Gowning in the pharmaceutical industry

GOWNING IN THE PHARMACEUTICAL INDUSTRY
PREPARED BY: JONY MALLIK
INDUSTRIAL PHARMACIST & COLUMN WRITER
Pharmaceutical Company is a specialized area that needs a regulated environment completely
different from our home or outside area for conducting overall manufacturing activities. It is
important for a pharmaceutical company to have procedures in place to prevent contamination
within the building and especially in the processing area. The procedure needs to cover the changing
of clothes during entry and exit of the designated changing areas. The following assumes there is a
first change room that all visitors to the site or factory will have to pass through. This provides
protection for staff entering the warehouse, dispensing, and sampling areas. A further change room
(the Primary Change Room) is necessary to prevent contamination of the more critical areas of the
facility, i.e., the manufacturing and packaging sections.
GOWNING: The process of wearing special garments in order to prepare oneself to enter into an
environment controlled area to avoid any possible particulate contamination.
SPECIAL INSTRUCTIONS:
Industrial personnel or visitors who have proper gowning will only get access to enter into the
production facility.
Personnel shall be restricted from wearing of nail polish or false fingernail, jewelry, wrist watch,
cosmetics, hair spray, perfumes and carrying mobile.
NOT ALLOWLED IN OSD/STERILE FACILITY

Gowning Requirements
UNITED STATES: FDA: CFR – Code of Federal Regulations Title 21
Sec.211.28 Personnel responsibilities: (a) Personnel engaged in the manufacture, processing,
packing, or holding of a drug product shall wear clean clothing appropriate for the duties they
perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary
to protect drug products from contamination.
Gowning Preparation at Home:
 Shower
 Shave
 Brush teeth
 Brush hair
 Proper attire
 Skin moisturizers
 Practice good personal hygiene
 Select non shedding undergarment
 Select non shedding over garments
Pre-Gowning at Work:
Report any medical conditions to supervisor.
Store all outer garments and personal accessories separately secured with lock.
Remove all non-approve jewelry and cosmetics.
*Photos of the garments should be displayed in the changing rooms.
First Change Rooms – Male and Female staff and visitors to the facility
 Cleaned and washed factory garments should be provided every Saturday and Thursday to
employees as required.
 Cleaned, and washed factory socks should be provided every day.
 Jewelry, street clothes and shoes should be placed in the staff’s locker room.
 Appropriate black/grey colored shoes should be provided and worn by staff working in the
facility.
 Disposable garments should be provided for guests or visitors.
 Shoe covers should be provided for visitors.
Primary Change Room – for male and female personnel (e.g., working in the sampling and dispensing
room in the warehouse)
 Cleaned, and washed primary change uniforms should be provided.
 A change of uniform is required for every product changeover.

Procedure on gowning for staff working manufacturing and primary packaging personnel
 After entering the primary change room, staff should remove their street shoes and place
them in the rack provided
 Wash hands with soap and dry hands with dryer.
 Move over to the changing bench.
 Take lint free trousers, caps and shirt from the hanger.
 Put on lint free shirt, trouser and caps over the previously donned uniform.
 Wear brown/grey/black colored shoes that are provided in the locker. (Shoe must cover the
foot)
 Note - shoe covers or brown shoes should be provided for visitors.
 Apply disinfectant to both hands & on the hand gloves. (70% IPA as disinfecting solution)
 After the primary change, personnel should go to their respective departments. (Please
Inspect yourself in the mirror)
 Wear nose/face mask when entering the primary packaging or manufacturing area.
Color Coding of Uniform
Color-coding of uniform can be used to identify personnel and their department. A suggested color-
coding scheme for the first change room and primary change room is as indicated below:
 Brown/Blue – Engineering department
 Moss green/Disposable – Visitors, Guests
 Steel Grey – Warehouse personnel
 White Apron– QA personnel, Office Staff, Production. Quality Control
 Sky Blue lint-free - Manufacturing/Sampling/Dispensing – (Primary change room)
 Brown lint-free – for employees in primary area of the Engineering department.

STERILE GOWNING
BEGINS

QUALITY ASSURANCE
QUALITY CONTROL
NON-STERILE PRODUCTION

STERILE PRODUCTION

SANDAL & SHOE USED IN THE PHARMACEUTICAL INDUSTRY: (In some cases, sandals are not allowed *)
QUALITY CONTROL (USE SHOE IF QC PREMISE IS
NEAR TO THE PRODUCTION AREA)
QUALITY ASSURANCE
WARE HOUSE
RESEARCH & DEVELOPMENT
QUALITY CONTROL
PRODUCTION
NOTE: This write-up is for knowledge and acquiring ideas on pharmaceutical gowning. Do not use this
whole article or any part on the website or publication.

Gowning in the pharmaceutical industry

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