Gowning

2. Basic cGMPs
• Remember, QUALITY
is the responsibility of
everyone
• Don’t just make the
product or do your job
and leave it up to
Quality Assurance fix
the problems

3. The Regulations
• cGMP stands for
“current Good
Manufacturing
Practices”
• Always improving and
changing (that is why
they are called “current”)
• Regulations are a
minimum that must be
met

4. The Regulations
• cGMPs are listed in
the CFR (Code of
Federal
Regulations) Part
210 and 211
• Part 210 - definitions
• Part 211 - basic
instructions
• Part 11 - electronic
data

5. Organization and Personnel
• Shall have a Quality Unit
with responsibility to
reject or approve all
material, procedures and
specifications
• Everyone will have
sufficient training,
knowledge and
experience to do their
job

6. Organization and Personnel
• Wear clean clothing
• Wear protective apparel to
prevent contamination
• Practice good sanitation
• If you are sick or have
open lesions that would
impact the drug, then you
will be excluded from
direct contact with the
product

7. Buildings and Facilities
• Building will be
adequately sized for
proper storage of
equipment and
material
• Operations will be
performed in
specific areas

8. Buildings and Facilities
• Raw materials received will be
placed in quarantine until
tested
• Rejected material will be
separated
• There will be adequate
lighting
• There will be adequate
environmental controls
• There will be air breaks on

9. Buildings and Facilities
• Sewage and trash
will be stored and
disposed of in a safe
and sanitary manner
• Adequate washing
and toilet facilities
will be available
– hot and cold water
– soap
– single service towels

10. Buildings and Facilities
• Building will be
maintained in a clean
and sanitary manner
• There will be cleaning
schedules with
approved cleaning
agents
– SOPs on cleaning
• Buildings in a good
state of repair

11. Buildings and Facilities
• Buildings
maintained pest and
rodent free
• Written procedures
and approved
rodentcides,
insecticides and
fungicides
– will not affect product

12. Equipment
• Will be maintained in a
good state of repair
– written schedule of
maintenance
• will be cleaned
– written schedule of
cleaning
– clean after each batch
• approved cleaning agents
– will not affect product
• ID number on equipment

13. Control of Raw Materials
• Received in Quarantine
– not used until released
• Written procedures on receipt,
handling and sampling
• Stored off the floor
• Each container marked with lot
number, name and status
(released, quarantined,
rejected)

14. Control of Raw Materials
• Sampling
– shall be representative
– maintain cleanliness
– in approved area
– prevent cross
contamination
– containers marked showing
samples taken

15. Production and Process
Control
• There will be written
procedures
• Document activities
– batch record
– log books
• Control contamination
• Cleanliness
– tanks, paddles, piping, probes,
etc.
• Keep organized

16. Production and Process
Control
• Reconciliation to be
done
• Make sure areas are
cleared of other lot
information
(packaging, labeling,
etc.) prior to working
with another lot
• Double checks

17. Warehouse
• It shall be clean
• Sections clearly identified
(quarantine, released,
rejected)
• quarantine - yellow
• released - green
• rejected - red
• First In - First Out
• Track inventory and sold
lots (quantities to where)

18. Laboratory
• Will have specifications,
standards, sampling plans, test
procedures
• Shall have a calibration and
maintenance program
– written with a time period for
performance
• Document all testing
– use logbooks

19. Laboratory
• Tell supervisor if something goes
wrong
– don’t continue with testing if done
improperly
– check results prior to discarding sample
• have second person check
• check acceptance values
• Stability testing will be done
• Reserve samples will be kept for final
products over the period of the
expiration date

20. Documentation
• Records will be maintained
• batch records
• testing
• investigations
• training
• maintenance
• cleaning
• almost everything
• If it was not documented, then it
did not happen!
• Written in ink

21. Documentation
• Cross out with single line;
initial and date
• No white-out
• Don’t use scrap paper
• Change control on all
documents
• if changes are made, they have to
be reviewed
• Sign only what you performed
or verified

22. GOWNING

23. Gowning
What is Gowning
• Gowning: The process of wearing special
garments in order to control particulate
contamination.

24. 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.

25. 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.

26. 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

27. 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

28. Gowning
Cleanroom
• Know what class of cleanroom you're
entering.
GMP EU classification
Class
maximum particles/m³
under
equipped
conditions
under
equipped
conditions
under working
conditions
under working
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

29. 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.

30. 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

31. 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.

32. Gowning
Cleanroom Gown
Grade C
Area Gown
Grade B
Area Gown

33. Gowning
Cleanroom Gown (Grade B)
Hood
Coverall
Booties
Face mask
Gloves

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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

41. 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.

42. 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.

43. Gowning
Procedure
• Inspect yourself in the mirror
• After all the requirements
have been met, personnel can
enter the grade B Area.

44. Gowning
Procedure
After proper and complete gowning:

45. Gowning
Procedure
- Replace any cleanroom attire that is worn or
soiled.
- When leave the area always keep the gowns in
the specific bin.

46. 46
Producing sterile drug products
Terminal sterilization
• Product containers are filled
and sealed under high-quality
environmental conditions
designed to minimize
contamination, but not to
guarantee sterility.
• Product in its final container
is subject to a sterilization
process such as heat or
irradiation.
Aseptic processing
• Drug product, container, and
closure are subject to
sterilization separately, and
then brought together.
• Because there is no process
to sterilize the product in its
final container, it is critical
that containers be filled and
sealed in an extremely high –
quality environment.

47. 47
Terminal Sterilization
Drug
Product
Container /
Closure
Excipients
Sterilization
Process
Sterile
Drug
Product !
Sterilization Process must be compatible with all components !

48. Aseptic Processing
48
Drug
Produc
t
Sterilization
Process
Container
Closur
e
Excipient
Sterilization
Process
Sterilization
Process
Sterilization
Process
Sterile
Closure
Sterile
Excipient
Aseptic
Processin
g
Sterile
Drug
Product
Sterile
Container
Sterile
Final
Product
Can use multiple sterilization processes each optimized for the individual component

49. What do the regulators expect?
49
“Sterile drug manufacturers should have a keen
awareness of the public health implications of distributing
a non sterile product. Poor CGMP conditions at a
manufacturing facility can ultimately pose a life-
threatening health risk to a patient.”
FDA Guidance “Sterile Drug Products Produced by Aseptic
Processing-Current Good Manufacturing Practice” 2004
“The manufacture of sterile products is subject to special
requirements in order to minimize risks of microbiological
contamination, and of particulate and pyrogen
contamination.”
EU GMP Annexe 1

50. Aseptic Practices to be followed while Working in the Clean Room
• Open doors slowly.
• Allow doors to get closed slowly as these are equipped with door
closers.
• Do not open two adjacent doors at a time.
• Avoid unnecessary talking, laughing etc. while working in the clean
room.
• No running, fast walking or silly behavior in the clean rooms.
• Do not touch the wall or doors inside the sterile area unless required.
• Do not touch work surfaces.
• Movements such as head scratching, rubbing hands or parts of the
body must be avoided.
• Do not lean over the product.
• Before and after carrying out any aseptic handling, disinfect the
hands by using IPA 70% .
• Disinfect tools which are used for machine adjustments or any
aseptic handling , before & after every use ( not applicable if used
through glove ports)
• Avoid touching goggles, mask or gown inside aseptic area.

51. A way of working which
minimises potential for
introducing microbiological
contamination during
aseptic processing
Good Aseptic Practice

52. Thank You