Coat
Centre fastening, lancer and “Howie” style coats are all
produced with zip or stud fastenings. Different pockets,
cuff closure, fastening options and colours are available.

Photomicrograph of unprocessed non-woven garment showing surface

contamination

Photomicrograph of processed, decontaminated non-woven

garment surface

Non-woven cleanroom coat

49
Top and Trouser Where a high level of control is required a disposable
Two piece bodywear, comprising a separate top and cleanroom coverall, complemented with disposable
trouser, can be obtained in a range of styles. overboots, latex gloves, mask and goggles is
appropriate.
Coverall
Disposable coveralls are probably the most commonly
used disposable cleanroom body garment.
A number of styles are available from the basic centre
zip coverall to coveralls with incorporated hood and
those with integral hood and overshoes (often called a
“Bunnysuit”)

One piece non-woven coverall with overboots, gloves, mask and

goggles

Apron
Non-woven cleanroom ‘Bunnysuit’ Disposable aprons may be worn to protect re-
usable cleanroom garments from excessive wear or
contamination from stains or liquids. They may also be
required as PPE to protect the wearer from chemical or
biological hazards. Aprons can be obtained in a variety
of styles and materials to suit the specific application.

50
 Hair is composed mainly of the protein keratin and the
diameter of human hair can vary from approximately 30
to 180µm, the average being approximately 100 µm,
with the length varying from a few mm to many cm.
Because of its location on the body surface and its
contact with the skin it can be contaminated with a
range of non-viable particles and micro-organisms.
Hair grooming products may also be present on the hair
surface.

A range of hair control clothing options are available for

cleanroom use.

The most basic control is provided by hair net, mob hats

and beard snoods.

Mob hat

Disposable apron, complemented with gauntlets and face visor,

worn to protect the wearer from chemical hazards

5.3
Headwear

Head coverings are worn to achieve three contamination

control objectives;
• To contain hair and prevent loss of hair into the
controlled environment.
• To contain droplets produced from the nose and mouth.
• To control the dispersion of skin particles from the head.

Control of hair and skin particles

Head and facial hair can pose a threat to any controlled
environment and some controlled manufacturing
environments are especially sensitive to hair
contamination e.g. tablet manufacture and high grade
Beard snood
surface finishing.

51
These are usually disposable items made of a non- Goggles which are specified for contamination control
woven material. Different strengths and densities of purposes seal against the face and overlap the hood
fabric are available and identified by the weight in g/m2. and mask , providing full facial coverage to give the best
control of both facial hair and skin.
These items are normally secured by elastic fastenings
which can be single or double strength and must be If the goggles are also required to protect the wearer
large enough to enclose all head or beard hair. then suitable PPE goggles must be selected.
Mob hats and beard snoods are not usually supplied Cleanroom goggles are available as single use
cleaned and decontaminated as they are used as a disposable items but more usually are retained by a
primary control in direct contact with the hair. They can specified wearer and sanitised between use, typically
be supplied in a range of colours which can be useful by wipe down with sterile IPA or IMS. They may be
when such items are dedicated to different controlled sterilised by gamma irradiation, steam (autoclave) or
areas, the colour readily identifying a particular zone ethylene oxide (ETO).
and helping to control the area of use.
A comfortable fit is usually achieved with a soft PVC
Disposable mob hats may be used without additional surround with a broad, adjustable elasticated head
headwear in low grade manufacturing areas, however strap preferably made from food grade rubber or
when higher levels of contamination control are nitrile and fitted with high grade non-misting lenses to
required then it is usual to wear a mob hat underneath allow undistorted vision. The lenses typically would be
an additional covering such as a full cleanroom hood manufactured from polycarbonate to reduce the risk of
which will give the best control of not only hair but also breakage.
of skin particulates and micro-organisms dispersed from
the head.

Disposable cleanroom hoods of various styles,

manufactured from non-woven fabrics are readily
available. They can be supplied as decontaminated,
sterile or non-sterile.

When very high levels of control are needed then visors,

visor masks or goggles can be used to contain loss of
hair from the eyebrows and eyelashes and additionally
Typical cleanroom goggles
give protection against the dispersion of particles from
the skin of the upper face.
Some form of ventilation of the goggles is normally
required to prevent excessive condensation forming
Disposable visors or visor masks do not form a seal
during use. Typically this may take the form of a series
against the face and therefore provide a limited degree
of ventilation holes, or adjustable vents, designed to
of contamination control however they may be required
prevent a direct transfer route into the cleanroom and
as PPE to protect the wearer from splashes of product or
fitted on the upper (forehead) side of the goggles to
disinfection solutions.
ensure contamination isn’t transferred by gravity from
holes on the underside.

Designs are available to accommodate staff who

require prescription spectacles. Cleanroom goggles
are available which fit over spectacles or alternatively
prescription lenses can be fitted inside.

52
 Masks have been used by Medical Professionals for
many years especially during surgical procedures. Masks
were originally worn to reduce the number of airborne
micro-organisms near open wounds and thus reduce
post operative infections. More recently surgical masks
have also been seen as a way to protect the wearer from
cross-infection and are often used in conjunction with a
face shield to help protect against blood borne infective
agents.

Cleanroom goggles with prescription lens inserts fitted

Cleanroom goggles used with the operator’s normal glasses Surgical mask

Cleanroom masks are chosen when it is necessary to Surgical masks have been adopted by cleanroom
protect the production environment from droplets of industries and are extensively used in highly controlled
saliva and mucus generated by the cleanroom staff. manufacturing environments because of their filtration
When a mask is required to protect the wearer from properties.
chemical or particulate inhalation hazards then the
correct PPE must be used. Masks are usually composed of several layers of non-
woven materials often polypropylene or polyester. The
Typically saliva contains 107 micro-organisms per layers may be moisture absorbent next to the mouth
millilitre and droplets are dispersed from the mouth and and nose so producing a more comfortable mask.
nose by sneezing, coughing or talking and each droplet
may contain hundreds of micro-organisms. These
droplets are relatively large in size with an average
diameter of approximately 50µm and will therefore
be readily deposited onto surfaces and not remain
suspended in the surrounding air. As these droplets are
large particles even the most basic masks have high
retention efficiencies of >95%.

53
Masks can be tested to show their effectiveness in
several ways;
• PFE (Particulate Filtration Efficiency) measures the
percentage efficiency at which the face mask filters
particulate matter.
• BFE (Bacterial Filtration Efficiency) measures the
percentage efficiency at which the face mask filters
out bacteria.
• Delta P (Delta pressure) is the pressure drop across a
facemask, the higher the Delta P the more difficult the
mask is to breathe through and the more likely it is that
breath will pass around the mask rather than through it.
• Tests for skin irritation and sensitisation can also be
carried out to ensure that the masks do not produce skin
problems when worn for long periods.

Masks must fully cover the nose and mouth and so a

mouldable metal nose band is incorporated into the
mask to allow the wearer to fold the mask into position
and produce an effective seal.
“Duck bill “mask worn with goggles and hood
Disposable masks are held in position by ear loops or
Blue or white masks are commonly selected but other
ties which fasten or clip behind the head.
colours are available.

Flat folded masks are regularly used however in many

Disposable cleanroom masks can be supplied in single
cleanrooms one of the key requirements is to ensure
or multiple packs and may be sterile or non-sterile.
that the mouth and lips do not contact the mask
material. If this happens, the mask may become wet and
Face veils provide an alternative to masks and are
is then more likely to tear, providing a direct pathway for
clipped or studded to the inside of a cleanroom hood.
contamination into the controlled area.
These veils are usually re-usable items but single use
disposable veils can be obtained if required.
To prevent this problem cone shaped or ‘duck bill’ masks
can be worn which stand clear of the wearer’s mouth.

5.4
Handwear

Gloves
Cleanroom gloves are a critical element of
contamination control. Most manufacturing operations
will require hand contact with equipment or materials
giving high potential for direct (primary) or secondary
contamination or cross-contamination of product.

54
 Cleanroom gloves in use.
Image courtesy of Photronics UK Ltd.

Cleanroom gloves must therefore provide an

effective protective barrier to stop skin particles and ESD cleanroom gloves. Image courtesy of Asiatic Fiber Corp
viable organisms from the hands contaminating the
cleanroom.
Re-usable gloves which can be cleaned and
A punctured glove provides a potential route of decontaminated are available however the great
microbial contamination and in critical operations majority of gloves used in controlled environments are
such as aseptic manipulations the commonly adopted single use disposable items.
measure to control this risk is for operating personnel to
wear two pairs of gloves ref 3. Materials
Disposable gloves for cleanroom use can be
Gloves must also be a comfortable fit for the wearer and manufactured from a range of materials with different
have good flexibility and sensitivity to allow precision properties.
operations to be carried out.
Latex is natural rubber which has very good stretch
In some instances the gloves will also have to act as and flexibility and is resistant to wear and tear. Protein
protection for the wearer and be classified as PPE allergens may be present however and these can cause
and for some drug manufacturing operations patient allergic reactions in sensitised individuals.
protection standards must also be addressed.

When control of electro-static discharge (ESD) is a key

element of contamination control then gloves must be
used which meet this requirement.

55
 PVC (Polyvinyl Chloride) gloves provide protection
against many water-soluble chemicals. PVC is resistant
to wear and tear but has limited stretch and flexibility.
No protein allergens are present.

Latex cleanroom glove

Nitrile rubber is a synthetic material manufactured from

various proprietary compounds; it is very similar to latex
and has good resistance to wear and tear. No protein
PVC cleanroom glove
allergens are present.

Butyl rubber gloves are air and water tight and can
provide wearer protection against strong acids. They
have limited stretch and flexibility.

Nitrile cleanroom glove Butyl cleanroom glove

56
Categories, standards and test methods
Contamination control requirements dictate that
cleanroom gloves must provide an effective barrier
against the viable and non-viable particles lost from the
hands. The gloves may also need to protect the wearer
from chemical or biological contaminants present in the
production environment and in addition the gloves may
have to comply with patient protection standards.
Various standards and test methods have been
developed to assess the performance and suitability of
different gloves for these different requirements.

The following terms are often used to identify different

glove characteristics.
Penetration - the passage of chemicals and micro- Automated glove leak testing machine
organisms through the glove.
Degradation - the rate of loss of glove integrity following Gloves to protect the wearer
chemical exposure. When gloves are required to protect the wearer and
are acting as personal protective equipment (PPE) it is
Diffusion, Permeation and Desorption - all describe the
necessary to select a suitable risk category of glove.
movement of molecules through the glove.
Acceptance quality limit (AQL) a statistically valid Three categories of gloves are identified according to
sampling procedure giving a numerical indication of the their design and the risks associated with the intended
conformance of a product batch tested for a particular use;
characteristic. The lower the AQL the higher the level of
• Category I gloves are identified as simple design with
conformance to the test pass limits.
minor risk which can be identified by the user and are
labelled with a CE mark only.
For pharmaceutical and the medical industries, this
is a particularly important parameter for glove leaks • Category II describes all gloves except those in category
or pin holing. Typically, surgeon’s gloves are supplied I or III. Labelled with a CE mark only.
with an AQL of 1.5%. The generally accepted method • Category III gloves are identified as complex design
of testing latex gloves for leaks is detailed in European and intended to protect the wearer from risk of serious
Standard, EN455 Part 1 ref 4. This test involves securing or fatal injury which may not be identified by the
the glove around the circumference of the bead to wearer in sufficient time. Category III gloves are labelled
hold it in an open position prior to filling with 1000ml with the CE-mark plus a four digit code of the relevant
of water and then observing for leaks. Some glove notified body.
manufacturers have purpose built testing machines
which automatically fill gloves that have been loaded
onto a moving carousel with the correct volume of
water and present them for inspection as the next glove
is filled with water. This is useful if a large quantity of
gloves are to be tested.

Category III glove marking

57
In addition gloves may also be classified under the Glove design and presentation
Medical Device Directive (MDD) as a Class 1 product There is a very large range of glove styles and
when patient safety requires this classification. presentations available.
Options include;
Two standards are commonly used to test cleanroom • Size range
gloves. • Handed or ambidextrous
• BS EN 420:2003 ref 5 Protective gloves. • Different cuff lengths
General requirements and test methods • Smooth or texture finish
This covers general factors such as sizing, dexterity and • Different colours
leachable proteins. • Powder free or powdered (not usually appropriate for
cleanroom use)
• BS EN 374:2003 ref 6 Protective gloves against
• Bulk packed or individually packed
chemicals and micro-organisms
• Sterile or non-sterile
Part 2 Determination of resistance to penetration
• Anti-static
Part 3 Determination of resistance to permeation
by chemicals

These tests include air and liquid leak tests and

chemical permeation tests and are used to determine
the effectiveness of category II and III gloves.

Tests may also be carried out using The Institute of

Environmental Sciences and Technology recommended
practice IEST-RP-CC005.3 ref 7 - Gloves and fingercots
used in cleanrooms and other controlled environments. Boxed ambidextrous disposable gloves
This describes procedures for testing and evaluating
gloves and finger cots for use in controlled
environments. Tests are provided for determining
cleanliness, physical and chemical integrity, and other
relevant properties. Guidelines are also provided to
assist users in the proper selection of gloves or finger
cots.

Whenever gloves are required as PPE e.g. for the

preparation of cytotoxic drugs, a Health and Safety
specialist must be involved in all aspects of risk
assessment, product evaluation and selection.

A variety of different glove packs

58
The final selection of the appropriate glove for a
specific application will depend on the contamination
control system, the cleanroom garment styles, gowning
technique, wearer comfort and safety.

Section 9.0 Planning, sourcing and optimising cleanroom

consumables supply provides advice on specifying and
selecting the correct glove to meet the requirements of
specific operations.

Oversleeves and finger cots

Oversleeves may be worn to give additional protection
to the lower arm and are a tube of material which is Disposable finger cots

elasticated at each end drawn over the cleanroom

garment sleeve. Finger cots are usually made from the same materials
as cleanroom gloves and provide primary or additional
protection for the fingertips.

5.5
Footwear

Most cleanroom footwear is re-usable. This includes

dedicated cleanroom clogs and shoes together with
woven fabric overboots and shoes which are cleaned
and decontaminated with other re-usable cleanroom
clothing.

Single use disposable overboots and overshoes are also

used and are manufactured using non-woven materials.
They are available in a range of sizes with different
Disposable oversleeve
fastenings and sole materials. They may be supplied
cleaned and decontaminated, sterile or non-sterile with
Oversleeves may be produced in a variety of non woven various packing options.
or plastic materials and are often used to protect the
inner re-usable garment from significant permanent Lightweight plastic disposable overshoes are often
staining, to stop moisture penetration or provide required and these are usually manufactured from basic
chemical protection. cross linked polyethylene (CPE).

Where there is a heat risk non-flammable oversleeves They are normally blue, bulk packed, non-sterile and are
may be used to protect the wearer. not decontaminated after manufacture.

59
 Disposable plastic overshoes

Plastic overshoes are available in different thicknesses

of material and the lighter 4.5g/m2 shoes are only
suitable for short periods of use e.g. as a changing area
shoe cover.

If more prolonged use is required then the heavier

8.0g/m2 weight is needed to withstand wear without
perforating.

Operator slipping, particularly on smooth or wet

cleanroom surfaces can be an issue with this type of
footwear and needs to be carefully considered.

Disposable overshoes which incorporate an ESD

tape can be selected when control of static electrical
discharge is important.

Disposable cleanroom socks are also available and can

incorporate anti-bacterial and ESD properties.

ESD cleanroom sock. Image courtesy of Asiatic Fiber Corp

60
 SECTION

6.0
Decontamination of Cleanroom Garments and Consumables

6.1
Purpose and Function

Most cleanroom manufacturing operations require The clothing will usually have disposable elements such
staff to be present in controlled areas. The staff will as gloves and masks but the majority of the clothing
undertake a variety of tasks and may be working in will be reusable as these garments provide the most
cleanrooms with a wide range of classifications. efficient, cost-effective and environmentally friendly
option.
As part of the contamination control systems, staff
will be equipped with cleanroom clothing which is
suitable for the task and for the contamination control
requirements.

Contamination control clothing

61
Cleanroom clothing (and other textile items) are Various non-clothing items such as equipment covers,
manufactured from fabrics which act as a filter for the cleanroom mops and cleanroom wipes may also be
wearer and do not themselves produce significant required and these too will require processing by a
contaminants. (This is discussed in detail in Section 4.0 cleanroom decontamination process.
Reusable Contamination Control Clothing).

Once the garments have been worn however, the

clothing becomes contaminated by fibres, particulate
and micro-organisms which have been shed by the
wearer and which become trapped by the fabric,
especially on the garment inner surface.

Decontaminated cleanroom mop

Photomicrograph of fibre and particulate contamination on The cleanroom decontamination plant is responsible
cleanroom garment for the supply of these key services to the cleanroom
manufacturing operations.
Cleanroom clothing may also be contaminated during
use by materials from within the production area. These
contaminants may be powders or liquids and are usually
present on the outside of the garment.

Cleanroom decontamination plant

The six major stages listed below summarise the key

Photomicrograph of powder contamination on cleanroom garment
elements of cleanroom garment and consumables
For the cleanroom to operate efficiently staff must decontamination operations and although only clothing
have easy access to clean, decontaminated cleanroom is discussed the same approach is applicable for all
garments which are fit-for-purpose and presented in a other processed items.
way which allows changing procedures to be followed
effectively.

62
1 .Cleaning 6. Process control systems
The removal of soiling and stains to provide visually Use of control systems and associated monitoring
clean, dry, odourless garments. methods for all critical aspects of the cleanroom
decontamination process to ensure consistency of
2. Disinfection and sterilisation process and product quality.
The production of cleanroom garments with a very low
bio-burden and the addition of a further sterilisation
6.2
treatment when sterile clothing is required.
Cleanroom Garment and Consumables
Decontamination Plant - Layout and
3. Particulate decontamination
Contamination Control Requirements
The removal of particulate and fibre contamination from
the garments to leave only a very small residual number
Diagram 1 shows the basic elements of a cleanroom
of particles and fibres.
decontamination plant, and the general material flow.

4. Checking and inspection

The facility will have a dedicated entrance for personnel
Comprehensive inspection and checking of every
where staff will change into cleanroom clothing that is
item to ensure that there is no damage which would
consistent with the cleanroom cleanliness classification
subsequently compromise the contamination control
level, prior to entry into the processing cleanroom.
systems.
The garment processing cleanroom will be at a higher
differential pressure than the adjacent staff changing
5. Packing, labelling and presentation
and secondary packaging area. This helps to prevent the
Folding, labelling and packaging of the garments
ingress of both viable and non-viable particulate from
following processing.
these areas. The cleanliness classification level of the
cleanroom will be determined by the requirements of
the materials being processed in the cleanroom.

STAGE 4
Transfer Staff
Hatch changing and
access

Garment
Processing STAGE 3
Cleanroom
Secondary
Packaging and
Despatch Area STAGE 2

Staff
changing and
access
Cleanroom
Staff Dryer
changing and
access Barrier
Washer
Extractor

STAGE 1

Diagram 1. Plan of typical decontamination plant

63
The secondary packing area is likely to be of a less
stringent classification due to the nature of the activities
undertaken in it.

Stage 1.
Contaminated items are loaded into a barrier washer-
extractor unit from a non cleanroom area. When
the cycle has been successfully completed, the
decontaminated load is unloaded into the cleanroom
area.

Barrier washer-extractor machines are designed to wash

and centrifuge items held within a rotating drum. The
entry and exit doors are interlocked so that only one
door can be opened at a time and the exit door remains
locked until the decontamination cycle has been
successfully completed. The washer-extractor therefore
acts as a pass-through barrier in the cleanroom wall
allowing soiled items to be placed within the machine
on the outside and clean, disinfected items to be Barrier washer extractor machines incorporated into the cleanroom
removed from the machine directly from inside the wall to act as a pass-through barrier into the processing cleanroom

processing cleanroom.
Stage 2.
The decontaminated garments are then loaded into the
cleanroom dryer from the cleanroom. The dryer has the
same cleanliness levels as the processing cleanroom in
which it is sited.

Drying of the processed items in this unit is achieved

with hot, filtered air; the hot airstream enters the unit
via an appropriate grade of filter and is exhausted to
atmosphere out of the cleanroom.

This filtered airflow prevents recontamination of the

load and also helps to remove any remaining particles
and fibres during the drying operation.

Barrier washer extractor exit (unloading) door

64
Items for use in high grade cleanrooms are usually dried Stage 3.
using a tumble dryer. The decontaminated and dry garments are unloaded
into the processing cleanroom where they will
be inspected, folded, packed and sealed into an
appropriate primary protective wrapper.

Cleanroom clothing being folded ready for packaging

Cleanroom tumble dryer in operation

Garments for use in lower grade cleanroom areas may

be dried using a tunnel finisher. In this type of process
garments are placed on hangers and pass through a
chamber which is supplied with hot, filtered air.

Decontaminated cleanroom garment in primary packaging

Tunnel finisher Stage 4.

The primarily protected items are then transferred
into a less controlled area, normally connected to
the cleanroom by an air-lock pass-through hatch, for
secondary packaging and assembly for delivery to the
customer.

65
 To meet different contamination control requirements
various classifications of cleanroom decontamination
plant are available, however as each cleanroom
operation is unique it is not always possible to exactly
match the production area cleanliness classifications
with those of a decontamination plant.

A professional cleanroom decontamination plant

operator will be able to offer a range of processing
options and will work closely with the end user to agree
the most technically appropriate and cost effective
service.

Any decontamination plant must be validated and

Fully processed and packed items for despatch
monitored to confirm the cleanliness classification level.
ISO standard 14644-1 ref 1 defines the various
Cleanroom decontamination plant classification cleanroom cleanliness levels, the lower the ISO
Each cleanroom manufacturing operation will specify classification number, the more stringent the cleanliness
a clothing policy and cleanliness levels appropriate for level. The ISO cleanliness classifications, measured
their contamination control plan. by particulate monitoring within the cleanroom, can
be stated either when the cleanroom is not occupied
As the cleanroom cleanliness levels become more (at rest) or when it is occupied and functioning (in
stringent, so do the operating costs and it is clearly use). The cleanroom staff and activity associated with
inefficient to use cleanroom clothing and consumables production will produce particulates and so the in use
which have been processed through a high grade ISO classification will normally be higher than the at rest
cleanroom decontamination plant in a low grade ISO classification for the same room.
manufacturing area. Conversely it would be completely
unacceptable to provide items for use in a high grade Diagram 2 shows the ISO classifications (at rest)
environment that have been decontaminated in a low which would be required for a decontamination plant
grade cleanroom. producing products for use in a range of high grade
cleanrooms.

Staff
changing and
access
Garment
Transfer
Processing
Hatch
Cleanroom ISO
CLASS 5

ISO CLASS 6 ISO CLASS 4

Secondary
Packaging and
Despatch Area Staff
changing and
access
Cleanroom
Staff Dryer
changing and
access Barrier
Washer
Extractor
All classifications shown are for unmanned (at rest) conditions

Diagram 2. Example cleanroom garment and consumables decontamination plant cleanliness classifications

66
Diagrams 3, 4 and 5 show examples of operational, The garment particulate classifications normally
(in use) classifications for different garment and achieved by these grades of processing facility are also
consumables decontamination plants together with shown.
examples of the types of manufacturing operations
they could supply. The GMP EU grades ref 2 shown are (Section 2.0 Cleanroom Classifications and Standards
obtained by monitoring the microbiological levels provides more detailed information on the relevant
within the cleanroom during use. standards).

Staff
changing and
access

Transfer Garment GMP GRADE

Hatch Processing
Cleanroom
B
Minimum ISO
Class 7

GMP GRADE C GMP GRADE B

Minimum ISO Class 8 Minimum ISO Class 7
Secondary
Packaging and
Despatch Area Staff
changing and
access
Cleanroom
Staff Dryer
changing and
access Barrier
Washer
Extractor
All classifications shown are for operational (in use) conditions

Diagram 3. Example cleanroom garment and consumables decontamination plant cleanliness classifications

The decontamination plant classifications shown This would include aseptic manufacture, vaccine
in diagram 3 would be suitable for processing production, blood products and other biological
cleanroom garments and equipment for use in high preparations.
grade Bioscience and Pharmaceutical manufacturing
operations where control of viable microbiological The garment particulate and fibre classification
contaminants is paramount. following processing and packaging in this environment
would be IEST-RP-CC003 ref 3 class I and ASTM
F51/00 ref 4 Class A.

67
 Staff
changing and
access

Transfer Garment
Processing
Hatch
Cleanroom CONTROLLED
AREA

CONTROLLED GMP EU GRADE C

AREA Minimum ISO Class 8
Secondary
Packaging and
Despatch Area Staff
changing and
access
Cleanroom
Staff Dryer
changing and
access Barrier
Washer
Extractor
All classifications shown are for operational (in use) conditions

Diagram 4. Example cleanroom garment and consumables decontamination plant cleanliness classifications

The cleanroom classifications shown in diagram 4 would For non-biological manufacturing this grade of
be suitable for the processing of cleanroom clothing cleanroom decontamination plant would be suitable
and equipment for use in the outer areas of high grade for electronic circuitry and optical products production,
Bioscience and Pharmaceutical cleanrooms and for surface finishing and high care food manufacturing
cleanroom undergarments. facilities.

It would also be appropriate for clothing used in barrier The garment particulate and fibre classification
isolator manufacturing, tabletting operations, basic following processing and packaging in this environment
wound care and medical device production. would be IEST-RP-CC003 ref 3 class II or III and ASTM
F51/00 ref 4 Class B or C.

Staff
changing and
access

Transfer Garment
Hatch Processing
Cleanroom
ISO
CLASS 6

ISO CLASS 7 ISO CLASS 5

Secondary
Packaging and
Despatch Area Staff
changing and
access
Cleanroom
Staff Dryer
changing and
access Barrier
Washer
Extractor
All classifications shown are for operational (in use) conditions

Diagram 5. Example cleanroom garment and consumables decontamination plant cleanliness classifications

68
The cleanroom classifications shown in diagram 5 would For a low grade cleanroom decontamination operation
be suitable for the processing of cleanroom clothing potable water is used, for high grade processing
and equipment for use in high grade micro-electronics however, the water quality is usually improved e.g. by
manufacturing and precision engineering with strong filtration or reverse osmosis (RO), to ensure a consistent
emphasis on the control of fine particulate, chemicals and low bio-burden with low dissolved solids.
and ESD.
Water based processes may be used for the removal of
Examples of operations which would utilise this type of all types of soiling and different cleaning requirements
cleanroom decontamination plant are waferfab plants, are addressed by selecting the appropriate chemicals,
microelectronics assembly, critical space engineering, washing machine action, temperature and process time.
optical engineering and weapons manufacture. By varying these parameters it is possible to remove
soiling and reduce most staining to an acceptable level;
The garment particulate and fibre classification however some materials, such as indelible printing ink,
following processing and packaging in this environment may be difficult to remove.
would be IEST-RP-CC003 ref 3 class I and ASTM
F51/00 ref 4 Class A. Following cleaning the items are dried using either
a tumble dryer or tunnel finisher. Tumble dryers are
used in high grade cleanroom decontamination with
6.3 measured loads of damp items being mechanically
Cleanroom Decontamination Plant tumbled in hot filtered air.
Cleaning Process
The cleaning process used by the decontamination The tumble drier is kept under positive pressure and
plant is designed to remove visible stains, odours and fed with heated, filtered air which is exhausted to
other contaminants so that the garment is returned to atmosphere after passing through the machine.
the wearer in a visually clean and dry condition.
Garments used in high grade cleanroom manufacturing A tunnel dryer operates by passing hanging garments
are not usually subjected to significant soiling or continuously through a hot air chamber fed with heated,
wear but for some operations such as medical device filtered air, exhausted to atmosphere and this type of
manufacture, tablet production and surface finishing, drying may be used for processing low grade cleanroom
cleanroom garments may become soiled with a range of garments.
contaminants including ink, paint, powders and sealants.

If it is suspected that items for decontamination could

be contaminated with harmful materials then the 6.4
cleanroom decontamination plant must be informed Disinfection and Sterilisation
prior to garment handling and processing.
General principles
Soiling may be removed using either a solvent (dry- Simple definitions of the terms disinfection (sanitisation)
clean) or wet-wash (water based) process. and sterilisation are;
• Disinfection; to clean in order to destroy or prevent the
Solvent processes may be used for the removal of growth of disease-carrying micro-organisms.
paints, heavy oil and grease; however the solvent • Sterilisation; the procedure of making some object free
systems used pose a variety of particulate, chemical, of live bacteria or other micro-organisms.
microbiological, safety and environmental problems
and so are rarely used for cleanroom product
decontamination. Water based methods are therefore
the usual choice for cleanroom product cleaning.

69
The cleaning process used by the decontamination Effective cleaning can be achieved at low temperature
plant removes and kills micro-organisms. The using modern wash chemicals and most domestic
mechanical action of the washer extractor, together with washing machines operate at 30ºC to 40ºC however
the use of process chemicals, physically removes and this low temperature does not achieve disinfection and
suspends micro-organisms, many of which are damaged higher temperatures are required.
or killed by chemical action.
Guidance for the thermal disinfection of textiles
Part of the cleaning cycle is very likely to be at high has been provided in the UK by the Department of
temperature which will kill or damage most vegetative Health publication HSG (95)18 ref 5: Hospital laundry
microbes. arrangements for used and infected linen, which
stipulates that consistent and acceptable disinfection
The subsequent drying process further reduces can be achieved if the temperature of the wash load is
the small number of surviving micro-organisms by held at 65ºC for 10 minutes or 71ºC for 3 minutes and
desiccation and so the process greatly reduces the this has become accepted practice for the disinfection
number and type of microbes (the bioburden) on the of textiles.
cleaned item.
Fungal and bacterial spores are not killed by these
All processing takes place in a controlled cleanroom temperatures however.
environment and this ensures that the chance of
re-contamination of the product by staff or from the Use of a high water-temperature as a disinfecting stage
environment is reduced to a minimum. has several advantages.

Items cleaned, dried and packed by a cleanroom Water can be easily heated by a variety of means
decontamination plant will therefore be effectively which do not contaminate the water with particulate or
disinfected and have a very low bioburden. chemicals.

Thermal disinfection Water temperature can be easily monitored using

During the Victorian era heat was recognised as the simple and easily validated temperature sensors and
main method for textile disinfection and ‘Steam Laundry’ software.
employed boiling for all items.
The mechanical action of the washing machine gives
rapid and consistent mixing of the contents.
Any textile items submerged in the water are quickly
raised to the water temperature evenly across all
contact surfaces.

The high wash temperature increases soil removal and

cleaning, reducing the requirement for chemicals.

Drying
To achieve drying the textile item is raised to a minimum
of 100ºC and the majority of residual vegetative
organisms, but not fungal or bacterial spores, will be
killed by desiccation during this process.

Victorian steam laundry

70
Cleanroom handling and packing Disinfection can be achieved at low temperature using
Once items have passed through the disinfection stages ozone wash systems which saturate the process water
all further processes are designed to minimise the with highly oxidizing ozone (O3) molecules.
possibility of recontamination of product by the staff, Small purpose-built washing machines are available
from the production environment or process equipment. which incorporate ozone injection systems with good
All items are therefore handled, sorted and sealed reported results. In full size cleanroom washer extractors
in primary packaging within the main manufacturing however producing and maintaining adequate levels
cleanroom before being transferred to dispatch areas. of ozone throughout the wash load is very difficult
to achieve and monitor. This technology is therefore
Disinfection Process Summary currently not considered to be reliable for large scale
Production of cleanroom garments and consumables cleanroom decontamination plant use.
with a consistent and very low bioburden therefore has
several interlinked process stages; Sterilisation
• Mechanical removal or damage to micro-organisms by Gamma irradiation
the wash process. For some high grade bio-medical and pharmaceutical
manufacturing procedures a further sterilisation process
• Destruction or damage to micro-organisms by the
is required for garments or consumables following
process chemicals.
production and packing by the decontamination plant.
• Thermal disinfection from high temperature wash.
A sterile product is accurately defined as an item with
• Use of biologically controlled process water to prevent
a sterility assurance level (SAL) of 10-6. This means that
re-contamination.
there is a theoretical chance that if 1 million organisms
• Desiccation of micro-organisms during drying. were present on the product before the sterilisation
• Cleanroom processing of disinfected items to prevent process, 1 viable organism could remain after the
re-contamination. process.
• Cleanroom application of sealed protective packaging
to prevent re-contamination. Cleanroom processed items presented for sterilisation
by the decontamination plant will have only a very few
Non-thermal disinfection methods organisms present which means that effectively no
Chemical biocides may be added to the wash cycle. The viable organisms (including fungal and bacterial spores)
correct dilution and distribution throughout the entire remain after sterilisation.
wash load together with an adequate contact time is
necessary to achieve satisfactory disinfection of all Sterility is usually achieved for textile items by gamma
items being treated. These parameters are more difficult irradiation using a minimum irradiation dose of 25kGy.
to control and monitor within the washer extractor than
temperature and it is therefore difficult to easily confirm
effective disinfection of each item within each load.

Residual biocide may be retained on the fabric surface

and give additional antimicrobial benefit during use.
However residual chemical on the clothing may pose a
contamination risk to wearers (especially on garments
in contact with the skin), to the cleanroom environment
and to the products being manufactured. Gamma irradiation

Chemical disinfection is usually only used therefore

when materials will be damaged by thermal disinfection
temperatures e.g. laminated fabrics.

71
The process is highly automated and controlled ref 6 Autoclave
with annual dose validations proving the effectiveness Autoclaving uses pressurised steam to sterilise items
of the process for each product type. Additionally packed within a chamber, typically at a temperature
each sterilisation batch is monitored to measure the of 121ºC. To be effective the steam must contact all
gamma dose throughout the product and a certificate surfaces to be sterilised and so steam permeable
of irradiation is issued to confirm that the minimum packaging is needed for any bagged items. The time
gamma dose has been received. Detex labels, which required for sterilisation will vary with the product
change colour from yellow to red on exposure to type and loading density and is usually validated using
ionising radiation, are often applied to products and physical, chemical or biological sterility indicators
provide a quick visual confirmation of sterilisation. placed within the load.

Irradiated and unirradiated detex labels

Sterilisation is usually carried out by a specialist sub- Industrial autoclave. Image courtesy of Baxter Healthcare Ltd
contractor employed by the decontamination plant.
Gamma sterilisation is an effective method for
This method of sterilisation is often used when
producing sterile textile products for cleanroom use
cleanroom garments must be sterilised after use, and
however the process physically damages fabrics over a
before transport to the garment decontamination plant,
prolonged period and will reduce the useful life of the
in order to control a biological hazard e.g. when the
sterilised products.
clothing has been used in a virus culture area in vaccine
manufacture.

Steam sterilisation causes heat-set creasing in polyester

fabrics and shortens garment life.

Cleanroom fabric showing discolouration following repeated

decontamination and gamma irradiation sterilisation cycles

72
6.5
Particulate and Fibre Decontamination

The decontamination plant must remove fibres and

fine particulate from the processed items in addition to
achieving visual cleanliness and disinfection.

Low shedding cleanroom fabrics are used to reduce

the number of particles and fibres being produced by
the items themselves and so the main requirement for
the decontamination plant is to remove contamination
which has been deposited on the surface during
manufacture or use.

Photomicrograph of decontaminated cleanroom garment

Following the drying stage the clean, dry,

decontaminated items are packed within a
cleanroom environment in non-shedding packaging
to again reduce any risk of particulate and fibre re-
contamination.

Confirmatory checks are carried out to show that the

decontaminated items have achieved the particulate
cleanliness level required. These will usually be either
the Helmke drum test as detailed in IEST-RP-CC003.3 ref 3
or the ASTM F51/00 ref 4 microscopic test. (See Section
Photomicrograph of contamination on a cleanroom garment
following use 2.0 Cleanroom Classifications and Standards for further
details).
A cleanroom decontamination cycle will remove
contaminants as part of the cleaning process and
particles and fibres of all types will be removed during
the wash cycle. Use of purified water reduces the
possibility of re-deposition of particulate onto the
processed items.

After the washing stage all operations are carried out in

a controlled cleanroom, again reducing the possibility of
recontamination.

The final stage of particulate removal occurs during

drying when the processed items are agitated in a fast
flowing stream of heated, filtered air.

Particulate adhering to the fabric surface is lost as the

fabric dries and is carried away by the airflow.

73
1 2

3 4 5

Sequence of photos showing ASTM F51/00 particulate and fibre test.

1. Preparing the equipment. 2. Placing the test garment on the test frame. 3. Taking a vacuum sample onto a filter. 4. Fibre counting.
5. Particle counting.

74
6.6
Product Inspection and Conformance Checks When ESD control is a key requirement then standard
electrical conductivity tests ref 7 are required to confirm
The physical integrity of fabric items is a critical aspect that fabric and garment conductivity are still functioning
of contamination control. at the required level.

Damaged mops, wipes or equipment covers can shed

large numbers of particles and fibres and damaged
cleanroom clothing may also allow the escape of
particulate from the wearer.

The ESD (electro-static discharge) properties may also

deteriorate and this can cause damage to products by
static discharge.

For all decontaminated items it is therefore necessary

to have clear and comprehensive inspection and test
procedures to ensure that all products are suitable for
purpose.

Visual inspection is carried out to detect physical

damage such as holes or tears. Checks are also required
on fixtures and fittings such as zips, studs and tapes, the
sole material of boots and shoes must be checked for
damage or cracks.

For re-cycled items, such as cleanroom clothing, the

fabric must be inspected to check that it has not ESD garment test

deteriorated significantly and remains in an effective

and acceptable condition. Fabric wear is influenced by many factors including the
type of manufacturing operation in which it is used, the
number of decontamination processes received and any
sterilisation cycles.

This variability means that as well as a visual inspection

it is often necessary to validate an acceptable garment
life for a particular process and to remove the item at
the pre-determined maximum number of wear and
process cycles regardless of its physical appearance.

If an item fails to achieve the minimum standard set

by the various conformance procedures it must be
removed from cleanroom use and either repaired or
Inspection of garments for physical damage replaced.

75
6.7
Labelling, Packaging and Presentation

Single use items such as wipes or disposable garments

are not usually individually marked and product
packaging provides all relevant information.

Garment barcode

Information gathered in this way can be managed in

a database to provide information such as location,
Fully labelled cleanroom wipes number of process cycles and number of sterilisation
cycles.
Reusable items which undergo repeated use and
cleanroom decontamination cycles are individually In order to identify the item visually, printed labels are
labelled. produced which may be sewn onto the fabric or sealed
on with adhesive.
Labelling of cleanroom items is required for various
purposes; Direct printing onto the fabric can be achieved using
sublimatic ink transfer and this allows the application of
• To individually identify the item.
any design or colour and is especially effective for the
• To track the location of the item.
application of corporate logos or to provide information
• To monitor the process count of re-cycled items.
such as department of use.
• To provide process and expiry date information.
• To visually identify sterilised items.
• To identify items with user-specific information.
• To meet corporate identity requirements.

Each individual item is identified with either a barcode

or a transponder which can be read at any point by a
suitable electronic reader.

Garment transponder Examples of sublimatic printing on cleanroom garment

76
Process labels, such as process batch number, expiry
date and sterilisation indicator labels (detex labels),
are normally applied to the primary packaging and are
clearly visible at the final point of use.

Packaging and presentation

The packaging and presentation of cleanroom
decontaminated products is dependent on the type of
product and the cleanroom in which it will be used.

Primary packaging is product specific, for example;

1. Sterile alcohol-impregnated cleanroom wipes require
primary packaging which will completely contain the
alcohol impregnant and be physically strong enough
to contain the wipes but also allow easy access to
the contents. It must remain unchanged by gamma
irradiation or VHP gassing, be effectively cleaned by
wiping and readily accept product labels.

2. Cleanroom clothing for low classification areas requires

Packed cleanroom mop
primary packaging which will contain the garment
and provide a protective barrier to prevent re-
contamination. It may need to be cleaned by wiping
with alcohol and will need to accept process labels. The
material needs to be transparent to allow the clothing
and its labels to be visible to the wearer and must be
easy to open.

Packed cleanroom garment

Secondary packaging consists of additional layers which

Packed cleanroom wipes can be removed in stages when the product is being
used and for high grade cleanroom operations up to 4
packaging layers may be required.

Presentation of cleanroom clothing and consumable

products can also be tailored to individual needs. For
example specific folding of garments may be needed
to match prescribed and validated gowning procedures
or a variation on the number and type of packaged
cleanroom wipes or mops may be requested by the end
user.

77
6.8
Process Monitoring, Controls and Records Alarm states will be set for all critical stages and failure
to meet the specified parameter will result in an
The cleanroom decontamination plant provides a critical immediate alarm and automatic halt of the process.
service to manufacturing operations. Failure of correct All key data, including any out of specification alarms,
garment supply can lead to shut-down of the operation will be captured and stored for future reference.
or contamination of the product resulting in serious
financial loss.

When patient safety is a risk then the potential for harm

caused through a contamination control failure is even
higher.

For this reason the decontamination plant must be

monitored and controlled to provide evidence and
assurance that all operations are robust and products
within specification. This is usually accomplished within
the framework of a recognised and accredited QMS
(quality management system).

Monitoring and control systems are broadly based

SCADA process monitoring
around two operational areas;
1. Process and engineering controls
Cleanroom and product controls
2. Cleanroom and product controls
Testing is required to ensure that the decontamination
plant cleanroom is operating effectively and within
Process and engineering controls
specification.
Cleanroom decontamination operations require the use
of industrial processing machinery and purified water
The unmanned (at rest) cleanroom will be tested and
systems.
validated on a regular basis by validation engineers
using the methodology specified in ISO 14644 ref 1.
These machines require regular maintenance to provide
uninterrupted and consistent operation and a planned
Further particulate monitoring will be carried out during
preventative maintenance (PPM) schedule is required
decontamination operations to give an indication of the
with accurate PPM records retained for reference.
contamination levels present during operational (in use)
conditions.
The wash and dry cycles are critical process points
providing cleaning, disinfection, particle removal
Pressure monitors will be in place to continuously
and drying. Control, monitoring and batch process
monitor and record cleanroom overpressure.
information are therefore required for these stages.

SCADA (supervisory control and data acquisition)

systems are used to achieve this degree of control and
data collection.

The SCADA system will monitor critical parameters such

as wash temperature, process time and conductivity.
The drying cycle will also be monitored and the SCADA
system can be used to adjust the process time according
to the moisture content of each load.

78
 The purified water system will also be monitored for its
physical characteristics and microbiological loading.

Particulate and fibre tests will be carried out on

sample processed textiles to confirm acceptable
decontamination of products using either the Helmke
drum test, IEST-RP-CC003.3 ref 3 or the ASTM F51/00 ref 4
microscopic test.

When an additional sterilisation stage is required the

process will be validated, monitored and certified by the
sterilisation contractor. Microbiological sterility testing
may also be carried out on finished product to confirm
that the process is effective.

Cleanroom decontamination plant operations will be

controlled by a documented system covering all aspects
of the process.
Cleanroom pressure monitoring

This will include all critical areas such as staff training,

If control of viable particles is required then the
changing procedures, access controls, cleaning
decontamination plant cleanroom will be monitored
procedures, records, validation and change control.
during use for microbiological contaminants and
the test methods recommended in the MHRA Rules
Records
and Guidance for Pharmaceutical Manufacturers and
Monitoring and control systems operated by the
Distributors ref 2 are usually adopted.
decontamination plant produce a variety of results and
records. These results are used to provide confirmation
that the plant is producing products which meet the
agreed specification and are suitable for cleanroom
use. The records are also available for inspection
during investigations, for example if there is a potential
contamination issue either at the decontamination plant
or the end user.

Microbiological testing

79
6.9 6.10
Cleanroom Decontamination Plant Audits Special Customer Requirements

Customers for decontaminated products will audit their Cleanroom decontaminated garments and consumables
key cleanroom suppliers, including decontamination are used in a wide variety of manufacturing operations.
facilities, to ensure that the services provided meet Each manufacturer will use the principles of
the needs of their contamination control systems and contamination control to protect their product but each
regulatory requirements. location and process will have different requirements.

The exact format of these audits will depend on the Cleanroom decontamination plants offer a range of
organisation involved but a minimum audit checklist will standard products which are designed to meet the
include the following; majority of customer needs, however, if a particular
1. Profile and organisational structure of the clothing operation requires a unique product or service the
and consumables decontamination company. cleanroom decontamination plant will be able to work
with the customer to develop the best and most cost-
2. Cleanroom design, layout, classifications and
effective solution.
validation.
3. Water systems and water specifications.
4. Product and people flow.
5. Process controls and monitoring.
6. Batch records.
7. Quality Management System (QMS) including
accreditations, document control, standard operating
procedures, deviation reporting and investigation,
change control, validation.
8. Staff training and training records.
9. Garment particulate testing and results.
Cleanroom production of wipes
10. Microbiological monitoring programme and results.
11. Calibration and records.
Examples of special products and services are;
12. Engineering maintenance.
1. The cleaning and decontamination of medical
13. Disaster recovery plans. device components.
2. Packing and sterilisation of equipment packs.
When sterile products are required then the sterilisation
process will also need to be audited. 3. Specific impregnants on wipes and mops.
4. User specific garment design.
Audits are an essential element of contamination 5. Machine and equipment covers.
control and also provide an excellent forum for the
6. Unusual fabric requirements.
exchange of ideas and information of benefit to both
customer and supplier. 7. Additional microbiological or particulate testing.
8. Special validation exercises.

In addition new fabrics, products and processes are

being continuously developed by the cleanroom
garment and consumables decontamination industry
to match the expanding global use of cleanroom
technology.

80
Compliance 100® Micronclean syringes

81
 SECTION

7.0
Cleanroom Cleaning - Methods and Equipment

Sections 7.1, 7.2 and 7.3 discuss the reasons for The smaller particles may be more widely dispersed
cleaning and the basic elements of a cleaning system. before similarly settling onto cleanroom surfaces. Static
The later sections give further details of cleaning electrical charges generated by cleanroom equipment
products, methods and materials. and activities will also increase attraction and adhesion
of fine particulate.

7.1 Staff access to the cleanrooms will be through changing

Contamination Control and the Requirement areas and these locations will become contaminated
for Cleaning during gowning procedures. Contamination may also be
transferred between areas with floors being particularly
A large amount of time, energy and money is usually vulnerable as dirt can be transferred into a cleanroom
expended on the design and development of by foot.
contamination control facilities.
Re-usable cleanroom garments are extensively
Once the cleanroom is operational an equal emphasis is packaged to protect the garments from contamination
required to establish and maintain consistent ongoing during transport and storage, the outer layers of
control and the cleaning system is a key element of this packaging will become contaminated and the opening
process. and removal of packaging and the packaging material
itself all produce contamination.
Cleaning can sometimes be regarded as a secondary
function and may also be seen as an easy target for Removal and disposal of cleanroom clothing will also
cost reduction exercises. However without an efficient generate significant particulate.
cleaning programme the whole cleanroom facility is at
real risk of failure as contamination can quickly build up Transfer of equipment and materials into the cleanroom
and be transferred to the product. will be strictly controlled but the transfer operation,
including removal of packaging, will also produce
The cleanroom air filtration system effectively controls contamination.
the ingress of airborne fibres and particulate into the
cleanroom, however this does not mean that the area As part of the production process staff will be required
will remain free from contamination during use. Both to operate equipment and handle different materials.
the cleanroom staff and the production process will Touching and contacting may contaminate gloves and
introduce a range of contaminants during manufacturing other surfaces on the cleanroom gowns and may create
operations. a cross-contamination risk to other items and work
surfaces.
Cleanroom clothing is low shedding and acts to filter
the viable and non-viable particulate being lost by The production machinery and process may also
the wearer. Although very effective in greatly reducing produce fibres and particulate and some operations
the contamination from staff not all fibres or particles may produce vapour or droplets which can be
are contained within the garments and a significant deposited onto surfaces leaving contaminating residues.
amount of contamination will still be dispersed into the
cleanroom by the occupants and their clothing.
Many of the larger particles will settle by gravity onto
horizontal surfaces in the cleanroom.

82
A fully-operational cleanroom may therefore become Microscopic contaminants, containing both viable and
contaminated by a range of materials. non-viable particles range from approximately 50µm
down to <1µm in size and are affected much less by
These can be usefully considered as either large visible gravity. This material will be deposited on horizontal
contaminants such as discarded packaging or visible surfaces but will also become attached to walls, ceilings
liquid droplets, or as microscopic particulates and fibres and equipment. The cleanroom airflow (vertical or
of approximately 50µm or less which are not visible in horizontal unidirectional airflow or turbulent flow) will
normal light. also affect the distribution and deposition of these
particulates.
When the concentrations of such small particles
build up and become visible the cleanroom surface All surfaces in a cleanroom should be as smooth as
cleanliness levels have been grossly violated. For possible with minimal sharp corners as rough surfaces
cleanrooms utilised by the healthcare industry, the and inaccessible angles are more likely to hold fine
cleanroom surfaces must also be disinfected to kill any particles making them difficult to remove.
viable contamination that may be present.
Microscopic particles and fibres on cleanroom surfaces
Removal of visible contamination requires good may be attached by physical, chemical and electrical
housekeeping and effective basic cleaning techniques. forces the main force being the physical intermolecular
Removal of microscopic contamination is achieved force known as London-van der Waals. Particles of this
using specialised cleanroom cleaning materials and small size cannot be removed by dry vacuum cleaning
procedures. as this method has insufficient energy to overcome
these adhesive forces.

This material must be dislodged by direct physical

7.2 contact and this is usually achieved by mopping or
Cleanroom Cleaning - General Considerations wiping. The material from which these mopping or
wiping products are made will affect their particle
Visible contaminants in the cleanroom can be controlled
removal efficiency - the greater the contact area the
by basic cleaning and housekeeping methods.
better the removal effect.

Very large contaminants such as discarded packaging or

Particle removal is significantly improved if a liquid
cleanroom disposables can be placed in a disposal bag
is used to aid the process which allows some of the
and carried from the area. Disposal containers should be
particle to surface bonding to be broken. Suitable
placed in areas where they can be frequently emptied.
cleaning liquids not only increase the physical removal
Reusable cleanroom clothing can be removed and
efficiency but may also dissolve or suspend the
placed in designated containers for collection and
contaminants.
reprocessing. These containers should not be large
enough to allow several days of discarded items to
Water, surfactants or solvents may all be used in this
accumulate and should be emptied using a technique
way to dampen wipes and mops and improve particle
which minimises dispersion of particulate into
removal. Wet cleanroom compatible vacuum cleaning,
controlled areas.
which is more efficient than a dry vacuum system, may
also be employed for appropriate surfaces such as large
Large visible particulates and fibres are quickly
floors.
deposited by gravity and so are normally found
on horizontal surfaces. This material can be readily
Water used for cleaning or chemical dilution should
removed using cleanroom compatible vacuum cleaning,
be at a purity which is acceptable in the area being
the material being lifted from the surface by the airflow
cleaned and must not be a source of micro-organisms or
and collected for disposal.
chemical residues.

83
In any cleanroom cleaning programme it is therefore The cleaning methods and materials chosen must help
necessary to first remove the visible contamination to minimise product contamination and at the same
before the removal of the microscopic contamination. time not themselves produce any damaging effects or
The removal of visible contamination is sometimes residues.
referred to as “cleaning” and the subsequent removal of
microscopic particles as “decontamination” and this can Cleanliness classification
be a helpful distinction during staff training. The established cleanliness classifications for each area
will guide the requirements of the cleaning programme.
As part of the cleaning process it is often necessary The more highly controlled areas will usually warrant
to use antimicrobial chemicals which are used to kill the most frequent and intensive cleaning methods.
or inactivate any micro-organisms remaining after Non-classified outer areas should also be included
cleaning. These are usually referred to as disinfectants in the cleaning programme and a high standard of
or sanitisers and are available in a wide range of housekeeping and cleaning in areas adjacent to the
formulations. controlled areas will assist in overall contamination
control.
ISO 14644-5 Operations ref 1 gives limited guidance
on cleanroom cleaning but the cleaning system Microbiological control
and materials will be largely developed to suit the When the cleanroom is producing biomedical products
requirements of each cleanroom facility. the main emphasis is on the control of micro-organisms
and the highest level of control is required during
Significant factors which will influence the cleaning aseptic manufacture.
programme;
• The product being manufactured This requirement will influence the cleaning methods
and materials. Micro-organisms form part of the
• The cleanliness classification(s) of the facility
microscopic contamination and so great care must be
• The requirement for microbiological control taken to ensure the removal of viable organisms during
• The size of the facility this stage of cleaning.

• Hours of operation
Anti-microbial chemicals will be required as part of the
• Production equipment and machinery cleaning process and all cleaning products and materials
• The number of staff will be sterilised before use. Following cleaning no
• The types of contaminant present residues should be left on cleanroom surfaces.

• Health and safety requirements

Plant size
• Availability of trained cleaning staff Cleanrooms vary in size from small units, perhaps
• Cost containing one isolator, to very large microchip
manufacturing plants. The same cleaning principles will
apply whatever the size of the manufacturing operation
The product
but the scale of cleaning will be very different.
The product being manufactured must be protected
from damaging contaminants. This may range from
The size and type of cleaning equipment needed,
large fibres e.g. for optical or surface finished products
purchase and storage of cleaning materials and staff
to microscopic particles harmful in microelectronics
requirements will all increase with larger and more
manufacturing. Biomedical products will be especially
complex cleanroom facilities. For a large operation the
damaged by viable particles.
cleaning programme will be a significant cost and is
likely to be managed by a dedicated team. In a small
cleanroom the cleaning programme may be managed
and carried out by the area production staff as part of
their normal duties.

84
Operational hours Cleaning of machinery may also produce significant
All staff involved in cleanroom operations have a additional contamination of adjacent areas and this
responsibility for a “clean-as-you-go” approach. must be considered when developing the overall
This ensures that staff are aware of the cleaning cleaning plan.
requirements and help to maintain the facility in good
condition throughout production. Staff numbers
Cleanroom staff will create particulate contamination
In addition it is preferable for the full, regular cleaning in their area of work; more particulate will be produced
cycle to be carried out when the cleanroom is not with increased activity. The numbers of staff and their
producing product. This gives better access for the activity level must therefore be taken into account when
cleaning staff and their equipment without disruption assessing cleaning requirements. Contamination from
to production activities. When wet cleaning is being discarded cleanroom disposables and clothing together
performed surfaces may become slippery and this with the associated packaging will also increase. It is
can pose a slip hazard especially on smooth flooring likely therefore that as the number of operational staff
surfaces. increases so too will the requirement for cleaning and
housekeeping.
During cleaning operations the actions of the cleaning
staff may generate temporary increases in airborne Types of contaminant present
particulate which could be damaging to product being Particulate from cleanroom staff will be viable and non-
manufactured at the same time. viable particulate from lost skin fragments together with
particles and fibres from clothing. These particulates
For these reasons it is preferable to time the cleaning will be mostly microscopic and removed by standard
programme around the operational hours. cleanroom cleaning techniques.

When the production operation is continuous and Some manufacturing operations however may
cleaning must be carried out during production it produce contamination which presents a chemical,
is especially important to ensure that any cleaning microbiological or radiation hazard. This may occur for
operations are safe and do not compromise the process. example when cytotoxic drugs are being prepared or
during virus production for vaccine manufacture.
Production equipment and machinery Cleaning protocols for these contaminants need to be
The presence of production machinery and equipment established and all staff made aware of the procedures
in the controlled area will present two issues. The for cleaning and disposal of contaminated materials.
equipment itself may disperse particulate or vapour Contamination may also occur which is difficult to
into the area and so contribute contamination during remove. This contamination may be present in particular
operations. Removal of the contaminants produced by work stations or departments where materials such
equipment may require specific cleaning methods and as adhesives, sealants and inks are used as part of the
cleaning agents. manufacturing process.

Machinery and equipment may also require cleaning These types of materials will not be removed by normal
both externally and internally on a regular basis and this cleanroom cleaning methods or products and will
needs to be included in the cleaning programme. require special procedures to ensure they are effectively
Any cleaning procedures for machinery must enable removed and that no residues remain.
the required cleaning to take place without risk to the
equipment or cleaning staff. When cleaning of this type Health and safety requirements
is performed a Health and Safety risk assessment is Cleaning operations will take place in enclosed
likely to be required and appropriate safety procedures cleanrooms, usually not during normal production hours
must be in place and strictly followed. and with minimum staff present.

85
The cleaning procedures may include the use and The full extent of the cleanroom cleaning requirements
dilutions of different chemicals some of which may be and associated hazards should be established when
harmful or flammable. developing a cleaning system and a health and safety
risk assessment carried out on all aspects of the
Cleaning staff may have to access difficult areas and cleaning programme to address these types of issues.
work on or near electrically powered machinery.
Application of solutions to smooth surfaces such as Staff availability
floors can generate a slip hazard. Hazardous materials All cleanroom staff have responsibilities for keeping
may be present in the controlled areas both as the area clean. As a minimum this involves the correct
contaminants and as process components. Cleaning disposal of packaging, consumable items and re-usable
staff may need to be equipped with items of personal clothing and removal of visible contamination.
protective equipment (PPE) which must be compatible A “clean-as-you-go” philosophy is usually adopted with
with the cleanroom environment. each member of staff responsible for the general care
and cleanliness of their work area and may include
An example is shown below and is a battery-powered regular wipe down of critical surfaces.
air fed hood to control the inhalation of sporicidal
disinfectant solutions used during healthcare cleanroom However most cleanroom cleaning is carried out
cleaning. separately from production activities and undertaken by
trained cleaning staff.

Staff performing these duties must be thoroughly

trained in cleaning operations and also in the general
rules for staff operating in the cleanroom.

Cleaning staff have a great influence on the continued

successful operation of the facility and may often work
unsupervised. Training should therefore include basic
cleanroom technology and the requirements for GMP.

Cleaning staff must be equipped with full cleanroom

clothing as well as any PPE and follow the changing
procedures for each area.

When large areas require cleaning, or for special

cleandowns e.g. following a new build, specialised
cleanroom-cleaning contractors can provide a good
alternative to in-house staff.

Cost
Once the cleaning requirement has been established
it is advisable to investigate various options to obtain
the best solution at the lowest cost. The total cost of a
cleanroom cleaning programme is made up of a range
of items including staff, cleaning materials, wastage and
disposal charges.

Battery powered air-fed cleanroom hood

86
It is often necessary to assess different cleaning When producing a cleaning plan the different
materials both for their cleaning efficiency and cleanliness zones and areas of greatest risk to product
ease of use in a specific location. For example in a should be detailed.
cleanroom with a large surface area and low cleanliness
classification it may be satisfactory to mop the floor Locations of manufacturing equipment, dedicated
using a mop and a two or three bucket system using cleaning equipment e.g. connection points for built-in
concentrated cleaning agents or disinfectants diluted by vacuum system and garment issue and disposal points
staff at point of use. For cleanrooms with smaller floor should be shown.
area and for those with high classifications, sterile mops,
pre-impregnated with a volume of RFU (ready for use) Any areas of notable hazards, first aid boxes and
chemical, may be more cost effective. emergency exits must be clearly identified.
The cleaning plan will include details of the cleaning
Cleaning equipment can be purchased or leased and equipment and chemicals and the associated dilution
some items such as mops and wipes may be re-usable and application rates specific to the production unit.
and require a cleaning and decontamination service. The order, frequency and methods of cleaning will
It is beneficial to discuss the full cleaning programme also be chosen to suit each unit however the following
with specialist suppliers of cleanroom products who will principles of cleanroom cleaning will apply to all plans.
be able to provide advice and information on suitable • Cleaning must start with the cleanest area and finish
products and the most cost effective solutions. with the least clean area.
• Cleaning follows the air pressure cascade in a series
7.3 of cleanrooms from the highest pressure to the lowest
Cleaning Plans, SOPs and Records pressure.
• In a cleanroom cleaning starts at the point furthest
Once all information relevant to the cleanroom cleaning
from the exit and works towards the exit.
requirements has been assessed a cleaning plan should
be created. The plan will provide clear information when • Cleaning is carried out in a series of steps starting with
discussing requirements with cleaning suppliers, and the removal of visible contamination followed by the
for developing cleaning standard operating procedures removal of microscopic particulate.
(SOPs) and a staff training programme. • When a chemical sanitiser is used the correct
concentration, volume and surface contact time must
Any changes to the cleanroom facility or its function be clearly stated.
must be assessed using the cleaning plan and a new • No cleaning equipment or products must be specified
revision of the plan produced when required with which will produce particulate contamination or leave
traceability of the changes implemented. A cleaning harmful residues.
plan will be a useful reference when cleaning
• Cleaning operations which have the potential to cause
validations and re-qualifications are performed and is
contamination e.g. emptying garment discard bins,
also essential for customer or compliance audits.
must be identified and confined to non-critical areas.

The cleaning plan will define; • Any staff involved with cleaning must be properly
trained and equipped.
• What is to be cleaned
• Any cleaning operations involving hazardous materials
• How the cleaning will be carried out
must be identified and all aspects of cleaning and
• When the cleaning is to be carried out disposal clearly described.
• Who is responsible for cleaning • All cleaning activities need to be appropriately recorded.
The cleaning records need to be reviewed on a
scheduled frequency and retained for future reference.

87
For a small operation a cleaning plan may provide Portable vacuum cleaners
sufficient cleaning information. It is usually beneficial These machines are simply plugged into an electrical
however to produce standard operating procedures supply and used by the operator in a specific location.
(SOPs) for each cleaning task. SOPs not only provide This gives easy access to areas and allows cleaning staff
detailed instructions for anyone performing a cleaning to use one machine in a variety of situations and with
task but also form the basis for staff training. different nozzle attachments. The cleaners are available
in a wide range of sizes, types and costs including
Cleaning logs are completed by staff to ensure that all wet and dry vacuum systems. To be compatible with
cleaning operations are being carried out correctly and cleanroom use portable vacuum cleaners must be easily
on-time. These documents act as a check list for the cleanable and no part of the machine or its attachments
cleaning staff and can also provide evidence that the should produce any contamination or damage to
cleaning procedures are being followed correctly. cleanroom surfaces. Equipment with electro-static
dissipation properties is available.

To control particulate dispersion from the vacuum

airflow HEPA or ULPA filters are fitted to the machine.
These can be attached to the motor, exhaust line or
both. Whatever configuration of portable vacuum
cleaner is chosen it must be compatible with the
cleanroom in which it is to be used. Great care must be
taken when opening and emptying these cleaners to
minimise contamination to the area, the user and the
machine itself. Periodic checking of the HEPA or ULPA
filters is required to confirm correct operation.

A series of diagrams of the cleanroom areas to be cleaned is a clear

way to develop a cleaning rationale

7.4
Vacuum Systems

Vacuum cleaning usually provides the first stage of

cleanroom cleaning and is used to remove visible
material from surfaces such as floors or machinery.
There are two main systems used in cleanrooms and
both are often used in the same facility for different
tasks and areas;
• Portable cleanroom vacuum cleaners Portable cleanroom vacuum cleaner
• Built-in vacuum cleaning systems

88
Built-in fixed vacuum cleaning systems
Central vacuum cleaning systems are extensively used
in large cleanrooms with all waste removed to a remote
central collection point. Vacuum tubing is connected to
wall mounted ports and so no exhaust air is returned to
the room.

Wet or dry systems can be installed. When designing a

built-in system care should be taken to site the vacuum
ports in positions which will enable staff to easily access
surfaces to be cleaned without needing excessive
lengths of vacuum pipe.

Microfibre mop cleaning surface

7.5
All components should be easily cleaned,
Mops decontaminated and sterilised if necessary. The mop
must also be able to withstand the abrasion from
Cleanroom mops clean effectively by wiping surfaces
surface contact, which can be especially severe with
and so can be employed to remove the invisible
some non-slip cleanroom flooring finishes.
contamination which cannot be removed by vacuum
Disposable cleanroom mops are available but due to
cleaning. Mops are particularly suitable for large flat
the high cost of disposable products re-usable mop
areas such as floors and walls and different designs of
systems are normally employed.
mop head, frame and handle are available for different
cleaning operations and locations. Mops can also be
There are two main systems available for re-usable
used to quickly apply anti-microbial chemicals to large
cleanroom mopping.
surfaces.
• Impregnation and rinse bucket-system
Mops should be used in long overlapping strokes so • Pre-impregnated system
that all the surface area is covered sequentially.
Bucket system
The cleaning action of mopping comes from the This is the traditional mopping system modified for
physical drag forces applied to the particulate and cleanroom use.
removal efficiency is greatly enhanced when a wet
mopping system is used. The greater the surface area A bucket is used to impregnate the mop with cleaning
of the mop in contact with the surface the better the agent and then to rinse the mop between applications.
wiping action and so any cleanroom mop should
provide intimate surface contact. Mops manufactured This single bucket system has the obvious disadvantage
from microfibre are especially efficient for this reason. that from the first rinse onwards the cleaning solution
becomes increasingly contaminated until it is merely
All materials used in the construction of the mop, the recontaminating the surface with each mopping. It is
mop frame and the handle should not be a source also possible that harmful contamination from a local
of fibre or particulate which could contaminate the area will be removed and then spread throughout a
cleanroom. much greater area.

89
 Single stage bucket mop system. Image courtesy of Basan UK Ltd. Three stage bucket mop system. Image courtesy of Basan UK Ltd.

To introduce a rinse stage a two or three bucket system Once the cleaning operation has been completed, or
can be used which will also usually include a ringer to the cleaning agent needs replacing, the buckets must
remove excess liquid from the mop. The whole system is be emptied and cleaned before being stored dry. It is
usually mounted on a large, wheeled trolley. preferable to wipe down the equipment after use to
ensure that no liquid remains which can quickly become
For a two bucket system, bucket one is filled with the a source of microbiological contamination.
cleaning solution and the other with rinse water. The
mop is impregnated with cleaning solution, wrung to Bucket systems are widely used for low grade areas and
remove excess liquid and applied to the floor. Once for cleanrooms with large floor areas and easy access.
the operator decides that the mop requires rinsing it is The equipment trolley is large and the buckets must be
placed in the rinse water bucket, wrung again and then filled and emptied so adequate provision must be made
re-impregnated in the cleaning solution and the cycle for chemical and equipment storage and waste liquid
repeated. There will be carryover from the rinse water disposal. It is advisable to carry out a Health and Safety
which gradually dilutes the cleaning agent and the rinse risk assessment, which includes manual handling, on
water becomes contaminated thus reducing its ability to cleaning operations using bucket mopping systems.
clean the mop between each use.
Pre-impregnated system
The three bucket system adds a discard bucket. This modern simplified mopping system was developed
Following impregnation and use as much as possible specifically for cleanroom cleaning and does not require
of the contaminated liquid is removed into the discard buckets or wringer. In this mopping system the mop
bucket by wringing. head is contained within a sealed pouch. The pouch
is opened just before use and a small volume (approx.
The mop can then be rinsed, wrung and re-impregnated 200mls) of pre-diluted cleaning chemical added.
with new cleaning chemical as in the two bucket system.
The three bucket system has the same dilution and
carryover problems as the two bucket system but they
are greatly reduced by the addition of the third bucket.

90
The mop is allowed to absorb the entire added chemical
before being removed and fitted to the frame and
handle. A specific square meterage of surface (usually
around 20m2) is then mopped. Once this area has
been covered the mop is removed from the frame
and discarded for cleaning, decontamination and re-
pouching. A new mop is then used in the same way for
subsequent areas.

Mops may be sourced which are packed singly or in

multiples allowing several to be impregnated at one
time. It is also possible to obtain mops which are already
impregnated with the chosen chemical and in this case
the mop only requires removal from the pouch and is
then ready for use. Sterile mops are available if needed.
As the mops are pre-impregnated with the correct
volume of chemical to cover a specific area all the
chemical is used for cleaning or disinfection and so no
wasted excess chemical remains to be discarded at the
end of the cleaning procedure.

This system removes the risks of cross contamination

and chemical dilution present with bucket systems and
the only equipment required is the mop frame, handle,
mop heads, discard bag and pre-measured doses of the
correct chemical. If the mop heads are supplied pre- Pre-impregnated mop system in use
impregnated with chemical then this further reduces the
equipment needed.
7.6
As there is no handling of large volumes of chemicals
Wipes and Swabs
the Health and Safety hazards associated with chemical
dilution and the lifting of large buckets are also Wipes are used in all cleanrooms as one of the main
greatly reduced. This cleanroom mopping technique cleaning methods.
is especially suited to high grade cleanrooms and for
those with restricted access. They are chiefly used to remove the invisible
contamination of particles and fibres 50µm and smaller.
Uses include the wiping of surfaces such as bench
tops, the cleaning of small pieces of equipment such
as bottles or trays, wipe down (or preparation) of items
or their outer packaging before being taken into the
cleanroom or isolator and glove wiping for cleanroom
staff. Wipes may also be needed to absorb and pick up
spillages which occur during the production process.

Wipes may be used dry but are much more efficient in

removing contamination when dampened with cleaning
or sanitising solutions.

91
In all instances wipes for cleanroom use must not Where the wipe will come into contact with hot surfaces
introduce significant particulate or fibre contamination it should have sufficient heat resistance to withstand
into the controlled areas. this without damage. If control of electro-static
dissipation (ESD) is a requirement the wipes must have
In a few operations, notably surface finishing, re-usable good ESD properties.
wipes may be employed which can be re-processed
by a cleanroom cleaning and decontamination plant, Cleanroom wipes should have good sorption. This
however the majority of cleanroom wipes are discarded indicates the volume of liquid the wipe will absorb in
after a single use. relation to its weight and the time taken to do this.
Good sorption properties will allow a wipe to quickly
Wipes are available in a very wide range of materials, take up a spillage and will also enable an impregnated
presentations and price and so it is important to select wipe to cover a large area without drying out.
the product which will satisfy cleaning requirements in
the most efficient and cost effective manner. Wiper materials
Cleanroom wipes are usually manufactured from knitted
The main factors to consider when comparing or non-woven fabrics however woven fabrics and foam
cleanroom wipes are; material wipes are also available.
• Physical properties Wipes specified for use in high grade cleanroom areas
• Wiper materials are usually produced from knitted filament yarns,
• Wiper edge finish usually polyester or nylon, and these include those
made from microfibre yarns which give increased
• Wiper size, fold and packaging
surface contact area.
• Wiper cleanliness and sterility
Filament polyester is low shedding and can be
• Dry or pre-wetted wipes
effectively cleaned and decontaminated before use.
• Supporting documentation It will withstand sterilisation by gamma irradiation or
• Cost autoclaving without damage.

Knitted fabrics are very pliable and this allows the wipe
Physical properties
to maintain a high contact area and to be easily folded
Wipes are made from materials which must have good
for use.
surface contact so that particles can be pushed free
from the surface being wiped. Knitted fabrics generally have high sorption properties
which increase with fabric weight and this will further
Wipes must not be abrasive or cause damage to increase when the wipe is produced as a double layer
the wiped surface. Wiper materials must be able to (2-ply).
withstand the cleaning operation without tearing or
suffering surface breakdown resulting in the loss of Non-woven materials are usually a combination of
particles and fibres from the wipe. polyester and cellulose or polypropylene and are
normally specified for use in lower grade cleanrooms,
The wiper materials must be compatible with any less critical wiping operations or spill control. The
chemicals with which they come into contact and not materials can be sterilised for aseptic area use and have
be dissolved or otherwise broken down by cleaning good sorption.
agents or production chemicals. In many applications
the wipe should not contain materials which can be
released in solution during use such as ionic chemicals
or endotoxins.

92
As wipes are usually a disposable product it is Wiper cleanliness and sterility
preferable to use materials which can be re-cycled. Knitted, woven and non-woven fabrics for wiper
manufacture are produced in large industrial plants
Wipe edge finish and the fabrics will become heavily contaminated with
Wiper fabric is produced in large rolls and must be cut fibres, particulate, micro-organisms and chemicals from
down to produce individual wipes. The cut edges of the the production process. This contamination is increased
wipe can produce particles or fibres and to reduce this when cutting the wipes to size and if they are to be used
source of contamination the wiper edges can be sealed in an environment where this would present a problem,
using various methods including sealing with heat or the wipes must be cleaned and decontaminated before
laser and heat rolled edges. use.

Wipe size, fold and packaging This is normally achieved using a cleanroom cleaning
Wipes are available in an extensive range of sizes and and decontamination plant and the process is
presentations. highly successful in decontaminating woven or
knitted polyester wipes. It is not possible however to
They may be presented flat in a layer with each wipe decontaminate cellulose wipes in this way.
being removed by the user. Wipes may also be folded
so that they are interleaved and removing a wipe pulls Suppliers of cleanroom wipes will be able to provide full
the start of the next wipe from the pack. data on particulate and fibre levels of different wipes
and information on chemical contaminants such as ionic
Wipes can be sourced on rolls, in tubs, or in individual materials and endotoxins.
packs and most packaging will incorporate a re-sealing
system, especially if the wipes are pre-wetted with a A wide range of sterile wipes is available and are usually
volatile chemical such as an alcohol or solvent. required in aseptic manufacturing processes. Wipes are
Several layers of packaging may also be utilised to routinely sterilised by gamma irradiation to achieve a
facilitate transfer into a high grade area. sterility assurance level (SAL) of 10-6.

Dry or pre-wetted
Whatever packaging is employed clear and adequate Cleanroom wipes are available either dry, or pre-wetted
labelling must be used which is not damaged by wiping with a cleaning or sanitising solution. All types of wipe
with alcohol or other solvents and the packaging materials can be supplied in these formats.
material must not produce significant fibre or particulate If wipers are to be primarily used to absorb spillages
contamination during opening. then dry wipes are used. In cleaning applications
however, wiping is carried out using a liquid to dampen
Whenever possible packaging and containers for wipes the wipe to improve particulate removal.
should be made from materials which can be re-cycled.
If an anti-microbial solution is used a layer of sanitising
solution will also need to be deposited by the wipe
to kill or inactivate micro-organisms which have not
previously been removed.

A solution can be applied to a dry wipe just before use

using a dispenser or spray however the chemical must
be prepared in advance and will not be evenly absorbed
by the whole wipe giving uneven application.

Folded, impregnated wipes

93
Pre-wetted wipes provide the simplest option and are Supporting documentation
dosed with a specified volume of chemical before the When inexpensive, non-sterile wipes are utilised
pack is sealed. This allows the impregnated chemical for wiping operations a basic product specification
to be evenly absorbed and gives an optimum chemical is sufficient which identifies the wiper material,
loading on each wipe. contamination levels and general product information
on quantity and presentation. If pre-wetted wipes are
Pre-wetted wipes can be sterilised following chemical being used then a materials safety data sheet (MSDS)
dosing so ensuring both wipe and chemical are sterile at will also be supplied.
the point of use.
For more highly specified wipes used in high grade
When volatile chemicals are used to pre-wet wipes the areas additional documentation will be required to
packaging must be effective in stopping any chemical confirm the acceptability of the wipe before use. This
evaporation from the pack during storage and should will include full batch traceability for each individual
also incorporate a re-sealable opening to stop loss of wipe pouch, details of particulate and chemical
chemicals once the pack is opened. Sterilised wipes, contamination levels, confirmation of pouch materials,
pre-wetted with alcohol are used within high grade certificate of irradiation when sterility is required and
pharmaceutical cleanroom areas. For such applications, colour-change detex irradiation labels on each pouch. A
pre-wetted wipes have significant advantages over MSDS will be required for all impregnated wipes.
the use of similar dry wipes and alcohol discharged Full documentation is usually supplied with each
as an aerosol from a canister. Such canisters deliver box of wipes and this may need to be included in
vast quantities of alcohol particles into the cleanroom cleanroom product batch records to satisfy regulatory
which remain airborne for extended periods of time. requirements.
These particles are likely to be ‘counted’ by any
particle counters present in the cleanroom and will When wipes are required for critical areas the user
consequently record artificially high levels of airborne will wish to audit the wipes production facilities and
particles ref 2. Additionally, such particles will be readily the supplier will maintain records providing full batch
inhaled by personnel present within the cleanroom with traceability for the whole supply chain.
significant associated health concerns.
Cost
Cleanroom wipes are available within a very wide price
range. The material used for the wiper, edge finish, wipe
size and presentation, packaging, level of cleanliness
and supporting documentation all affect the final cost.
Sterilisation and pre-wetting also significantly increase
costs.

This means that the more highly specified and

controlled the wipe the higher the cost and so it is
important to ensure that the correct wipe is clearly
identified for each area and each wiping operation.

Airborne particles generated by an aerosol delivery system

94
Use of wipes When using wipes to decontaminate critical areas it is
Each cleanroom cleaning plan will clearly identify the good practice to fold the wipe to provide eight separate
specific use of wipes however there are some useful cleaning faces. The wipe should be used in single
guidelines to adopt when using wipes in any cleanroom. overlapping strokes with a maximum of eight passes
• The cleaning plan and standard operating procedures (one for each folded face) per wipe (as shown in the
(SOPs) will indicate which wipes should be used for sequence of illustrations 1-5 below).
each cleaning application and only the specified wipe
should be used. This should also be made clear to
contractors or engineers who may be operating in the
controlled areas.
• When used for absorbing spills a dry wipe is simply
removed from the container and applied to the
spilled liquid. Once absorbed into the wipe the wipe
is discarded in a safe manner according to the area
procedures. A further dry wipe should then be used to
1
wipe over the area and remove any residual moisture.
• If cleaning or sanitising chemicals are to be applied to
dry wipes the chemical should be dispensed onto
the wipe and not onto the surface to be cleaned.
This minimises the possibility of chemical aerosols
contaminating the cleanroom.
• If pre-wetted wipes are used then care should be taken
to ensure that once opened the wipes container is
re-sealed between uses to stop loss of impregnant
through evaporation. When pre-impregnated wipes
2
containers have been opened and re-sealed several
times it is possible that evaporation has occurred and
the wipes are no longer wetted to the required level. In
this case the wipes should be discarded.

Effective packaging – validated for multiple opening and re-sealing

95
 7.7
Chemicals for Cleaning and Disinfection

Wet vacuum cleaning, mopping and wiping are all used

extensively in cleanroom cleaning. In some instances
water alone is used with these methods however in
most instances a chemical solution is employed to
enhance cleaning efficiency or provide anti-microbial
action. Whenever liquids are used for cleanroom
cleaning or disinfection they should be free from
contamination which could compromise the area. This
5 means that any water used must be purified to the
standard needed in the area to be cleaned. Water used
This technique will maximize particle removal and the for cleaning may therefore range from deionized water
surface area covered will depend on the size of the wipe to water for injection (WFI) quality. Chemicals should
and the quantity of liquid absorbed. not contain any suspended particulate and should not
• When wipes are being used to apply a sanitising leave particulate residues on cleaned surfaces after
solution care should be taken to ensure that sufficient evaporation.
chemical is transferred to the surface from the wipe
and that it is evenly distributed. Adequate disinfection Cleaning solutions must be effective in removing and
will not take place without the correct application of suspending contaminants but should not damage
sanitiser. surfaces being cleaned. Any Health and Safety issues
relating to fire hazard or toxicity should be clearly
• Wipes must be discarded correctly as indicated by the
understood and minimised.
cleaning plan. Any wipes containing chemical residues
either from spillages or chemical impregnants must be
For high grade pharmaceutical cleanrooms, used for
collected for safe disposal as indicated by the MSDS,
the manufacture of sterile products, it is a regulatory
Environmental and Health & Safety considerations.
authority requirement that the disinfectant solution to
be utilised is sterile prior to use. Typically this can be
Swabs
achieved by preparation of the disinfection agent in
In some instances small or inaccessible areas may
controlled areas which is then piped into the cleanroom
require cleaning using cleanroom swabs. These are
areas through sterilising grade filters and collected
available in a range of knitted and non-woven fabrics
in sterilised containers prior to use. Alternatively, the
and foams. Different designs of the swabbing tip allow a
disinfectant can be prepared aseptically, utilising
product to be selected which will satisfy most cleaning
sterilised equipment and irradiated disinfectant
applications. Full specifications on the cleanliness
concentrates in high grade cleanroom conditions. The
and cleanroom compatibility of each product will be
prepared solution may then be piped directly into the
available from the supplier.
cleanroom areas without the need for a sterilising grade
filter.

Cleaning chemicals
A surfactant is a chemical which lowers surface tension
and improves removal of solids from cleanroom
surfaces. Detergent products contain a surfactant or
a mixture of surfactants but may also include other
additives such as dyes or perfume.

96
Surfactants are classified as amphoteric, anionic, Disinfectants must be used at the correct concentration
cationic and non-ionic depending on their chemical and for a sufficient time to work effectively and it is
structure and detergents containing non-ionic important that the chemical comes into direct contact
surfactants are usually chosen for cleanroom use as with the micro-organisms.
they are free from electrically charged molecules.
Many different proprietary detergent compounds are There are several different types of chemicals which
available and full product specifications including the are used as disinfectants including alcohols, quaternary
MSDS will be available from the supplier. ammonium compounds (QUATS), chlorine, biguanides
and phenols. All have different modes of action and
In all instances it is recommended that a comprehensive varying effectiveness against different groups of micro-
trial is carried out on any cleaning product before it is organisms and no one, ideal cleanroom disinfectant
adopted for use. This should assess not only cleaning exists.
efficiency but also compatibility with the surfaces to be
cleaned, other cleaning materials and products. Many proprietary cleanroom disinfectants are a
mixture of different compounds and are formulated to
Cleaning chemicals can be sourced in concentrated or provide complementary modes of action and increased
ready for use (RFU) solutions and in different volumes. effectiveness.
When large areas are being cleaned concentrated
product will be most economical however dilution Full information on the anti-microbial activity of
of the product before use will require purified water disinfecting products will be available from the supplier
and must be carefully controlled to ensure the correct and standard tests are employed to give an indication of
concentration is used and that no contamination is the effectiveness of the product.
introduced. A risk assessment should also be carried out
to ensure the correct PPE and equipment is supplied to These include;
staff and that a safe handling procedure is adopted. • BS EN 1276 ref 3 Chemical disinfectants and antiseptics.
RFU products are useful when smaller areas are being Quantitative suspension test for the evaluation of
cleaned or if sterile products are required with the bactericidal activity of chemical disinfectants and
sterilisation process taking place after the product has antiseptics used in food, industrial, domestic, and
been dispensed into the final container. institutional areas. Test method and requirements
• CEN EN 13697 ref 4 Chemical disinfectants and
Many chemicals are supplied at RFU concentrations in
antiseptics. Non-porous surface test for the evaluation
easily portable dispensing containers such as trigger
of bactericidal and/or fungicidal activity of chemical
sprays, making them very easy and economical to use at
disinfectants used in food, industrial, domestic and
multiple locations.
institutional areas

Disinfecting chemicals • BS EN 1650 ref 5 Chemical disinfectants and antiseptics.

Products which have an anti-microbial action are usually Quantitative suspension test for evaluation of
known as disinfectants or sanitisers. Biostatic agents fungicidal activity of chemical disinfectants and
act to inhibit microbial growth whilst biocidal agents kill antiseptics used in food, industrial, domestic and
vegetative micro-organisms. Some bacteria and fungi institutional areas.
produce spores which are very resistant to adverse • BS EN 13704 ref 6 Sporicidal test. Quantitative
conditions and sporicidal disinfecting agents are suspension test for the evaluation of sporicidal activity
required to be effective against spores. of chemical disinfectants used in food, industrial,
domestic and institutional areas.
Disinfection is usually carried out as a last stage of
the cleaning process and is also the principle aim
when sanitising hands or ‘prepping’ materials being
transferred into cleanrooms or isolators.

97
Alcohols are routinely used as disinfecting agents in Contamination control mats (often called “tacky
cleanrooms and both filtered isopropyl alcohol (IPA) and mats”) consist of layers of plastic sheet coated with an
denatured ethanol (IMS) is used as a 70% solution in adhesive. The adhesive pulls particulate and fibre from
purified water. These sanitisers have the benefit of rapid footwear and wheels contacting the mat.
evaporation leaving almost no residue and are effective
against a range of vegetative organisms; however they Tacky mats are held in place by an adhesive backing or
have no sporicidal activity. by a floor mounted frame.

Because of these properties alcohols are widely used When the top sheet is contaminated it is removed
for hand and glove sanitisation and for the wiping down by pulling the edges into the centre so trapping the
of critical surfaces. contamination and exposing a clean sheet, the removed
sheet is then discarded. The individual sheets are often
There is a theoretical risk of micro-organisms becoming numbered to give an indication of use and frequency of
resistant to a particular anti-microbial compound if it changing is set by the cleanroom cleaning plan.
is used for an extended period. For this reason many
cleanroom operations have a policy of rotating two
disinfectants with different anti-microbial actions, on a
regular basis.

7.8
Contamination Control Flooring and Mats

Contamination control flooring and mats are used to

remove contamination from footwear and wheels at
the entrance to critical areas. In this way they aid the
cleaning process but themselves must be cleaned as
part of the cleaning schedule.

Contamination control flooring is manufactured from

polyester compounds with a high coefficient of friction.
This acts to physically remove and trap particles and
fibres carried on materials with which it comes into
contact, normally the soles of footwear and the wheels
of trolleys. The material does not therefore transfer
adhesive substances to the contacted surfaces.
It can be used as mats or as covering for the whole floor
and can also incorporate anti-static or anti-microbial Disposable tacky mat used to control foot borne contamination
compounds.

The flooring is cleaned using a cleanroom detergent and

mopping system and the frequency of cleaning will be
determined by the cleaning plan.

98
7.9
Confirming Effective Cleaning

The production and implementation of a ATP reacts with the enzyme luciferase to produce light
comprehensive cleaning plan and SOPs, together with and a surface sample can be taken from the area to be
well trained staff and accurate cleaning logs, will all give tested and combined with the reagent. The light emitted
confidence in the cleanroom cleaning programme. can be measured and provide immediate feedback
on cleaning efficiency. Although considered a helpful
Visual inspection of the area provides an indication of technique giving an immediate assessment of cleaning
the effectiveness of general cleaning and housekeeping efficiency this test method is not generally considered
standards, however, additional monitoring techniques accurate enough for high grade cleanroom areas.
can also be employed to determine the effectiveness of
the removal of invisible particles and fibres.
• Strong visible light can be shone onto a cleaned surface
at an angle of 45 degrees. This will illuminate
particulate to make it visible for inspection.
• Ultra violet (UV) light can be used to show particulate
which will fluoresce and this can be especially useful
when looking for fibres.
• Particulate and fibre-free glass or stainless steel plates
can be positioned on critical surfaces for a period
and then removed for microscopic evaluation of the
numbers of particles which have been deposited
onto the surface and these can be cleaned using the
standard techniques to evaluate removal efficiency.
• Cleaned surfaces can be sampled using automatic
particle counting devices however these rely on vacuum
removal of the particulate.

When the emphasis is on disinfection then

microbiological methods are employed and these
tests are routinely carried out in GMP classified bio-
medical cleanrooms to confirm levels of microbiological
cleanliness. Active air sampling, settle plates, contact
plates, surface swabs and finger dab sampling will
all indicate the degree of control achieved by the
cleanroom and the cleaning programme.

Systems which use bioluminescence to detect

adenosine triphosphate (ATP), a molecule which
supplies energy and is found in all cells, can be used to
give an immediate indication of cellular residues left on
a surface.

99
 SECTION

8.0
Planning, Sourcing and Optimising Cleanroom Clothing Supply

This section describes the key stages and requirements

for setting up a cleanroom clothing system for re-usable
items. Many of the elements discussed will also impact
on the sourcing of cleanroom consumables however for
clarity this is dealt with as a separate topic in Section
10.0 Planning, Sourcing and Optimising Cleanroom
Consumables Supply.

8.1
Planning the Process

Cleanroom clothing is a key element of the control

systems used to protect sensitive products from
contamination during manufacture.

Without the correct cleanroom clothing, manufacturing

units cannot operate effectively and a failure of clothing
supply will lead to a complete shut down of operations.
Cleanroom clothing is mainly re-usable and so the
clothing will need to be collected from the wearer
after use, processed by a decontamination plant and
then returned to the wearer in time for re-use without
deterioration of its contamination control properties.

This process must work unfailingly over the lifetime

of the clothing, which will be several years, and
replacement garments must be readily available in the
event of garment failure

Cleanroom clothing must meet all the requirements

of the Production and Quality Assurance departments;
it must be acceptable to the wearer and at a cost and
supply specification which will be acceptable to the
Purchasing department.

The selection and sourcing of the correct cleanroom

clothing programme is therefore a complex operation
which benefits from a planned and well-documented
approach.
Cleanroom clothing for different environments

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 8.3
The process will differ from site to site, however the New Cleanroom Clothing system or Review of
following elements should always be considered when Existing Supply Arrangements
arranging cleanroom clothing supply;
When a new cleanroom production unit is being
• Selecting a clothing sourcing team. developed the provision of cleanroom clothing should
• New cleanroom clothing system or review of existing be considered at an early stage.
supply arrangements?
• The budget and timescale. The manufacturing operation, cleanroom classification,
and contamination control emphasis will all be major
• Fabric and garment style selection process.
considerations. The numbers of staff moving in and out
• Determining the numbers of garments required. of the cleanroom facility, changing procedures and staff
• Cleanroom clothing distribution systems. access to cleanroom clothing are also important factors.
Early specification of the cleanroom clothing system
• Supply options and supplier selection.
will provide adequate time to decide on the hardware
• Implementation and maintenance of the required for distribution and collection, such as
clothing system lockers, bins or racks, and the most appropriate fabrics,
garments and decontamination services.

8.2
As there will be no existing supply arrangement the new
Selecting a Cleanroom Clothing Project Team service must be fully functioning from the production
start date with all elements of the system in place.
To implement an effective and cost efficient cleanroom
clothing programme requires input from various sources
When a production facility has an existing cleanroom
and it is often beneficial to establish a small team with
clothing system it is sometimes necessary to review the
a designated team leader to undertake the task. This
supply arrangements. This may be needed for a variety
is especially beneficial for larger operations where it
of reasons such as;
will be necessary to collect and manage a considerable
amount of information and to communicate effectively 1. Purchasing department contract review procedures.
both internally and with external suppliers. 2. Change in Production Unit manufacturing activity.
3. New Regulatory or QA requirements.
For a new cleanroom clothing system or a complete
4. Dissatisfaction with the current arrangements.
clothing review the process is likely to take several
months to complete and will involve significant costs.
The existing system will have both a service and
Key input will be from Purchasing, Production and
financial history and this will provide the starting point
Quality Assurance departments.
for the review.
Additional help may also be required from company
Supply contracts are likely to be in place and the
Auditors, Health and Safety representatives, cleanroom
contractual obligations will need to be clearly
staff who will use the clothing and garment distribution
understood together with the full implications of
staff.
change.
It is also beneficial to start discussing requirements and
The regular review of an existing cleanroom clothing
options early in the process with prospective suppliers
system is an excellent tool to identify areas for
to obtain their input and advice.
improved contamination control, service improvements
and to provide increased cost control.

101
8.4
The Budget Proposals from prospective suppliers can then be
obtained and reviewed and supplier audits arranged.
When an existing cleanroom clothing service is in Final discussions can then take place and once supply
operation the current budget will already be known. contracts have been agreed and contracts signed,
If a new cleanroom clothing system is required then the measurement of all wearers must take place before
costs of various options will need to be established and garments can be ordered for manufacture.
a budget allocated according to the choices made.
There are two principle options for supply, either direct Fabric supply, garment manufacture, delivery, labelling
purchase of equipment, clothing and decontamination and processing by the decontamination plant prior to
services or a managed rental programme. delivery and installation on site will then be required
before the clothing can be delivered to site for use.
For direct purchase a large initial capital outlay is
required to fund the full cost of all garments, labels and If new fabrics or garment styles are required then
distribution equipment. sampling, wearer trials and validation exercises will all
add significantly to the overall timescale.
Once the cleanroom clothing and equipment is in place
then a variable maintenance budget will be required
to cover garment replacements and additions as well 8.6
as all costs associated with garment maintenance and
Fabric and Garment Style Selection Process
decontamination.
Fabrics
When a managed rental programme is chosen Suitable fabrics are available to meet all contamination
the budget is fixed for an agreed period without control requirements both as outer wear and as
initial capital cost and incorporates all aspects of undergarments.
the clothing programme including the cleanroom
clothing, decontamination services, garment repair and Readily available fabrics will have been extensively
replacement, delivery, distribution and management evaluated by standard laboratory tests and used in a
reports. variety of manufacturing situations. This test data and
lifecycle history provides excellent assurance that the
fabric will perform well throughout the garment life.
8.5 These fabrics will also be available in an established
Timescales range of colours.

Timescales are likely to be longer for a new start-up When special properties such as water repellency or
situation and also in facilities when large numbers of chemical resistance are required then there will be
staff and departments are involved. Any major changes a more limited fabric range. Technical test data will
to an existing cleanroom clothing system will also be available to demonstrate the effectiveness of the
require adequate time to implement. fabric, however in most instances it is beneficial to trial
these fabrics in the areas of use before making the final
If an existing supplier is to be replaced then cancellation decision.
of the original contract must be timed to coincide with
the start of the new supply arrangement.

The initial stage is to collect basic information on the

requirements of the cleanroom clothing service and
to discuss these requirements with possible suppliers,
obtain samples and agree garment types.

102
 Cleanroom fabric - filament polyester with ESD stripe

Cleanroom fabric - filament polyester with ESD grid

New fabrics can be developed for a specific end use, Typical cleanroom undergarments
however this is very time consuming and expensive and
is not recommended except in extreme cases where no Whenever possible it is much more cost effective and
suitable fabric exists. efficient to select a suitable existing garment style than
to design a new garment for use by a specific site.
Garment styles New design requires initial input from managers,
Many cleanroom garment styles are available and all are wearers, clothing designers and a pattern maker,
variations on the same basic patterns, these are; followed by production of sample garments for trial.

• Coat
Once successful trials are completed (which may
• Coverall necessitate several stages of modifications, re-sample
• Overboots and re-trial) the pattern can be graded to provide
the full size range and full garment sets are normally
• Hood
produced to be finally tested and approved. Only then
• Top and trouser undergarment set can garment manufacture commence.
• Top and trouser outerwear set
As the new style will be unique to the specific site
Samples of standard garments will be readily available additional garments, covering the complete size
for evaluation and trial by the garment selection team range, must also be ordered to be held as stock for
and the wearers. replacements or additions.

103
8.7
Determining the Numbers of Garments Required Choice of garments, special properties or
decontamination requirements
The type and numbers of cleanroom garments required The fabrics, garment styles and changing procedures
to adequately supply production is one of the most must first be agreed by all departments.
critical pieces of information needed when developing
an efficient cleanroom clothing service. Any requirement for garments with special
properties such as water repellency, fire retardancy
If the specified number of garments is too low then
or ESD properties should also have been identified
the flow of garments between the manufacturing unit
together with the areas in which they are to be used.
and decontamination plant will fail resulting in garment
Some specialised cleanroom fabrics may require
shortages and production downtime.
unusual processing and more complex testing at
the decontamination plant and this may mean more
If the specified number of garments is too high then this
garments are required to allow more process time.
will significantly increase costs without any additional
benefit.
Change frequency
For a small operation with only a few wearers it is The frequency of garment change is one of the major
relatively easy to establish the clothing requirements, factors determining garment numbers.
however for large manufacturing sites with different In some instances it may be appropriate to only change
departments and different standards of cleanrooms it outer garments once per week with the clothing stored
can be difficult to obtain an accurate picture of clothing between use in clean areas or clean air cabinets.
requirements. In many operations however, especially biomedical and
pharmaceutical production areas, it is usual to change
The following check-list identifies the key areas
outer clothing on each entry to the cleanroom. Daily
for investigation to arrive at an accurate picture of
change and twice weekly change are also commonly
cleanroom clothing use and will provide a helpful guide
used.
for any cleanroom clothing project team.
As an example:
It is recommended that this check-list is used to collect
In a production area with 10 staff working 5 days per
information for each separate manufacturing unit or
week, changing once per week, 10 garments will be
department.
used each week. (10 staff x 1 change)
• Choice of garments.
• Clothing with special properties or decontamination In a production area with 10 staff working 5 days per
requirements. week, accessing the cleanroom 4 times per day and
• Change frequency for each garment style. changing on entry 200 garments will be used each
week. (10 staff x 20 changes)
• Number of production staff accessing the cleanroom
per shift.
Number of production staff and shift pattern
• The shift pattern in operation throughout the year. The number of staff working in the cleanroom areas
• Clothing required by Engineering staff, QA staff and is the second major factor when establishing garment
occasional visitors. numbers.

• Garment distribution and gowning system in operation.

When a single shift with unchanging staff numbers
• Wearer identified garments or pool stock clothing system. is operated throughout the year, estimating weekly
• Sterilisation requirements both before and after use. garment usage is straightforward - as seen in the
• Clothing identification for specific areas or staff. examples above.

• Dangerous or difficult garment contaminants.

• Repair options for damaged clothing.

104
With complex shift patterns and variations in production
output more complicated clothing usage patterns are
created. When this is the case it is necessary to obtain
an accurate forecast of the maximum quantities of
cleanroom clothing required to maintain production
throughout the year.

This will enable the cleanroom clothing team to specify

a sufficient number of garments to cover the highest
level of predicted use and avoid shortages.

Engineering staff, QA staff and occasional visitors

When cleanroom equipment is used which needs
routine attention, engineering staff may need to
regularly enter cleanroom areas. This can lead to a
Cleanroom garments being placed into distribution racks for use
significant increase in the weekly garment requirement.
Other non-production personnel such as QA staff,
trainers and visitors may also require cleanroom When a strict aseptic gowning technique is required
clothing for occasional use and this should be it is possible for cleanroom staff to inadvertently
accounted for when deciding total garment numbers. contaminate sterile garments during the changing
procedure. This will mean that the garment set is
Garment distribution and gowning system discarded and that additional replacement garments
The garment distribution and gowning systems may need to be available.
have an impact on the number of clothing items used.
Poor storage and handling can cause damage to Technically difficult changing procedures also need
packaging, resulting in unused clothing being removed extensive training and practice to perfect and an
for re-processing, reducing the number of garments additional supply of cleanroom clothing is required for
available for use. this purpose.

If the distribution system is erratic then staff may Wearer identified or pool stock cleanroom clothing
choose to keep their own ‘personal’ garment stock system
which can again reduce the number of garments in Wearer identified
circulation. Incomplete collection and return of used If contamination control garments are required which
garments for cleaning and decontamination may also are only to be used by one specific wearer then each
lead to shortages of wearable garments. wearer will need to have a complete set of garments
supplied and identified to that individual. This is usually
referred to as a wearer identified garment system.
This option is often selected for undergarments, when
the name of an individual needs to be clearly visible,
if clothing is worn for several days, or if specific tasks
mean that some clothing will regularly suffer significant
wear or staining.

Garments can be labelled with a wearer number or

with a wearer name and the garments will need to be
available for collection by each wearer and this is often
achieved by distribution using individual distribution
lockers.

105
Pool stock Sterilisation by gamma irradiation is the current best
Cleanroom clothing may also be supplied as a option for packed, cleaned and decontaminated
circulating stock of garments with a range of sizes clothing items. It is effective and easily controlled,
available for use by any suitable wearer. This system is however cleanroom clothing fabrics will be degraded
usually referred to as a pool stock. over time by repeated irradiation processes.

These garments are presented for selection according to

size, usually from racking or bins.

Pool stock is often chosen to reduce the number

of garments required for a large workforce and
when simple styles of garments can be easily worn
throughout an area without significant wear or staining.
Name badges cannot be applied to garments using
this system. Staff acceptance and understanding of
a pool stock system needs to be established before
implementation. Staff may feel that using a pool of Control of sterilisation by gamma irradiation
garments may put them at risk of cross-contamination
from previous wearers, however a fully validated and When used clothing is sterilised before return to the
monitored cleanroom cleaning and decontamination decontamination plant this is usually achieved by
process will ensure that the clothing is thoroughly autoclaving the garments and this too increases fabric
disinfected and cleaned between each use with records damage and so decreases garment life. (See section 6.4
available to illustrate this. When sterile garments are for additional information).
utilised then this will give staff additional confidence in
the safety of a pooled garment system. Decreased garment life and the extra time required to
sterilise garments may mean that additional clothing is
needed to maintain a steady supply to production.

Clothing identification for area or staff

Some plants or departments may need to have
garments labelled in a way which visibly identifies the
department, the wearer, or wearer status e.g. First Aider.
This requirement needs to be clearly understood by
the project team and all the information for badging
or labelling of clothing must be collected and checked
before the clothing is ordered.
Cleanroom clothing being processed in a decontamination plant

Sterilisation requirements both before and after

cleaning and decontamination
The requirement for garment sterilisation following
decontamination needs to be decided and in some
environments, such as virus production, it may also be
necessary to sterilise cleanroom clothing after use and
before return to the decontamination plant.

Garment labelling using sublimatic printing

106
 8.8
Dangerous or difficult garment contaminants Cleanroom Clothing Distribution Systems
In some production processes the cleanroom clothing
may become contaminated with materials which A well planned and equipped cleanroom clothing
could be harmful to anyone handling the item, or with collection and distribution system, managed by properly
materials which are especially difficult to remove e.g. trained staff, will prove a great asset in the efficient
paint or inks. operation of the cleanroom.

It is necessary to identify these types of contaminants The clothing supply-system should enable cleanroom
whilst establishing a cleanroom clothing system. Many staff to obtain and change into decontaminated
options are available to deal with these issues including cleanroom clothing with minimal delay and
different fabric types and colours, specialised cleaning contamination risk.
methods and controlled packing and transport systems
and advice on the best way to deal with these issues After wearing, contaminated clothing needs to be easily
should be obtained from prospective suppliers. disposed of by the user and quickly dispatched to the
processing plant for cleaning, decontamination and
Repair options for damaged clothing subsequent return for use.
Damaged cleanroom clothing can be repaired in a
Each cleanroom facility will have its own physical layout,
variety of ways.
cleanroom clothing system and changing procedures
however the following points should be considered
Fixtures and fittings such as zips and studs can be
when establishing a system.
replaced, holes can be repaired using sewn or heat
sealed patches. • Staff responsible for the cleanroom clothing collection
and distribution system.
The level and type of repair which is acceptable to • Site access, delivery point and storage for bulk clothing
the plant or department must be determined by the supplies returned from the decontamination plant.
cleanroom clothing team and clear guidelines agreed • Distribution method at the point of use.
with the decontamination plant carrying out any repairs
• Storage between use (for clothing items worn
as part of the garment maintenance programme.
several times).
• Collection of soiled items and transfer to bulk
collection point.
• Arrangements for any items contaminated with
hazardous substances.

Staff responsible for the cleanroom clothing collection

and distribution system
For a small number of wearers it is useful to have a
member of staff with the responsibility to oversee
cleanroom clothing distribution. For larger operations
with multiple wearers and departments this is a vital
role.

This task can often be successfully carried out by an

existing cleanroom support team, by a dedicated
employee or by staff supplied and managed by the
cleanroom clothing decontamination plant.

Cleanroom garment repair

107
Site access, delivery point and storage for Distribution method at the point of use
bulk clothing deliveries returned from the Cleanroom clothing needs to be readily available for
decontamination plant the wearer in the changing areas. If a wearer identified
Collection and delivery of cleanroom clothing by the garment system is used then each member of staff will
decontamination plant will usually be by van. A time need to have their own distribution point and this is
and location for collection of the soiled clothing and usually achieved using named or numbered lockers.
delivery of the decontaminated clothing should be
agreed. Each wearer is assigned a locker and has sole access.
Decontaminated clothing is placed in the locker by
For a large facility this may include several points garment distribution staff so that it is available for the
around the site and may entail site-specific training for wearer when required. Several sets of clothing can be
the delivery driver. placed in the locker at one time.

When large quantities of garments are involved it may

be necessary to hold them in a dedicated area before
final distribution to production area changing rooms.

Garment storage lockers

Bulk delivery of cleanroom clothing When cleanroom clothing is supplied as a pool stock
then individual lockers are not required and the
distribution staff can place clothing in bins or on racks
When this is the case then the bulk holding area needs
according to garment type and size. The number of
to be designed to separate contaminated and clean
garments available needs to be periodically topped up
items to reduce the risk of cross-contamination. Several
to an adequate level and a procedure needs to be in
garment packaging layers may be required to help
place which ensures that stock is rotated regularly.
achieve this with layers removed during different stages
of the distribution process.

108
Storage between use Arrangements for any items contaminated with
When new garments are worn on every entry to the hazardous substances
cleanroom there is no requirement for storage between The risk of garments being contaminated in use with
use, the garments simply being placed in the soiled harmful chemical or biological substances will have
collection containers on exit from the cleanroom. been assessed by the cleanroom clothing team with
assistance from the Health and Safety department.
If cleanroom clothing is to be used more than once The type and quantity of contaminant will determine
it must be stored in a way which allows easy access the most appropriate disposal procedure required.
for the wearer and which minimises the risk of cross- This may range from incineration to separate bagging
contamination to the wearer, the clothing or the and labelling. All staff involved with wear, collection,
environment. transport and decontamination of such garments should
be fully aware of the procedures in place.
Garments are usually stored between use within the
cleanroom changing areas.
8.9
Simple pegs, individual lockers or special garment
Supply Options and Supplier Selection
storage cabinets with their own filtered-air supply are
examples of some of the storage options available. Once a clear picture of cleanroom clothing requirements
is established then the cleanroom clothing project team
Collection of soiled items and transfer to bulk must decide on the best supply options and the most
collection point suitable suppliers.
Contaminated clothing items are discarded by the
wearer after use. The collection facility for these items Whatever choices are made the full system must be
must be as easy to use as possible to allow the wearer in place before a cleanroom clothing programme (and
to quickly and efficiently dispose of soiled garments. therefore cleanroom production) can commence.
Overly complicated collection systems will often
result in misplaced garments and eventual shortages. The principle areas for decision are;
Simple collecting bins or boxes can be readily placed in
• Cleanroom clothing supply.
accessible positions and garment collection lockers can
also be easily accommodated in changing areas. • Cleanroom clothing distribution equipment and staff.
• Cleanroom clothing cleaning and decontamination.
On a regular basis the contaminated clothing is
• Combined supply.
collected and packed into bulk containers for the
scheduled collection by the garment decontamination
Cleanroom clothing supply
plant.
The manufacture and supply of cleanroom clothing is
arranged by many companies throughout the world.
Fabrics are sourced from specialist manufacturers
and supplied for make-up to contracted clothing
manufacturing companies.

The fabrics and garments offered by suppliers will

usually be of a standard range with full fabric and
garment specifications available to confirm their
suitability for cleanroom use. Samples for wearer trials
will be available to test comfort and fit.
Garment transport

109
If non-standard garments are required using unique Cleanroom clothing distribution equipment and staff
fabrics or styles then these must be developed in Distribution equipment can be tailor-made in house,
conjunction with the supplier and manufacturer before purchased or rented.
manufacture can commence.
Personal lockers, garment distribution lockers and
When a new fabric is developed then extensive collection lockers are all available from specialist
testing must be carried out by independent fabric test suppliers in a wide range of sizes, finishes and materials.
laboratories and this process may last for well over a They can have various locking options and can be built
year. into cleanroom changing areas to optimise the use of
space and facilitate easy cleaning.
Development of new cleanroom clothing can therefore
be a lengthy and costly process. Cleanroom compatible bins and racking are widely
available and can also be fabricated to meet individual
Direct purchase company requirements.
Cleanroom clothing can be directly purchased from
a supplier to match site requirements. When a new If cleanroom clothing distribution staff are required
cleanroom clothing programme is being initiated a large then these can be directly employed or supplied as
number of clothing items will be needed with multiple part of a full management package from the garment
new garment sets required for each wearer. This will decontamination supplier.
require a high capital outlay for the direct purchase.
As the garments are used replacements will be required Cleanroom clothing cleaning and decontamination
to cover damage or loss and additional garments may Full details of the cleanroom clothing decontamination
be required for new wearers, especially if a dedicated plant requirements are discussed in Section 6.0.
wearer system is adopted. The supply of these small Cleanroom Garment and Consumables Decontamination
numbers of garments can cause problems as garment - Plant and Process .
manufacturing plants operate most efficiently when
producing large quantities of the same garment. This process is a key service to cleanroom
manufacturing and a failure of supply will lead to
Garment rental disruption of cleanroom operations.
Cleanroom garment rental options remove many of the
financing and management problems associated with
direct garment purchase and are the usual choice for
obtaining garment supplies.

Charges are agreed for the contract term with the

clothing supplier who will source and stock and
maintain garments without a capital cost to the user.
Garment replacements and additions will be supplied
within an agreed timescale throughout the contract
period and an additional garment stock will be held by
the rental company for this purpose.
Cleanroom decontamination plant packing garments
Management of the cleanroom clothing manufacturing
chain will be the responsibility of the rental company
who will deal with fabric and garment manufacture,
exchange rate variance, shipping, import and quality
assurance.

110
 8.10
It is possible to set up an in-house laundry operating Implementation and Maintenance of the
at the required cleanroom standard and with adequate Clothing System
controls. In most instances the capital cost, complexity
and requirement for space and services means that Once the cleanroom clothing system has been agreed
this is not a realistic option however and a specialised and supply routes selected contracts can be signed and
external partner is usually contracted to supply this purchase orders issued.
service.
A programme must then be implemented to measure
As well as demonstrating full compliance with the the wearers, order fabric and garments, install
technical and quality assurance requirements of distribution equipment and carry out staff awareness
clothing decontamination any suitable supplier will also training.
be able to demonstrate a high level of customer service.
In addition a solid trading and financial background, Once garments have been manufactured and delivered
ethical sourcing policy and disaster recovery programme to the decontamination plant they can be inspected,
will give additional confidence in continuity of supply. labelled, decontaminated, packed, supplied and
distributed ready for first use.

Combined supply
Following the initial start-up customer support staff
Many purchasing departments prefer to optimise
provided by the supplier and internal staff will be
supply by using a limited number of suppliers. This
required to manage and monitor the first few days of
has many benefits in reducing costs for both customer
the new programme and ensure it is running smoothly.
and supplier and allowing higher volume purchasing
resulting in reduced unit pricing.
Once fully up and running the programme should then
continue to operate efficiently with periodic reporting
For this reason many suppliers have developed a “one-
and adjustments as required.
stop-shop” service to cover all aspects of cleanroom
clothing and consumables supply.
A good customer - supplier relationship can be
enhanced and monitored by periodic audits, service
Cleanroom garment supply, distribution, staff and
level measures, defined problem reporting procedures
equipment together with full garment cleaning and
and resolution systems.
decontamination services are available from single
suppliers with a range of charging options incorporating
With careful consideration of all requirements and a
both direct sale and rental.
full appraisal of the best supply options a cost effective
and wearer friendly cleanroom clothing system can be
Experienced suppliers can also provide valuable
implemented which efficiently meets the contamination
assistance in the development and implementation of a
control needs of the manufacturing operation.
cleanroom clothing programme from fabric and garment
selection through to equipment supply, staff training
and system start-up.

111
 SECTION

9.0
Planning, Sourcing and Optimising Cleanroom
Consumables Supply

Cleanroom manufacturing operations may need When producing documentation such as supplier
consumable products for a variety of reasons including agreements, validation protocols and work procedures
housekeeping and cleaning, as clothing, or as items of it is essential to use product specifications rather than
production equipment. proprietary brand names. This will provide a greater
degree of flexibility to use equivalent products which
Consumable products are usually single-use and meet the required specification, without significant
disposable, and so will generate a waste-stream which documentation changes.
will have ongoing costs associated with collection,
storage and disposal activities. This issue can be easily In order to clearly establish an accurate and
overlooked when selecting multipacked items. If a comprehensive specification for consumables it is
multipack contains far more items than will be used helpful to have input from a range of staff. These will
for the procedure e.g. a cleaning procedure using include those responsible for Purchasing, Production
impregnated wipes, then this will result in much of the Operations, Quality Assurance and Health and Safety.
consumable product being discarded unused and it will
often be more cost effective to select packs containing When product testing, validation and supplier audit is
smaller quantities with a higher unit cost but lower needed as part of the product selection process the
operational cost. time required to accommodate these stages should also
be taken into account .
Consumable items should only be chosen therefore
when no suitable re-usable alternative is available and It is likely that a range of products will be needed and
in the most economical quantities. it will usually be most efficient and cost effective to
source as many products as possible from a single
Many different disposable products are available and supplier.
these are discussed in detail in Section 5.0 Disposable
Contamination Control Clothing and Section 7.0 As the annual spend on consumables is likely to be
Cleanroom Cleaning - Methods and Equipment. a significant part of the whole cleanroom production
budget a careful assessment of actual requirements
The choice of product, cleanliness level, packaging and can be beneficial in achieving financial and efficiency
presentation will all affect the costs. It is very beneficial savings.
therefore to define the purpose and cleanroom
compatibility requirements for each consumable item There are various methods to identify consumable
and to produce a comprehensive product specification. products for a particular application and the simplest is
This will enable cost-effective products to be sourced to merely produce a list of currently purchased items.
which are fit for purpose and which meet the associated This is simple and quick, however no opportunities to
contamination control, regulatory and production assess product suitability, to consider alternatives or
requirements. to find significant savings will be possible using this
approach.

112
The most productive system is to use a simple Cleanroom consumables assessment check-list
assessment check-list which can be easily applied to
What is the function(s) of this consumable product?
any cleanroom consumable product.
Is there a re-usable alternative?
An example check-list is shown below however it is not What are the contamination control requirements of the
intended to be exhaustive and additional information area in which the consumable will be used?
may be needed in specific applications. Are there any registered regulatory authority
requirements?
For a small department this type of assessment will be Are there any Health and Safety considerations?
relatively easy; however for a larger operation, involving
Will the consumable item be required as PPE (personal
several production units, it will be more effective
protective equipment)?
to gather the information on a departmental basis
For consumable clothing items what range of sizes is
before collating the information into a total purchasing
needed?
requirement.
Are there any specific contamination control requirements
for the product being manufactured?
What level of particulate and fibre decontamination is
needed for the consumable product?
Will the consumable require ESD (electro-static discharge)
properties?
Does the consumable need to be sterile?
How does the consumable need to be packed or presented
to meet contamination control requirements and
operating procedures?
What product conformance documentation is required?
Are there any International or National standards or test
protocols against which the product must be tested?
What is the minimum shelf-life required?
How critical is this product to production continuity?
Does storage space or distribution to point-of-use present
any problems or require additional equipment?
Are adequate and acceptable disposal facilities in place for
the discarded consumable and its packaging?
Does the product need to be identified for use in a specific
area?
Can a consumable product’s design attributes be selected
to improve operational efficiency or safety?
Will product trials and/or validation be required?
What quantities of the consumable product are required
annually?
Are unusually large quantities of product needed at
specific times to meet peak requirements?
Is there a consumables budget?
At what date should supply commence?

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This check-list approach can be applied to any ABC pharmacy unit is manufacturing cytotoxic drug
cleanroom consumable product including clothing, doses.
cleaning products and production items such as
cleanroom paper. The manufacture requires aseptic technique in a Class II
Biological Safety Cabinet (GMP grade A).
Example of consumables assessment check-list in use
The following example shows how the completed The departmental standard operating procedures
check-list can be used to specify the correct product. require an inner and outer glove to be worn for this
procedure.
(It is often useful to provide this in a tabulated format
with each item numbered sequentially, with adjacent One member of staff undertakes this work and she has a
spaces for the responses and an additional column to possible allergy to Latex.
record any other comments or observations).
A branded glove (size 7) is currently being purchased
(Note; this example does not refer to any specific and has been in use for some time however a review of
operation). alternative products is now considered worthwhile.

ABC Pharmacy Unit

Assessment of outer glove requirements for use in cytotoxic drug production

What is the function(s) of this consumable product?

Outer glove for the aseptic manufacture of cytotoxic drugs.

Is there a re-usable alternative?

No.

What are the contamination control requirements of the area in which the consumable will be used?
Class II Biological Safety Cabinet GMP class A.

Are there any registered regulatory authority requirements?

Gloves not included in the product registration document.

Are there any health and safety considerations?

Yes - danger of skin exposure to cytotoxic drug. Possible latex allergy.

Will the consumable item by required as PPE (personal protective equipment)?

Yes - risk assessment requires the gloves to act as PPE.

For consumable clothing items - what range of sizes is needed?

Size 7.0 only.

Are there any specific contamination control requirements for the product being manufactured?
Product must be protected from particulate, microbiological and endotoxin contamination.

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What level of particulate and fibre decontamination is needed for the consumable product?
Compatible with ISO 14644-1 grade 5 cleanroom, GMP class A.

Will the consumable require ESD (electro-static discharge) properties?

No.

Does the consumable need to be sterile?

Yes.

How does the consumable need to be packed or presented to meet contamination control requirements and operating procedures?
Hand specific, presented individually packed and double bagged for aseptic donning.

What product conformance documentation is required?

Certificate of irradiation, batch conformance analysis test results.

Are there any International or National standards or test protocols against which the product must be tested?
Tested in accordance with BS EN 420:2003, PPE category III product, tested in accordance with EN 374:2003 part 2 and 3,
Meets or exceeds AQL level of 1.5 for pinholes, tested to show low endotoxin level (≤20 EU per pair), tested to show low
particulate level. Tested to show acceptably low permeation to cytotoxic drugs.

What is the minimum shelf-life required?

Two years.

How critical is this product to production continuity?

Critical - production cannot proceed without these gloves.

Does storage space or distribution to point-of-use present any problems or require additional equipment?
No - existing adequate storage and distribution system.

Are adequate and acceptable disposal facilities in place for the discarded consumable and its packaging?
Yes - existing procedures and equipment in place for correct disposal of discarded “clean” or accidentally contaminated
gloves and packaging.

Does the product need to be identified for use in a specific area?

Yes - for use in cytotoxic drug production only.

Can a consumable product’s design attributes be selected to improve operational efficiency or safety?
Yes - gloves must provide easy donning and good operational dexterity. Glove must be long enough to overlap garment
cuff. Colour must contrast with inner glove colour.

Will product trials and/or validation be required?

Yes - operational trial.

115
 What quantities of the consumable product are required annually?
Approximately 3,000 pairs (gloves changed every 30 minutes).

Are unusually large quantities of product needed at specific times to meet “peak” requirements?
No, regular usage throughout year.

Is there a consumables budget?

Yes.

At what date should supply commence?

3 months supply currently in stock.

From this information a product specification can be produced for this glove.
A suggested example is shown below.

ABC Pharmacy
Consumable Product Specification # GLV-123 - powder-free cleanroom outer glove for use in cytotoxic drug production

Product Powder-free cleanroom outer glove for use in cytotoxic drug production unit
Material Nitrile
Size 7.0
Cuff length 30cm
Colour White
Packaging and presentation Hand specific, double bagged, packed as pairs for aseptic donning
Sterility Sterile, with minimum two years shelf life
Contamination control standard Suitable for use in ISO 14644-1 grade 5, EU GMP grade A / B environment
Glove conformance tests required Tested in accordance with BS EN 420:2003
PPE category III product - CE marked
Tested in accordance with EN 374:2003 part 2 and 3
Meets or exceeds AQL level of 1.5 for pinholes
Tested to show low endotoxin level (≤20 EU per pair)
Tested to demonstrate low particulate level
Tested to show acceptably low permeation to cytotoxic drugs
Batch documentation Batch conformance documentation and irradiation certificate to be supplied for
each numbered batch

Requirements may change over time e.g. an alternative Once this assessment has been carried out for each
glove size may be required, however any changes to disposable product and the product specifications
the generic specification can be easily accomplished produced appropriate suppliers can be contacted and
using the document control procedures of a Quality the full consumables requirement discussed in detail.
Management System. As well as the product specification additional
information from the check-list such as annual
quantities, any distribution equipment needed and
timescales will all be valuable in the sourcing process.

116
Suppliers will wish to suggest various product options
which meet the specification and it is usual for samples
to be provided free-of-charge so that trials can be
carried out and the products assessed by the relevant
departments.

Glove samples with full supporting documentation for assessment

It is usually more cost effective to select an existing

off-the-shelf product. However when no product can
be sourced which meets the specification suppliers
will consider developing products for a particular
application. Development of unique products will
increase sourcing timescales and may require a
commitment to purchase significant quantities of the
product

As the majority of consumable products are

manufactured overseas, supply chain security, ethical
sourcing policy, product stockholdings and delivery
frequency will need to be assessed and this can often
be accomplished during a supplier audit. Whenever
possible it is usually beneficial to source all cleanroom
consumable products from a one-stop-shop supplier
although an alternative supplier may be needed as a
back-up for critical products.

Once suitable and acceptable products have been

identified the different supplier options can be assessed
and supply arrangements finalised.

The flowchart shows this basic assessment and

purchasing system for 5 consumable products. They
are used in two separate cleanroom manufacturing
operations within the same organisation, which has a
central purchasing department.

117
 CACL CACL CACL CACL CACL

PS PS PS PS PS

PURCHASE ORDER

Cleanroom consumables purchasing flow chart

118
 SECTION

10.0
Acknowledgements, References, Useful Contacts
and Sources of Information

Acknowledgements Tables adapted and reprinted from IEST-RP-CC003 with

The following books have been especially useful in permission from the Institute of Environmental Sciences
providing valuable information for the Micronclean Big and Technology (IEST). Copyright by IEST, www.iest.org
Blue Cleanroom Handbook:
Table showing recommended limits for microbial
Cleanroom Technology - Fundamentals of Design Testing contamination is reprinted from Rules and Guidance for
and Operation - W. Whyte, Second edition, Published Pharmaceutical Manufacturers and Distributors 2007
2010 by John Wiley & Sons Ltd. with the permission of the Medicines and Healthcare
Products Regulatory Agency
Cleanroom Clothing Systems: People As a Contamination www.mhra.gov.uk
Source - B. Ljungqvist and B. Reinmuller, Published 2004
by PDA/DHI. References
Section 2
Production of diagrams and assistance in the Graphic 1
Design of the Micronclean Big Blue Cleanroom Federal Standard 209. This standard was first
Handbook has been provided by Ellis Grange - published in 1963 titled “Cleanroom and Work Station
[email protected] Requirements, Controlled Environments”. It was revised
in 1966 (209A), 1973 (209B), 1987 (C), 1988 (D) and
Some photographs courtesy of Jack Grange 1992 (E).
www.jackgrange.co.uk
2
BS 5295 British Standard 5295:1989
The British Standard contained five parts.
Copyright permission
Permission to reproduce extracts from BS EN ISO Part 0 - General introduction and terms and definitions
14644-1:1999 is granted by BSI. No other use of this for clean rooms and clean air devices.
material is permitted. British Standards can be obtained Part 1 - Specification for clean rooms and clean air
in PDF or hard copy formats from the BSI online shop: devices.
www.bsigroup.com/Shop or by contacting BSI Customer Part 2 - Method for specifying the design, construction
Services for hard copies only: Tel: +44 (0)20 8996 9001, and commissioning of clean room and clean air devices.
Email: [email protected] Part 3 - Guide to operational procedures and disciplines
applicable to clean rooms and clean air devices.
The garment cleanliness classification table from ASTM Part 4 - Specification for monitoring clean rooms and
F51-00(2007) is reprinted, with permission, from ASTM clean air devices to prove continued compliance with BS
F51-00(2007) Standard Test Method for Sizing and 5295
Counting Particulate Contaminant In and On Clean
Room Garments, copyright ASTM International, 100 Barr
Harbor Drive, West Conshohocken, PA 19428.

119
3 7
BS EN ISO 14644-1:1999 Cleanrooms and associated BS 6524:1984 - Method for the determination of the
controlled environments. Classification of air cleanliness. surface resistivity of a textile fabric.
BS EN ISO 14644-2:2000 Cleanrooms and associated
controlled environments. Specifications for testing and 8
monitoring to prove continued compliance with ISO IEST-RP-CC003: Garment System Considerations for
14644-1. Cleanrooms and Other Controlled Environments.

BS EN ISO 14644-3:2005 Cleanrooms and associated 9

controlled environments. Test Methods. ASTM F51-00 (2007) Standard Test Method for Sizing
BS EN ISO 14644-4:2001 Cleanrooms and associated and Counting Particulate Contaminant In and On Clean
controlled environments. Design, Construction and Room Garments.
Start-up.
BS EN ISO 14644-5:2004 Cleanrooms and associated 10
controlled environments. Operations. BS EN 14065:2002 Textiles - Laundry processed textiles
- Biocontamination control system.
BS EN ISO 14644-6:2007 Cleanrooms and associated
controlled environments. Vocabulary.
BS EN ISO 14644-7:2004 Cleanrooms and associated Section 3
controlled environments. Separative devices (clean air 1
hoods, gloveboxes, isolators and mini environments. IEST-RP-CC003: Garment System Considerations for
Cleanrooms and Other Controlled Environments.
BS EN ISO 14644-8:2006 Cleanrooms and associated
controlled environments. Classification of airborne
2
molecular contamination.
BS EN ISO 14644-1:1999 Cleanrooms and associated
BS EN ISO 14644-9 Cleanrooms and associated controlled environments. Classification of air cleanliness.
controlled environments. Classification of surface
particle cleanliness (08/30190157 DC draft for public 3 The MHRA
comment published Sept 2008). Rules and Guidance for Pharmaceutical Manufacturers
and Distributors 2007.
4 The MHRA
Rules and Guidance for Pharmaceutical Manufacturers
and Distributors 2007.

5
ISO 14698-1 Cleanrooms and associated controlled
environments - Biocontamination control.
Part 1 General principles and methods.
ISO 14698-2 Cleanrooms and associated controlled
environments - Biocontamination control.
Part 2 Evaluation and interpretation of biocontamination
data.

6
BS EN 61340-5-1:2007– Electrostatics Protection of
electronic devices from electrostatic phenomena.
General requirements

120
Section 4 Section 5
1 1
BS 3321:1986 Method for measurement of the Personal Protective Equipment Directive 89/686/EEC.
equivalent pore size of fabrics (bubble pressure test).
2
2 BS EN 943-1:2002
British Textile Technology Group (BTTG) Particle Barrier Protective clothing against liquid and gaseous
Efficiency Test . chemicals, aerosols and solid particles. Performance
requirements for ventilated and non-ventilated “gas-
3
tight” (Type 1) and “non-gas-tight” (Type 2) chemical
BS 6909:1988 Method for generation and counting of
protective suits.
the airborne linting propensity of fabrics in the dry state.

4 BS EN 14605:2005+A1:2009
ASTM E96/E96M-10 Standard test methods for water Protective clothing against liquid chemicals.
vapour transmission of materials. Performance requirements for clothing with liquid-tight
(Type 3) or spray-tight (Type 4) connections, including
5 items providing protection to parts of the body only.
BS EN ISO 9237:1995 Textiles. Determination of the
permeability of fabrics to air. BS EN ISO 13982-1:2004+A1:2010
Protective clothing for use against solid particulates.
6
Performance requirements for chemical protective
BS EN 1149-1:2006 Protective clothing. Electrostatic
clothing providing protection to the full body against
properties. Test method for measurement of surface
airborne solid particulates (Type 5).
resistivity.

BS EN ISO 13982-2:2004
7
Protective clothing for use against solid particulates. Test
BS EN 530:2010 Abrasion resistance of protective
method of determination of inward leakage of aerosols
clothing material. Test methods.
of fine particles into suits.

8
BS EN 13034:2005+A1:2009
IEST-RP-CC003: Garment System Considerations for
Protective clothing against liquid chemicals.
Cleanrooms and Other Controlled Environments.
Performance requirements for chemical protective
clothing offering limited protective performance against
9
liquid chemicals (Type 6).
Whyte W. Dispersion of particles and micro-organisms
from people. European Journal of Parenteral and
3
Pharmaceutical Sciences 2007; 12(2): 39-46
Eaton T. A safe pair of hands - how secure are your
gloves used for aseptically prepared pharmaceutical
products? European Journal of Parenteral and
Pharmaceutical Sciences 2005; 10(3): 35-42.

4
BS EN 455-1:2000. Medical gloves for single use:
Requirements and testing for freedom from holes.

5
BS EN 420:2003+A1:2009 Protective gloves. General
requirements and test methods.

121
6 Section 7
BS EN 374-1:2003 Protective gloves against chemicals 1
and micro-organisms. Terminology and performance BS EN ISO 14644-5:2004 Cleanrooms and associated
requirements. controlled environments. Operations.

BS EN 374-2:2003 2
Protective gloves against chemicals and micro- Eaton T. Cleanroom Airborne Particulate Limits and
organisms. Determination of resistance to penetration. 70% Isopropyl Alcohol (IPA)–a Lingering Problem for
Pharmaceutical Manufacturing? PDA Journal, 2009.
BS EN 374-3:2003
Protective gloves against chemicals and micro- 3
organisms. Determination of resistance to permeation BS EN 1276:2009 Chemical disinfectants and
by chemicals. antiseptics. Quantitative suspension test for the
evaluation of bactericidal activity of chemical
7 disinfectants and antiseptics used in food, industrial,
IEST-RP-CC005: Gloves and Finger Cots Used in domestic, and institutional areas. Test method and
Cleanrooms and Other Controlled Environments. requirements.

4
Section 6 CEN EN 13697:2001 Chemical disinfectants and
1 antiseptics. Quantitative non-porous surface test for the
BS EN ISO 14644-1:1999 Cleanrooms and associated evaluation of bactericidal and/or fungicidal activity of
controlled environments. Classification of air cleanliness. chemical disinfectants used in food, industrial, domestic
and institutional areas. Test method and requirements
2 The MHRA without mechanical action (phase 2/step 2).
Rules and Guidance for Pharmaceutical Manufacturers
and Distributors 2007. 5
BS EN 1650:2008 Chemical disinfectants and
3 antiseptics. Quantitative suspension test for the
IEST-RP-CC003: Garment System Considerations for evaluation of fungicidal or yeasticidal activity of
Cleanrooms and Other Controlled Environments. chemical disinfectants and antiseptics used in food,
industrial, domestic and institutional areas. Test method
4 and requirements (phase 2, step 1).
ASTM F51-00 (2007) Standard Test Method for Sizing
and Counting Particulate Contaminant In and On Clean 6
Room Garments. BS EN 13704:2002 Chemical disinfectants. Quantitative
suspension test for the evaluation of sporicidal activity
5 of chemical disinfectants used in food, industrial,
HSG (95)18: Hospital laundry arrangements for used domestic and institutional areas. Test method and
and infected linen. requirements (phase 2, step 1).

6
ISO 11137-2:2006 Sterilisation of healthcare products.

7
BS EN 1149-1:2006 Protective clothing. Electrostatic
properties. Test method for measurement of surface
resistivity.

122
Useful Contacts and Sources of Information

British Standards Institution www.bsigroup.com BTTG - The British Textile Technology Group
BSI Group provides a range of services; www.bttg.co.uk
develops private, national and international standards, BTTG was founded 1989 by the merger of the Shirley
certifies management systems and products, Institute and Wool Industry Research Association, with
provides testing and certification of products and histories stretching back 85 years.
services, provides training and information on standards
and international trade and provides performance The Group has two operating companies :
management and supply chain management software BTTG Testing & Certification specialises in the testing
solutions. and Certification of Personal Protective Equipment,
Geosynthetics, Floorcoverings and other construction
ISO - International Organisation for Standardisation products. It offers Certification to EU Directives.
www.iso.org Shirley Technologies provides a broad range of services
ISO is a non-governmental organisation comprising a to the traditional apparel sector. It specialises in
network of the national standards bodies of some 160 chemical testing and provides certification to the Oeko-
countries, one per country, from all regions of the world. tex scheme.
Each ISO member is the principal standards organisation
in its country. The members propose the new standards, IEST -The Institute of Environmental Sciences and
participate in their development and provide support Technology www.iest.org
in collaboration with ISO Central Secretariat for IEST is an international, technical society of engineers,
nearly 3,280 technical groups that actually develop scientists, and educators that serves its members
the standards. When their work is published as an and the industries they represent (simulating, testing,
ISO International Standard, it may be translated and controlling, and teaching the environments of earth
adopted as a national standard by the ISO members. and space) through education and the development of
recommended practices and standards.
ASTM www.astm.org
Pharmaceutical and Healthcare Sciences Society
ASTM International (ASTM), originally known as the
www.phss.co.uk
American Society for Testing and Materials, is an
The Pharmaceutical and Healthcare Sciences Society
international standards organisation that develops and
exists as a science based forum for individuals active in
publishes voluntary consensus technical standards
the fields of Pharmaceutical and Healthcare Sciences.
for a wide range of materials, products, systems, and
The society evolved from the former Parenteral Society,
services. The organisation’s headquarters is in West
which was primarily focused on sterile injectable and
Conshohocken, Pennsylvania, USA.
implantable drugs and devices.

ASTM, founded in 1898, pre-dates other standards

organisations but differs from these in that it is not a
MHRA - The Medicines and Healthcare Products
national standards body, (that role being taken in the
Regulatory Agency www.mhra.gov.uk
United States by ANSI). However, ASTM has a dominant
The MHRA was set up in April 2003 from a merger of
role among standards developers in the USA, and claims
the Medicines Control Agency and the Medical Devices
to be the world’s largest developer of standards.
Agency. The MHRA is the government agency which is
responsible for ensuring that medicines and medical
devices work, and are acceptably safe. The MHRA is an
executive agency of the Department of Health.

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