1.

Abstract
Aseptic gowning is an essential part of contamination prevention the correct aseptic gowning
procedures are of utmost importance to ensure a safe and compliant operation in the cleanroom
environment. Aseptic gowning one of the main considerations for biopharmaceutical
manufacturing processes, here we will discuss Cleanrooms for sterile pharmaceutical industry,
Classification of clean areas, Clean Area Separation, Aseptic gowning, Appropriate gowning,
Gowning room, General choice of cleanroom gowning, Classification of gowning required for
clean areas, Cleanroom gowns, Gowning procedure for clean areas.
ASEPTIC GOWNING TECHNIQUEES

Submitted by:
Maysoun Bali
Asma alsharabati
 Aseptic gowning techniques
Table of content

Table of content.................................................................................1
1. Abstract........................................................................................1
2. Introduction...................................................................................1
3. Cleanrooms for sterile pharmaceutical industry.........................................2
3.1. International Standards for clean rooms.................................2
3.2. Classification of clean areas................................................2
3.3. Clean Area Separation.......................................................3
4. Aseptic gowning...............................................................................4
4.1. Centralized vs. decentralized..............................................4
4.2. Appropriate gowning.........................................................4
4.3. Gowning inconsistency......................................................5
5. Gowning rooms................................................................................5
5.1. General choice of cleanroom gowning....................................6
5.2. Classification of gowning required for clean areas.....................6
5.3. Cleanroom gowns............................................................7
5.4. Cleanroom gowning procedures in general...............................8
5.5. Gowning procedure for clean areas......................................11
5.6. Key garmenting guidelines:...............................................13
6. Conclusion....................................................................................13
7. References...................................................................................14

1. Abstract cleanroom gowning, Classification of

gowning required for clean areas,
Aseptic gowning is an essential part of
Cleanroom gowns, Gowning procedure for
contamination prevention the correct
clean areas.
aseptic gowning procedures are of utmost
importance to ensure a safe and compliant
operation in the cleanroom environment. 2. Introduction
Aseptic gowning one of the main The control of the environment around
considerations for biopharmaceutical biologics manufacturing has historically
manufacturing processes, here we will been a key consideration for the design
discuss Cleanrooms for sterile and operation of bioprocessing facilities to
pharmaceutical industry, Classification of ensure product quality and safety. Facility
clean areas, Clean Area Separation, design and control considerations for
Aseptic gowning, Appropriate gowning, commercial biopharmaceutical
Gowning room, General choice of manufacturing processes include
environmental controls (e.g., temperature, Standard 209 4 was fixed and named
humidity, and pressure), air quality (e.g., 209A. Afterwards every following
particulate and microbiological), facility revising was given letters in alphabetical
finishes, gowning and flow procedures, order: 1973 (B), 1987(C), 1988 (D) and
equipment containment, system integrity, 1992 (E). [1][2][3]
and cleaning procedures.
ISO – The International Organization for
The most widely adopted room Standards published in 1999 ISO-14644-1
classifications in use today range from standard which officially replaced Federal
grade A/ISO 5 (dynamic) through grade Standard 209. This ISO was named
D/ISO 8 (static) based on the perceived “Cleanrooms and Associated Controlled
risk of environmental contamination to the Environments”. It is used in all European
process step. Union and also some other countries. IEST
– The Institute of Environmental Sciences
3. Cleanrooms for sterile and Technology works out the standard to
connect all cleanroom requirements all
pharmaceutical industry over the world and published other parts
Cleanroom is a controlled placement which are: 14644-2 (2000), 14644-4
where different products are (2001), 14644- 5 (2004), 14644-7 (2004),
manufactured. And the concentration of 14644- 8 (2006), 14644- 9 (Draft
airborne particles is controlled, and which International Standard). [4][5]
is constructed and used in a manner to
minimize the introduction, generation, and Today there are standards: 1. ISO 14644 -
retention of particles inside the room and standard for Airborne Particulate
in which other relevant parameters, e.g. Cleanliness Classes in Cleanrooms and
temperature, humidity, and pressure, are Clean Zones 2. ISO 14698, Cleanrooms
controlled as necessary.[1] and associated controlled environments –
Biocontamination control.[5]
3.1. International Standards for
clean rooms 3.2. Classification of clean areas

Cleanrooms are classified by the Clean areas for the manufacture of sterile
cleanliness of air. Standards are very products are classified according to the
important in designing process. Their required characteristics of the
using increase levels of safety, reliability, environment. Each manufacturing
quality and efficiency. The history of operation requires an appropriate level of
cleanroom standards started in the USA. environmental cleanliness in the
By order of American Air Force first operational state to minimize the risks of
standard was made in 1961. It was called particulate or microbial contamination of
Technical Manual 00-25-203. There was the product or materials being handled.[6]
description of entering, designing and
For the manufacture of sterile
cleaning. Also it involves airborne particle pharmaceutical preparations, four grades
requirements. Two years later was
of clean areas are distinguished as follows:
published Federal Standard 209. It is the
first document that regulates cleanroom Grade A: The local zone for high-risk
facilities. It was entitled "Clean Room and operations, e.g. filling and making aseptic
Work Station Requirements, Controlled connections. Normally such conditions are
Environments". There was determined achieved by using a unidirectional airflow
measured size of particle more than workstation. Unidirectional airflow
0.5µm. It was so, because there was not systems should provide a homogeneous air
better equipment to measure smaller speed of 0.36–0.54 m/s (guidance value) at
particles at those days. In 1966 Federal a defined test position 15–30 cm below the
terminal filter or air distributor system. produce a consistent and controlled
The velocity at working level should not environment. CNC space is cleanable,
be less than 0.36 m/s. The uniformity and access controlled, and served with filtered
effectiveness of the unidirectional airfl ow ventilation air.
should be demonstrated by undertaking
A unidirectional airflow and lower
airflow visualization tests.[7][8][1]
velocities may be used in closed isolators
• Grade B: In aseptic preparation and and glove boxes. In order to reach the B, C
filling, this is the background environment and D air grades the number of air changes
for the Grade A zone. should be appropriate for the size of the
room and the equipment and personnel
• Grades C and D: Clean areas for
present in it.[9][10]
carrying out less critical stages in the
manufacture of sterile products or carrying Classification should be clearly
out activities during which the product is differentiated from operational process
not directly exposed (i.e. aseptic environmental monitoring. The maximum
connection with aseptic connectors and permitted airborne particle concentration
operations in a closed system). for each grade is given in Table 1.[11]
• Controlled not classified (CNC): A
cGMP manufacturing area designed to

Maximum permitted number of particles per m3 greater than or equal to

the tabulated size
At rest a In operation b
Grade 0.5 µm 5.0 µm 0.5 µm 5.0 µm

A 3 520 20 3 520 20

B 3 520 29 352 000 2 900

C 352 000 2 900 3 520 000 29 000

D 3 520 000 29 000 Not defined Not defined

Table 1. The maximum permitted airborne particle concentration for each grade.

The “at rest” state is the condition where systems should be designed to achieve
the installation is complete with equipment both the “at rest” and “in operation” states.
installed and operating in a manner agreed
 In order to reach the B, C and D air
upon by the customer and supplier, but
grades, the number of air changes should
with no personnel present.
be related to the size of the room and the
The “in operation” state is the condition equipment and personnel present in the
where the installation is functioning in the room. The air system should be provided
defined operating mode and the specified with appropriate filters such as HEPA for
number of personnel is present. The areas grades A, B and C.[12][7]
and their associated environmental control
3.3. Clean Area Separation
An essential part of contamination emitted from your body do not
prevention is the adequate separation of contaminate the environment.[15][16]
areas of operation. To maintain air quality,
Correct aseptic gowning procedures are of
it is important to achieve a proper airflow
utmost importance to ensure a safe and
from areas of higher cleanliness to
compliant operation in the cleanroom
adjacent less clean areas. It is vital for
environment. Particulate is difficult to
rooms of higher air cleanliness to have a
detect because it is invisible to the naked
substantial positive pressure differential
eye. Contamination is commonly
relative to adjacent rooms of lower air
introduced to the cleanroom environment
cleanliness. For example, a positive
through the people who enter the
pressure differential of at least 10-15
cleanroom. Therefore, it is extremely
Pascal’s (Pa) should be maintained
important that cleanroom operators have
between adjacent rooms of differing
full understanding of the correct gowning
classification (with doors closed). When
procedures for your cleanroom operation.
doors are open, outward airflow should be
sufficient to minimize ingress of Because gowning is integral to a facility’s
contamination, and it is critical that the operation and reflects many of the
time a door can remain ajar be strictly fundamental aspects of cGMPs, an initial
controlled.[13][14] evaluation of a facility can be conducted
by analysing where and how gowning
In some cases, the aseptic processing room
occurs. The following are three major
and adjacent cleanrooms have the same
gowning characteristics to look for.[3][17]
classification. Maintaining a pressure
differential (with doors closed) between 4.1. Centralized vs. decentralized
the aseptic processing room and these
adjacent rooms can provide beneficial Is gowning centralized or decentralized?
separation. In any facility designed with an Centralized gowning, occurring as part of
unclassified room adjacent to the aseptic the entry to a specific production area,
processing room, a substantial although not a guarantee, is indicative of
overpressure (e.g., at least 12.5 Pa) from organized and orderly production zones.
the aseptic processing room should be For centralization, functions of the same
maintained at all times to prevent cleanliness grade must be grouped
contamination. If this pressure differential together and not dispersed into
drops below the minimum limit, it is individualized or isolated islands of
important that the environmental quality of production. Centralized gowning is also
the aseptic processing room be restored indicative of organized material and
and confirmed.[3] personnel flows. If activities of one
hygiene type are aggregated together,
materials and personnel only need enter
4. Aseptic gowning the zone once to have access to all the
Aseptic gowning is essentially the process
functions within. This can be contrasted
of wearing clothing and garments to
with decentralized zones that require
control particulate contamination. These
material and personnel to enter and exit
layers of specially designed cleanroom
production areas multiple times in the
garments, cleanroom gloves, cleanroom
course of processing a single batch.
masks, and covers, help to minimize the
Operational time is wasted on excessive
amount of particulate that enters the
material handling and multiple
cleanroom environment. The
gowning/de-gowning sequences.[11][18]
specialized cleanroom garments isolate
your body from the clean room 4.2. Appropriate gowning
environment, ensuring that the particles
Is the protective clothing appropriate for •The risk of mix-up and cross
the cleanliness level of the area? In contamination is heightened.
production areas designed to be classified •There is an excessive amount of standard
as controlled environments (i.e., designed operating procedures.
using ISO 14644-1 or Annex 1 of the EU •Air-handling units are not efficiently
GMPs [Manufacture of Sterile Medicinal designed or operated.[21]
Products]), the greatest source of
contamination is the people working in the Although efficient air-handling units are
not strictly a GMP issue, like all the other
space. The clothing requirements must
issues enumerated, these operational
provide the amount of protection
inefficiencies are reflected in a higher than
commensurate to the type of product necessary cost of goods. In air handling,
processed, the operation being undertaken, for example, an economy of scale, duct
and the cleanliness class or grade of the layout, and energy usage is realized when
space in some facilities, for example, functions of a single cleanliness zone are
where primary and secondary packaging clustered together.[22]
are combined and have only a single
gowning access. Consequently, secondary
packaging must be maintained at the same
high level of cleanliness that is required
for primary packaging. In these facilities,
5. Gowning rooms
Gowning room are special airlocks for
the flow of materials for both primary and
the entry and exit of personnel to and
secondary share the same routing and
from a cleanroom. They should
result in intermixing of raw and in-process
include sufficient space for their
materials as well as primary and secondary
function, and, depending on the
packaging components. In this example,
cleanroom quality, facilities for
the easily identified misapplication of
donning and removing specialized
gowning reveals a larger GMP issue of
garments, and may include washing,
confused and disorganized material
disinfection facilities, etc. Special
handling. In addition, always gowning to
control devices such as air showers
the higher level increases operating costs
and shoe cleaners may be provided at
in terms of gowning materials used and
the point (s) of entry and exit the
operational time.[19][20]
cleanroom.[20][23]
4.3. Gowning inconsistency
Separation of personnel entering from
those leaving the cleanroom via the
There are older facilities where the
gowning room should be ensured. This
delineation between production and
controlled non-classified areas is not can be achieved by separation in time,
strictly drawn. If gowned and un-gowned or by providing physically separate
personnel are walking past each other in entry and exit routes. Where
the same hallway, this is a significant hazardous materials are processed, a
problem. Problems that can be surmised separate degowning and
about such a facility include: decontamination route should be
•Gowning is not centralized and time is considered.
wasted entering and exiting production
suites. To provide the requirement protection,
•Functional areas and hygiene zones are consideration should be given to three
not organized for greatest operational functional zones of the changing room
effectiveness.
•Flows are not unidirectional, resulting in At the changing room entry: access
raw and in-process materials routinely from ancillary areas (either directly or
crossing paths. via an airlock) appropriate for
removal, storage, disposal and/or ¡ Prominent display or posting of
redonning of garments not permitted gowning sequence, with clear
within the cleanroom; instructions; Full length mirrors to
check effective fit.[9][25]
The transition zone: area where
garments or personal equipment 5.1. General choice of cleanroom
dedicated to the cleanroom is stored, gowning
donned or removed, as appropriate.
The best design of cleanroom clothing
The inspection/access zone: area will completely envelop the person
where inspection of the completed and have good closures at the wrist,
gowning process is accomplished and neck and ankle. The choice will
which provides access to the depend on the class of cleanroom but
cleanroom either directly or via an cleanrooms with higher cleanliness
airlock. requirements are typified by a one-
piece coverall, overboots and a hood
The three functional zone may be
with yoke or skirt that tucks under the
separated by physical barrier (e.g.
neck of the garment. [8] Increasing
stepover bench or airlock) as
technical requirements on cleanroom
appropriate to the operation and use of
clothing may result in increasing
the changing room. The three zone
personal restrictions or discomfort.
should be established such that the
Therefore, consideration should be
zone closest to the cleanroom provides
given to what is necessary for the
a high degree of assurance, and that
standard of room cleanliness. Where
there will be minimal adverse impact
cleanliness and process requirements
caused by access or gowning
permit, clothing of lesser coverage
procedures implemented in the
may be acceptable. Certain separate
adjacent zone.[24]
devices with built-in clean air systems
The following requirements should be (e.g. minienvironments or isolators)
defined : Numbers of people passing may allow for the simplification of
through the gowning procedure, both required cleanroom clothing.[26][27]
in absolute, and at any on time; The
5.2. Classification of gowning
gowning procedure (i.e. what
required for clean areas
garments are to be taken off and put
on, whether there are reusable or  Grade D: Hair and, where
single-use , the required protocol to relevant, beard and moustache
ensure garment cleanliness and to should be covered. A
avoid crosscontamination. The general protective suit and
frequency of garment replacement. appropriate shoes or overshoes
should be worn. Appropriate
Consideration should be given to the
measures should be taken to avoid
following provisions in the changing
any contamination coming from
room :
outside the clean area.
Storage and disposal of garment;  Grade C: Hair and where relevant
Storage before use, provision and beard and moustache should be
disposal of consumable items and covered. A single or two-piece
accessories (e.g. gloves, masks, trouser suit, gathered at the wrists
protective glasses, overshoes); and with high neck and
Storage of personal items; Hand appropriate shoes or overshoes
washing and drying or other should be worn. They should shed
decontamination processes;
 virtually no fibres or particulate movement of all personnel should be
matter. applied. In general, personnel (or any
 Grade A/B: Sterile headgear other person) should not pass directly
should totally enclose hair and, from areas where there is exposure to
where relevant, beard and live microorganisms, GMOs, toxins or
moustache; it should be tucked animals to areas where other products,
into the neck of the suit; a sterile inactivated products or different
face mask and sterile eye organisms are handled. If such passage
coverings7 should be worn to is unavoidable, appropriate control
prevent the shedding of droplets measures (having regard to the risks)
and particles. Appropriate should be applied. When a person
sterilised, non-powdered rubber or moves from one clean room to another
plastic gloves and sterilised or clean room (higher to lower grade, or
disinfected footwear should be lower to higher grade) appropriate
worn. Trouser-legs should be disinfection measures should be
tucked inside the footwear and applied. The garment requirements
garment sleeves into the gloves. required for the relevant grade should
The protective clothing should be respected. Activities in clean areas,
shed virtually no fibres or especially when aseptic operations are
particulate matter and retain in progress, should be kept to a
particles shed by the body.[26] minimum. Excessive shedding of
[28] particles and organisms due to over-
vigorous activity should be avoided.
Outdoor clothing should not be Only the minimum number of
brought into changing rooms leading personnel should be present in clean
to grade B and C rooms. For every areas. Inspections and controls should
worker in a grade A/B area, clean be conducted outside the clean areas
(sterilised) protective garments as far as possible. Health monitoring
(including face masks and eye of staff should be proportional to the
coverings7 ) should be provided every risks. Where necessary having regard
time there is an entry into the clean to the specific risks of the product,
area; the need to exit and re-enter the personnel engaged in production,
clean area for a different maintenance, testing and internal
manufacturing step/different batch controls, and animal care should be
should be determined by the risk of vaccinated. Other measures may need
the activity. Gloves should be to be put in place to protect the
regularly disinfected during personnel according to the known
operations. Upon exit from a clean risks of the product and of the
area there should be a visual check of materials used in the manufacture
the integrity of the garment. Clean thereof.
area clothing should be cleaned and
handled in such a way that it does not In order to reach the B, C and D air
gather additional contaminants which grades the number of air changes
can later be shed. When working in a should be appropriate for the size of
contained area, protective clothing the room and the equipment and
should be discarded before leaving the personnel present in it.
contained area. Wristwatches, make-
High-efficiency particulate air
up and jewellery should not be worn
(HEPA) filters should be subjected to
in clean areas. Where required to
an installed filter leakage test in
minimise the risk for cross-
accordance with ISO 14644-3 at a
contamination, restrictions on the
recommended interval of every 6
 months, but not exceeding 12 months. been put on, gloves, facemasks and
The purpose of performing regular goggles are put on. Importantly, there
leak tests is to ensure the filter media should be no exposed skin.
filter frame and filter seal are free
Single-use disposable garments are made
from leaks. The aerosol selected for
from two types of fabric: 1) Flash-spun
HEPA leak testing should not support
polyethylene fabric, which provides
microbial growth and should be
filtration efficiency for submicron sized
composed of a sufficient number or
particles and microorganisms, is suitable
mass of particles. HEPA filter
for light splash protection from non-
patching is allowed at the filter
hazardous liquids.) Spunbond meltblown
manufacturer and in situ operation
spunbond (SMS) fabric, which has outer
provided that the patch sizes and
layers of spunbond polypropylene for
procedures follow the
strength and cloth-like comfort, and
recommendations of ISO 1822-4.[29]
middle layers composed of a matrix of
5.3. Cleanroom gowns microfibers, which creates a strong barrier
for fine particles and liquids. The three
Gowns can be ‘reusable’ or single-issue.
SMS layers have a mazelike quality that
Reusable gowns are subject to washing traps particles, while maximizing airflow
(re-laundered), followed by packing and
to keep the operator cool and comfortable.
irradiation. Reusable cleanroom fabrics are
manufactured using 100% continuous Laundered reusable garments typically
filament polyester and continuous filament contain a single layer of woven
polyester/carbon combination yarns to polyesterblend fabric, which, coupled with
minimise particle shedding. Non-woven the weave, may allow particles to pass
fabrics are constructed of a polyolefin through. The fabric also may degrade after
fibre and used in disposable cleanroom multiple laundering and sterilization
garments. All cleanroom gowns are cycles, compromising the barrier built into
designed to act as filters, allowing air to the garment material. Kimberly-Clark
pass through but to retain microorganisms. Professional; conducted testing on
There is little difference between re- laundered reusable garments and found
laundered and disposable gowns – the that the Bacterial Filtration Efficiency
choice comes down to operator preference (BFE) declines more than 25% after an
or company economics. average of five washings. That is like 1 out
of 4 workers not wearing sterile garments
While the difference between gown types at all. This presents a real, yet invisible,
may not overly matter, there are a number
contamination risk to cleanroom
of factors to consider when selecting a environments.
suitable gown. These include thickness,
weight, flexibility, filtering properties, List of gowns: Primary Change (Non
durability and comfort. Assessing these Classified/Grade D) Area Gown Inner,
requires a review by the cleanroom Jacket, Trouser, Cap, Facemask, Beard
manager supported by the microbiologist. cover, dedicated shoe, socks. Grade C
Gowns worn in aseptic processing areas Area Gown – sanitized Coverall, Hood
need to be sterile and they should only be with facemask, Booties, Hand gloves.
worn for one session before being sent for Grade B Area Gown – sterilized Coverall,
re-laundering or disposal. Further to Hood with facemask, Booties, hand
aseptic processing, cleanroom gowns are gloves. [15][18]
not worn over street clothes; instead,
5.4. Cleanroom gowning procedures
operators strip down to their
in general
undergarments and don a polyester under-
suit. Once the under and outer gown have
 Cleanroom personnel will change into 9) Select cleanroom clothing.
cleanroom clothing before proceeding
10) If required, put on gloves for
into a cleanroom. A method should be
handling cleanroom clothing.
adopted to put on and remove clothing
to minimize contamination of the 11) Put on face and head covering.
outside of the cleanroom clothing and
to ensure contamination is not spread 12) Put on coverall or gown.
from the changing area. Several 13) Put on shoe coverings or special
methods are acceptable depending on cleanroom shoes, using a crossover
the design of the changing area and bench.
the standard of cleanliness of the
cleanroom. Usually the process begins 14) Using a full-length mirror, ensure
at the head and proceeds downward to that all items of clothing are properly
the feet. adjusted.

The following list of steps outlines one 15) Gloves used for putting on
typical procedure that is commonly cleanroom clothing can now either be
used, but many variations exist to removed, or left on, so that process
comply with contamination control gloves can be put on.
needs for certain types of cleanrooms.
16) Enter the cleanroom.The way
1) Remove contamination from shoes cleanroom clothing should be taken
by use of a shoe cleaner, cleanroom off when leaving the cleanroom will
mat or cleanroom flooring. depend on whether fresh clothing is
used on each entry or whether the
2) Remove unnecessary street clothing is to be reused. Methods for
clothing. removing cleanroom clothing that will
3) Remove jewellery, etc. if required. be reused are described in other
sources. Special storage methods can
4) Remove cosmetics and put on be used if the clothing is to be reused
moisturizer, if required. and are dn`1escribed in other sources.
Cleanroom clothing should not be
5) Put on hair cover, if applicable.
removed from the controlled
6) Wash hands and put on suitable environment except for transfer to the
moisturizer, if applicable. laundry for cleaning.[21]
7) Put on cleanroom underclothing, if
applicable.
8) Put on cleanroom-dedicated under-
shoes, or shoe covers.

Room grade garment Illustration example

CNC/D/C/B (layer 1 Socks, long underpants,
underwear for all areas) sweatshirt/t-shirt
 CNC (layer 2) Socks, long underpants,
CNC-overcoat, safety
shoes, CNC hair
net(optional for CNC)

D (layer 2) Socks, long underpants,

sweatshirt/t-shirt, grade-
D-overcoat, grade-D-
trousers, safety shoes,
grade D gloves, Hair
net/cover, face
mask(optional) and beard
cover.

C (layer 2) Socks, long underpants,

sweatshirt/t-shirt, grade C
one place jumpsuit, safety
shoes, grade C gloves,
hair net cover, face mask
and beard cover.

B (layer 2) Socks, long underpants,

sweatshirt/t-shirt, safety
shoes grade B, full body
protective overall for
grade B, gloves, head
cover, safety goggles,
face mask.

Table 2. Gowning concept

Personal air lock (PAL) No. grade Gowning procedure

1 C Entering grade B: taking of
layer 2 for grade D
Leaving grade B:
- Putting on layer 2
for grade D
- Verification of
clothing in the
mirror.
 2 B - Putting on layer 2
for grade B out of
pass- through locks.
- Verification of
clothing in the
mirror.
- Glove disinfection
3 B Walk through in to grade B
corridor.
4 B Walk through in to grade B
PAL out leaving grade B
corridor.
5 B Taking off layer 2 for grade
B and put in pass-through
locks.
Table 3. Example from grade D to grade B and backwards.

5.5. Gowning procedure for clean » Wear cream colored jacket and then
areas cream colored trouser. Tuck the shirt in
the trouser.
For Change Room (Non Classified Area):
» Put on socks and shoe dedicated for this
 – Wash hands with liquid soap and dry
area. 
with hand dryer at the entrance of change
room. Gowning Procedure for Primary Change
Room (Packaging Area / Grade D Area):
– Sitting on the step over bench outside
shoes shall be removed and shoes – At the primary change area, leave the
dedicated for gray side of step over bench shoes and keep in the box of gray side of
shall be put on. the step over bench. Sit on the step over
bench and cross it swinging legs over the
– The outside shoe shall be kept in the
bench.
locker at the change area.
– Put on shoe dedicated for this area.
– The outside clothes shall be removed,
kept in locker. – Inspect yourself in the mirror for proper
gowning.
– Half sleeves T-shirt shall be put on.
– After the gowning requirements have
– Then the shoe dedicated for gray side of
been met, personnel can enter the grade D
step over bench shall be kept in the gray
area.
side box of the step over bench before
crossing it. Gowning Procedure for Primary Change
Room (Process Area / Grade C Area):
– Sitting on the step over bench it shall be
crossed swinging the leg over the bench. - Sitting on the step over bench remove
the shoe and keep in the box at the gray
– Shoes dedicated for white side of step
side of the step over bench.
over bench shall be put on.
- Swing the leg over the step over bench,
– Then attire shall be put on in the
cross it and put on the dedicated shoe kept
following sequence:
in the box at the white side of the bench.
» Put on the cream colored cap to
- Disinfect hands with 70% IPA and enter
completely cover hair and ear.
into the Secondary Change Room 1.
 - Then enter into the Secondary Change • Enter into the Sterile Change Room
Room. through the air lock.
Gowning Procedure For Secondary  Gowning Procedure for Sterile Change
Change Room (Process Area / Grade C Room (Filling Area / Grade B Area):
Area):
• Wear cleaned & sterilized hood.
- Disinfect hands with 70% IPA solution.
• Then put on cleaned, sterilized protective
- Wear cleaned & sanitized hood.
cover all avoiding any touch on the floor.
- Now put on cleaned, sanitized protective The hood should be tucked inside the neck
coverall avoiding any touch on the floor. of the coverall.
The headgear should be tucked inside the
• Wear sterilized arm cover (Only for
neck of the uniform.
filling operators).
- Sit on the step over bench, put on
• Sit on the step over bench, put on
sanitized protective booties one by one
sanitized protective booties one by one
avoiding any touch on the floor of gray
avoiding any touch on the floor. The
side of the step over bench. The bootie
booties shall be put on over the shoes
shall be put on over the shoes totally
totally enclosing the feet and the bottom of
enclosing the feet and the bottom of
coverall tucked inside the booties.
coverall tucked inside the booties.
• Cross the step over bench, swing the legs
 - Cross the step over bench swinging the
one by one over it.
legs one by one over it.
• Put off the previous hand gloves and
- Disinfect hands with 70% IPA solution.
disinfect hands with 70% IPA.
- Put on the hand gloves and disinfect
• Put on another fresh hand gloves and
hands with 70% IPA again. - inspect
disinfect hands with 70% IPA again.
yourself in the mirror and enter into grade
C area. [22] • Ensure that the hand gloves cover the
wrist of the protective coverall/arm cover. 
 Gowning Procedure For Primary Change
Room (Filling Area / Grade B Area): • Inspect yourself in the mirror.
• Remove the cream colored jacket, • After all the requirements have been
trouser and cap and keep in the locker at met, personnel can enter the grade B Area.
the primary change room.
After proper and complete gowning:
• Sitting on the step over bench remove the
shoe and keep in the box at the gray side  - Replace any cleanroom attire that is
of the step over bench. worn or soiled.

• Swing the leg over the step over bench - When leave the area always keep the
cross it and put on the shoe kept in the box gowns in the specific bin.[24]
at the white side of the bench. 5.6. Key garmenting guidelines:
• Disinfect hands with 70% IPA. Don't Touch! Most cleanliness violations
• Wear the white colored cap, shirt and the occur when a garment is touched by dirty
trouser avoiding any touch on the floor. hands, or when it touches a dirty floor.
Tuck the shirt inside the trouser. Wear Hands and gloves should therefore be
white facemask and hand gloves. washed and dried frequently. Dress from
the Head Down! That way, released
particles will not fall on clean garments or
booties. Understand Garment Design! In environment, and isolate your body from
most instances, gloves and booties are the clean room environment, ensuring that
worn over coverall sleeves and cuffs, and the particles emitted from the body do not
hoods are tucked inside collars. Make sure contaminate the environment. Here was
that personnel are trained on how to seal also described proper gowning procedures
these gaps between clothing, and include a as the staff is also main component of
mirror to allow final selfinspection. Hang cleanroom environment. People should be
a photo of a correctly garbed person next trained and well qualified to work and
to the mirror as a "howto" guide. Minimize maintain in the cleanroom.
Motion! walking from one change room
location to another, release millions of 7. References
particles. Change room plans should [1] G. A. Chaudhari and S. H.
therefore minimize motion, especially Sarje, “Clean Room
during the final stages of dressing, by Classification for
efficiently organizing the flow of Pharmaceutical Industry,” no.
personnel from one station to another. 4, pp. 241–244, 2015.
Train and Reinforce! A good change room
[2] “INTERNATIONAL STANDARD,”
design supports proper protocol, but it
vol. 2015, 2016.
does not teach it. Make sure that personnel
complete a formal training program, and [3] D. History, “ANNEX 1
stress protocol by hanging reminder MANUFACTURE OF STERILE
posters at every gowning station that MEDICINAL PRODUCTS,” vol.
reinforce proper procedures. Minimize 2008, no. November, pp. 1–16,
Maintenance! Do you have dedicated, 2008.
trained personnel to peel off adhesive shoe [4] P. Angtrakool, “International
mats, wipe down gowning benches, keep Standard International
"clean zones" regularly scrubbed, empty Standard : ISO 14644.”
waste receptacles, restock garb dispensers,
and perform other upkeep with the [5] M. Kitain and B. Services,
absolute regularity that your protocol “Mikhail Kitain CLEANROOMS IN
PHARMACEUTICAL
requires? If not, look for ways to minimize
PRODUCTION,” no. March,
reliance on humans through automation,
2010.
careful product positioning, choice of
materials, and so forth. [9][8] [6] P. Angtrakool, “Cleanroom For
Sterile Manufacturing
Facilities.”
6. Conclusion
The pharmaceutical production must [7] I. J. Pharm and P. Res,
effectively control the contamination from “International Regulatory
people, raw materials, finished products as Agencies,” vol. 1, no. 4, pp.
well as accommodating-services, process 208–214, 2012.
plant and equipment. The main purpose of [8] S. Edition, CRITICAL Handbook
aseptic gowning is to provide a vital for CRITICAL Handbook for. .
element in the assurance of production
process sterility according to whole [9] “fdc31580c209b98addbaa63bfa
concept of good pharmaceutical 140ddd.pdf.” .
manufacturing operation. The choice of [10] E. Gottlieb, “Understanding ISO
gowns and gowning procedure for clean 14644- 1 / 2 : 2015 and
rooms should prevent contamination of the Becoming Compliant,” pp. 1–
product, minimize the amount of 33, 2015.
particulate that enters the cleanroom
[11] S. D. Products, C. Good, and M.
 Practice, “Sterile Drug Products Sterile Cleanroom Gowning
Current Good Manufacturing Evolves to Help Minimize
Practice Guidance for Contamination Risk.”
Industry,” no. September,
2004. [22] T. Sandle, “People in
Cleanrooms : Understanding
[12] “Pharmaceutical Microbiology and Monitoring the Personnel
Manual,” pp. 3–30, 2015. Factor Peer Reviewed :
Cleanroom Contamination,”
[13] S. Behme, Production of 2014.
Recombinant Proteins Biotech
Funding Trends. . [23] for Pharmacy Technicians. .
[14] R. L. Friedman, “Aseptic [24] W. H. O. Prequal, “Annex 6
Processing Contamination Case WHO good manufacturing
Studies and the Pharmaceutical practices for sterile
Quality System.” pharmaceutical products WHO
good manufacturing practices,”
[15] “Aseptic Processing Practices no. 961, pp. 261–284, 2011.
and Process Validation of
Aseptic Operators.” [25] A. R. E. Reusable, “AT RISK ?”
[16] M. Practice, “Guidance for [26] I. Pharmacopoeia,
Industry,” no. August, 2003. “SPECIFICATIONS FOR
PHARMACEUTICAL
[17] D. History, “European PREPARATIONS Thirty-ninth
commission,” vol. 4, no. report.”
November 2017, 2018.
[27] S. Drug and P. Inspections,
[18] B. Ljungqvist, “Aseptic “Food and drug
Production, Gowning Systems, administration,” 2016.
and Airborne Contaminants,”
pp. 30–33, 2005. [28] E. Alici and P. Blomberg, “GMP
Facilities for Manufacturing of
[19] G. Area and S. C. Protocol, Advanced Therapy Medicinal
“Cleanroom Recommended Prod- ucts for Clinical Trials :
Gowning Protocol,” pp. 3–5, An Overview for Clinical
2015. Researchers,” pp. 508–515,
[20] S. Covers, G. Gloves, B. Covers, 2010.
and B. Covers, “Non-Sterile [29] I. Standard, “INTERNATIONAL
Cleanroom Gowning Procedure STANDARD,” vol. 2004, 2004.
Non-Sterile Cleanroom Gowning
Removal Procedure,” pp. 1–2,
2016.
[21] D. Larkin, “Donning by Design :