Cleanroom Construction and Materials

Fabtec Training 23 to 25 June 2016
Hotel Park View Mumbai

[email protected]
+919820698100
CLEANROOM
CONSTRUCTION AND
MATERIALS
1
Documentation Requirements
Any Document can have errors or oversight. In
commercial invoices, on a corner, they write: E & O E.

Do you know what is this?
Can we write E & O E after your Design Specifications
documents?
It is, hence, important to select appropriate materials
for construction of your cleanrooms. It will help you

avoid non-compliance from GMP point of view later.
2
In order to make people understand the importance of Quality by
Design (QbD) , one of the impressive method adopted by Russian Tsar
Peter the Great in 1706 was a decree:
All projects shall be done in a very good order so as not to ruin
the treasure in vain and not to cause harm to the fatherland. Ill
deprive of the rank and will bid to flog with a whip all those who
will fudge projects anyhow
These words are valid today too. Our roads, runways, buildings, and
other infrastructure projects are lacking in quality not because of

technological scarcity.
It is simply our callousness in getting into details while designing which
gets us into trouble later.
Construction of an installation shall comply with the
drawings and specifications

Any changes required during the course of construction
shall be checked for acceptance, approved and documented

prior to implementation of the change in accordance with a
change control procedure.
Construction work, whether performed at a manufacturing
site or in situ, shall observe the specific contamination

control requirements of the quality plan.
4
A clean construction protocol and cleaning procedures
shall be developed as part of the quality plan and enforced

to achieve the specified contamination control
requirements.
Security and access control is required and essential to
maintain the clean construction protocol.
The cleaning of the air systems shall be specified and shall
be carried out at the assembly, before initial operation and

whenever rebuilding work, repair work and maintenance
work are performed. All such procedures shall be
documented.
5
Selection Of Materials
The materials used in the construction of the installation
should be selected and applied to meet the requirements of
the installation and should take into account the following:
The Cleanliness class
Effects of abrasion and impact

Cleaning and disinfection methods and frequencies
Chemical/microbiological attack and corrosion
6
Materials which may tend to breakdown or to shed
particles should only be used when they are effectively

encapsulated and protected.
Consideration should be given to the chemical
compatibility of all materials used with the operating

requirements of the installation.
This may, for instance, influence the choice of adhesives
and sealing mastics for surface-finishing work, or of

materials used for filter assembly and sealing.
7
All surfaces which come into contact with air supplied to the
interior of the cleanroom or clean zone may by their nature or

condition influence the quality of the air supplied to the
contamination-sensitive zones.
For this reason, materials and finishes intended for the internal
surfaces of the complete air handling system should be critically

assessed and specifically approved for this purpose.
All exposed surfaces of equipment, furnishings and materials
present in the cleanroom or clean zone should meet the same

criteria as the exposed structural elements of the installation.
Surface Cleanliness and Clean-ability

of Materials of Construction
All exposed materials shall be suitable for effective
and frequent cleaning and disinfection, and should
not:
Offer surface asperities or porosity which are likely to
allow retention of particulate, and/or chemical

contamination.
Allow development of microbiological contamination.
9
Surface Cleanliness and Clean-ability

of Materials of Construction
The interior surfaces of a controlled environment should
be accessible for cleaning and these include:
a. Walls
b. Floors
c. Ceilings
d. Doors
e. Inlet side of air diffusers or grilles
f.
Floor drains
10
Control of Electrostatic charge and

discharge
Accumulation of electrostatic charge and subsequent
discharge can present a risk of hazards such as:
Explosion in the presence of powders and gases
Device damage to electronic or optical components

Excessive attraction of particles to surfaces
contributing to physical, chemical and microbiological

contamination
11

discharge
Where the above risks cause concern, materials used in
construction should neither generate nor hold a significant static

charge.
This significant value should be specific to each application and
should be clearly specified by the purchaser in the URS.
Certain processes may require particular conditions in terms of
environmental humidity but for minimizing generation of

electrostatic charge, relative humidity requirements shall be
contradictory.
Certain application may require conductive or static dissipative
materials in order to minimize induced static charge.
12

discharge
To protect against these hazards, following parameters need be
studied, agreed upon with purchaser and documented:
Resistance to earth
Site transition resistance
Mass resistance
Earthing
The required electrical characteristics for flooring are valid for
the entire structure or composite of materials used as a floor and
should be monitored regularly for potential loss of performance
due to ageing.
13
Internal finishes, durability and

maintainability:
In the completed installation, all internal surfaces should
be finished suitably smooth, non-porous and free from

cracks, cavities, steps and ledges.
Number of corners and junctions should be minimized and
unavoidable ones like wall to wall and wall to

floors/ceilings should be radiused (covings).
Regular maintenance procedures, repair methods,
disruption impact, full life cycle cost and contamination

risk analysis should form part of material selection
criteria.
14
Considerations for Specific

Components
Ceilings, walls and floors: Basic requirements should
be to comply with relevant regulations concerning fire

protection, sound and thermal insulation.
Surface finish and assembly details shall comply with
cleaning and disinfection protocols.

In order to avoid glare, surface color and finish should
be compatible with intended lighting conditions.

15

Components
Ceilings, Walls and Floors
Can be made with following options:
a.
b.
c.
d.
e.
f.
Wet construction and applied surface finish

Dry construction and applied surface finish
Pre-finished engineered components
Modular pre-finished panel systems
Floors or floor coverings should be non-porous, slip resistant, conductive if
necessary, resistant to the chemicals used for disinfection and should
support the static and dynamic loads with the required durability.
Combinations of above
MOC can be PCGI, PPGI, Stainless Steel, Plastic laminates, FGRP, Glass, PVC
and/or combination of all.
16

Components
Ceilings
a. MOC and construction can be the same as above.
b. Should be sealed
c. Should accommodate filter housings, light diffusers,
utility services
d. Fire safety systems
17

Components
Air Handling Units/Systems (AHUs)
a.
Minimize contamination generated, retained and released

throughout the air handling system in all components and surfaces
in contact with the system air to reduce excessive load on the
filtration system.
b.
Ducts should be manufactured from materials with corrosionresistant and non-flaking properties or should be given proper
surface treatment to prevent release of contaminants into air
streams.
c.
It is better to have appropriate terminal filter/s in cleanrooms than

having final filter/s inside the AHU. This prevents clean air from
passing through dirty duct surfaces.
18

Components
Ducting why are they called dirty?
a.
Apart from what is mentioned above, it should be appreciated

that all filters used in the Air Handling Systems are efficiency
devices.
b.
Filters are nothing but a controlled leak.
c.
Particle laden air, while passing through ducts, allows particles

to adhere to surfaces, agglomerate, coalesce and helps in
forming a fine layer of dust on passage of time.
d.
So, when Final filters are fitted inside AHUs, the clean air
passes through dirty duct lengths leading to sporadic release of
particles into clean rooms.
19

Components
Fittings in Change rooms and Air locks
a.
Gowning rooms should present as few horizontal surfaces as possible
b.
Hanging rails and perforated shelf boards rather than closed lockers
can be considered
c.
Exposed surfaces should satisfy same criteria of cleanroom interiors
d.
Garment storage cubicles with or without filters and UV lights are

used extensively, but their usage should be studied carefully and
agreed in advance with the quality team
e.
Fresh clean/sterile garments are recommended for each work session

and re-use of garments can pose contamination risks
20

Components
Ancillary areas
a. Should not have direct connections to cleanrooms
except for emergency exits

b. Materials entry/exit should be through appropriate
air locks or pass boxes

c. Exposed surfaces in these areas also should consider
durability and ease of maintenance.

21

Components
Construction and assembly
Build it clean, maintain it clean and use it clean should be the motto
Many tasks involved in construction and assembly intrinsically generate

contamination
Clean construction protocol should be developed and enforced.
Use temporary screens and walls and pressurize critical zones, if possible
Provide sacrificial filters in the AHUs for initial use and then replace them
with actual ones
Continual and frequent cleaning should be planned to avoid undue buildup of
contaminants and debris.
22
Conclusion
ISO 14644 part 4 specifies the requirements for the design and
construction of cleanrooms but does not prescribe specific

technological or contractual means to meet these requirements
Construction guidance is provided including requirements for start-up
and qualification.
Basic elements are identified

Under clause 4 Requirements, sub-clause 4.1 says, The
parameters listed in 4.2 to 4.18 shall be defined and agreed

between purchaser and supplier !!!!!!
There is also a NOTE: In the requirements stated below, references
are made to annexes A to H which are for information only
23
Take away..
Design Clean, Construct Clean and Operate Clean
Use materials which dont shed particles and retain
contamination
Cleanabilty of components while selecting MOC is of
paramount importance
Use common sense, which is not common
24

Cleanroom Construction and Materials

Uploaded by

Copyright:

Available Formats

Cleanroom Construction and Materials

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Cleanroom Construction and Materials

Uploaded by

Copyright:

Available Formats

What documentation requirements must be followed during cleanroom construction?

What documentation requirements must be followed during cleanroom construction?

What factors must be considered when selecting materials for cleanroom construction?

What factors must be considered when selecting materials for cleanroom construction?

Fabtec Training 23 to 25 June 2016

Hotel Park View Mumbai

commercial invoices, on a corner, they write: E & O E.

for construction of your cleanrooms. It will help you

other infrastructure projects are lacking in quality not because of

It is simply our callousness in getting into details while designing which

gets us into trouble later.

drawings and specifications

shall be checked for acceptance, approved and documented

site or in situ, shall observe the specific contamination

shall be developed as part of the quality plan and enforced

Security and access control is required and essential to

maintain the clean construction protocol.

The cleaning of the air systems shall be specified and shall

be carried out at the assembly, before initial operation and

Effects of abrasion and impact

particles should only be used when they are effectively

compatibility of all materials used with the operating

and sealing mastics for surface-finishing work, or of

interior of the cleanroom or clean zone may by their nature or

surfaces of the complete air handling system should be critically

present in the cleanroom or clean zone should meet the same

Surface Cleanliness and Clean-ability

allow retention of particulate, and/or chemical

Surface Cleanliness and Clean-ability

Control of Electrostatic charge and

Device damage to electronic or optical components

contributing to physical, chemical and microbiological

Control of Electrostatic charge and

construction should neither generate nor hold a significant static

This significant value should be specific to each application and

should be clearly specified by the purchaser in the URS.

Certain processes may require particular conditions in terms of

environmental humidity but for minimizing generation of

Certain application may require conductive or static dissipative

materials in order to minimize induced static charge.

Control of Electrostatic charge and

Internal finishes, durability and

be finished suitably smooth, non-porous and free from

unavoidable ones like wall to wall and wall to

disruption impact, full life cycle cost and contamination

Considerations for Specific

be to comply with relevant regulations concerning fire

cleaning and disinfection protocols.

be compatible with intended lighting conditions.

Considerations for Specific

Wet construction and applied surface finish

Considerations for Specific

Considerations for Specific

Minimize contamination generated, retained and released

It is better to have appropriate terminal filter/s in cleanrooms than

Considerations for Specific

Apart from what is mentioned above, it should be appreciated

Filters are nothing but a controlled leak.

Particle laden air, while passing through ducts, allows particles