Uploaded byShoab Malek (Certified Quality Auditor)
Gowning procedure for Pharma Manufacturing Area
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning is important because particulate contamination is invisible. Operators must be trained in proper gowning procedures to prevent introducing contamination. Gowning involves several steps like showering, removing jewelry at home and at work, and putting on attire like coveralls, booties and gloves in the correct order when moving between areas of different cleanroom classes. Maintaining clean attire and routes is important for minimizing contamination risks.
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Gowning procedure for Pharma Manufacturing Area
- 1. GOWNING Shoab Malek Certified Auditor& Pharma Consultant shoab.malek@gmail.com +91 9638069084
- 2. Gowning What is Gowning •Gowning: The process of wearing special garments in order to control particulate contamination. shoab.malek@gmail.com +91 9638069084
- 3. Gowning Importance of Gowning Correctgowning 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. shoab.malek@gmail.com +91 9638069084
- 4. Gowning Special Instruction • Accessto 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. shoab.malek@gmail.com +91 9638069084
- 5. Gowning At Home Preparation AtHome Preparation • Shower • Shave • Brush teeth • Brush hair • Proper attire • Skin Moisturizers • Practice good personal hygiene • Select non shedding undergarment • Select non shedding over garments shoab.malek@gmail.com +91 9638069084
- 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 shoab.malek@gmail.com +91 9638069084
- 7. Gowning Cleanroom • Know whatclass 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 shoab.malek@gmail.com +91 9638069084
- 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. shoab.malek@gmail.com +91 9638069084
- 9. Gowning Personnel Routes • Personnelroutes 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 shoab.malek@gmail.com +91 9638069084
- 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. shoab.malek@gmail.com +91 9638069084
- 11. Gowning Cleanroom Gown Grade C AreaGown Grade B Area Gown shoab.malek@gmail.com +91 9638069084
- 12. Gowning Cleanroom Gown (GradeB) Hood Coverall Booties Face mask Gloves shoab.malek@gmail.com +91 9638069084
- 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. shoab.malek@gmail.com +91 9638069084
- 14. Gowning Procedure – Sitting onthe 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. shoab.malek@gmail.com +91 9638069084
- 15. Gowning Procedure For Primary ChangeRoom (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. shoab.malek@gmail.com +91 9638069084
- 16. Gowning Procedure For Primary ChangeRoom (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. shoab.malek@gmail.com +91 9638069084
- 17. Gowning Procedure For Secondary ChangeRoom (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. shoab.malek@gmail.com +91 9638069084
- 18. Gowning Procedure - Cross thestep 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. shoab.malek@gmail.com +91 9638069084
- 19. Gowning Procedure For Primary ChangeRoom (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 theshoab.malek@gmail.com +91 9638069084
- 20. Gowning Procedure For Sterile ChangeRoom (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. shoab.malek@gmail.com +91 9638069084
- 21. Gowning Procedure • Cross thestep 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. shoab.malek@gmail.com +91 9638069084
- 22. Gowning Procedure • Inspect yourselfin the mirror • After all the requirements have been met, personnel can enter the grade B Area. shoab.malek@gmail.com +91 9638069084
- 23. Gowning Procedure After proper andcomplete gowning: shoab.malek@gmail.com +91 9638069084
- 24. Gowning Procedure - Replace anycleanroom attire that is worn or soiled. - When leave the area always keep the gowns in the specific bin. shoab.malek@gmail.com +91 9638069084
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