Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning procedures are important because contamination can be invisible. Operators must be well-trained in gowning to avoid introducing contamination. Gowning includes showering and hygiene at home, changing at work while avoiding contact with floors, and wearing multiple layered garments specific to each cleanroom grade that fully cover the body and shed no particles. Proper gowning allows entry to production areas while avoiding contamination.
2. Gowning
What is Gowning
• Gowning: The process of wearing special
garments in order to control particulate
contamination.
3. Gowning
Importance of Gowning
Correct gowning procedures are also of paramount
importance. One of the problems with particulate
contamination is that it is largely invisible to the naked
eye. Any contamination introduced into the cleanroom
on the outer surface of clothing will go unnoticed and
so any breakdown in correct gowning procedures will
not be immediately apparent. Thus it is vital that
operators are well versed and well practiced in correct
gowning procedures. It can be very helpful if a system
of mutual help is in place. That is, the operators
observe each other and, in a non-threatening way
point out faults that may occur.
4. Gowning
Special Instruction
• Access to production area shall be permitted only
through the personnel entry wearing proper gowning.
• This attire shall not be worn outside the change area.
• Personnel shall be restricted from:
Wearing nail polish or false fingernails.
Wearing Jewelry, wrist watch, etc.
Cosmetics, hair spray, perfumes
Carrying mobile.
• Personnel in clean area shall wear clean area attire at
all times during production hours.
5. Gowning
At Home Preparation
At Home Preparation
• Shower
• Shave
• Brush teeth
• Brush hair
• Proper attire
• Skin Moisturizers
• Practice good personal hygiene
• Select non shedding undergarment
• Select non shedding over garments
6. Gowning
Pre-gowning at Work
• Report any medical conditions to supervisor
• Store all outer garments and personal belongings
separately and secure
• Remove all non-approved jewelry & store
• Remove all cosmetics
• Wash & dry hands
• Put on factory gowns, shoes/shoe covers
7. Gowning
Cleanroom
• Know what class of cleanroom you're
entering.
GMP EU classification maximum particles/m³
under under
under working under working
Class equipped equipped
conditions conditions
conditions conditions
0.5 µm 5 µm 0.5 µm 5 µm
Class A 3,500 0 3,500 0
Class B 3,500 0 350,000 2,000
Class C 350,000 2,000 3,500,000 20,000
Class D 3,500,000 20,000 n/a n/a
8. Gowning
Change Room
Change room: A well thought-
out and planned change room is
critical to the smooth operation of
a cleanroom. A good change
room design will speed the entry
and exit of personnel using The
cleanroom while at the same
time providing all of the
necessary features and support
which are critical to a properly
operating cleanroom facility.
9. Gowning
Personnel Routes
• Personnel routes are strictly maintained
• Primary change room (Non classified)
Grade D support room Grade D Area
• Primary change room (Non classified)
Secondary change room (Grade D) Grade C
support room Grade C Area
• Primary change room (Grade D) Secondary
change room (Grade C) Grade B support
room Grade B Area
10. Gowning
List of Gowns
• Primary Change (Non Classified/Grade D) Area Gown
– Inner, Jacket, Trouser, Cap, Face mask, Beard
cover, Dedicated shoe, socks
• Grade C Area Gown – sanitized Coverall, Hood with
face mask, Booties, Handgloves
• Grade B Area Gown – sterilized Coverall, Hood with
face mask, Booties, Handgloves
Note: Clean area gown shall be lint free and non
shedding.
13. Gowning
Procedure
For Change Room (Non Classified Area)
– Wash hands with liquid soap and dry with hand
dryer at the entrance of change room.
– Sitting on the step over bench outside shoes shall
be removed and shoes dedicated for gray side of
step over bench shall be put on.
– The outside shoe shall be kept in the locker at the
change area.
– The outside clothes shall be removed, kept in
locker.
– Half sleeves T-shirt shall be put on.
– Then the shoe dedicated for gray side of step over
bench shall be kept in the gray side box of the step
over bench before crossing it.
14. Gowning
Procedure
– Sitting on the step over bench it shall be
crossed swinging the leg over the bench.
– Shoes dedicated for white side of step over
bench shall be put on.
– Then attire shall be put on in the following
sequence:
» Put on the cream colored cap to completely
cover hair and ear.
» Wear cream colored jacket and then cream
colored trouser. Tuck the shirt in the trouser.
» Put on socks and shoe dedicated for this
area.
15. Gowning
Procedure
For Primary Change Room (Packaging Area /
Grade D Area)
– At the primary change area, leave the shoes
and keep in the box of gray side of the step
over bench. Sit on the step over bench and
cross it swinging legs over the bench.
– Put on shoe dedicated for this area.
– Inspect yourself in the mirror for proper
gowning.
– After the gowning requirements have been
met, personnel can enter the grade D area.
16. Gowning
Procedure
For Primary Change Room (Process Area / Grade
C Area)
- Sitting on the step over bench remove the shoe
and keep in the box at the gray side of the step over
bench.
- Swing the leg over the step over bench, cross it
and put on the dedicated shoe kept in the box at the
white side of the bench.
- Disinfect hands with 70% IPA and enter into the
Secondary Change Room 1.
- Then enter into the Secondary Change Room.
17. Gowning
Procedure
For Secondary Change Room (Process Area /
Grade C Area)
- Disinfect hands with 70% IPA solution.
- Wear cleaned & sanitized hood.
- Now put on cleaned, sanitized protective coverall
avoiding any touch on the floor. The headgear should
be tucked inside the neck of the uniform.
- Sit on the step over bench, put on sanitized
protective booties one by one avoiding any touch on
the floor of gray side of the step over bench. The
bootie shall be put on over the shoes totally enclosing
the feet and the bottom of coverall tucked inside the
booties.
18. Gowning
Procedure
- Cross the step over bench swinging the legs one
by one over it.
- Disinfect hands with 70% IPA solution.
- Put on the hand gloves and disinfect hands with
70% IPA again.
- inspect yourself
in the mirror and enter
into grade C area.
19. Gowning
Procedure
For Primary Change Room (Filling Area / Grade B
Area)
• Remove the cream colored jacket, trouser and cap
and keep in the locker at the primary change room.
• Sitting on the step over bench remove the shoe
and keep in the box at the gray side of the step over
bench.
• Swing the leg over the step over bench cross it
and put on the shoe kept in the box at the white side of
the bench.
• Disinfect hands with 70% IPA.
• Wear the white colored cap, shirt and the trouser
avoiding any touch on the floor. Tuck the shirt inside
the trouser. Wear white facemask and hand gloves.
• Enter into the Sterile Change Room through the
20. Gowning
Procedure
For Sterile Change Room (Filling Area / Grade B
Area)
• Wear cleaned & sterilized hood.
• Then put on cleaned, sterilized protective coverall
avoiding any touch on the floor. The hood should be
tucked inside the neck of the coverall.
• Wear sterilized arm cover (Only for filling
operators).
• Sit on the step over bench, put on sanitized
protective booties one by one avoiding any touch on
the floor. The booties shall be put on over the shoes
totally enclosing the feet and the bottom of coverall
tucked inside the booties.
21. Gowning
Procedure
• Cross the step over bench, swing the legs one by one
over it.
• Put off the previous hand gloves and disinfect
hands with 70% IPA.
• Put on another fresh hand gloves and disinfect
hands with 70% IPA again.
• Ensure that the hand gloves cover the wrist of the
protective coverall/arm cover.
22. Gowning
Procedure
• Inspect yourself in the mirror
• After all the requirements
have been met, personnel can
enter the grade B Area.