Gowning Procedure in Pharmaceuticals Company

“Gowning” is a set of garments worn while in a clean room or other controlled environment. The
level of gowning required is a function of the product or process, and its cleanliness
requirements.
Gowning can cover some or all of the following:
 Head / hair
 Beard / mustache
 Face
 Torso / Upper body
 Legs / pants
 Feet / shoes
 Hands

1. GOWNING HOSSEN M. FARUK Executive, Quality Assurance B . Pharm (Hon's), MS Pharm Tech.

2. W hat is Gowning? Gowning: The process of wearing special garments in order to control particulate contamination.

3. Importance of Gowning: “Gowning” is a set of garments worn while in a clean room or other controlled environment. The level of gowning required is a function of the product or process, and its cleanliness requirements. Gowning can cover some or all of the following: • Head / hair • Beard / mustache • Face • Torso / Upper body • Legs / pants • Feet / shoes • Hands The gowning is designed and intended to cover all necessary parts of your clothed-body to prevent hair, skin cells (epithelia) and other particles (particulate) on oneself from shedding into the clean room environment and/or contaminating the product.

4. 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 fingernail, jewelry , wrist watch , cosmetics , hair spray , perfumes and carrying mobile . Personnel in clean area shall wear clean area attire at all times during production hours. Special Instruction of Gowning:

5. 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. Cleanroom: Know what class of cleanroom you’re entering.

7. Change Room: A changing room, locker room, dressing room (usually in a sports, theater or staff context) or change room (regional use) is a room or area designated for changing one's clothes. Changing rooms are provided in a semi-public situation to enable people to change clothes in privacy, either individually or on a gender basis. Separate changing rooms may be provided for men and women, or there may be a non-gender specific open space with individual cubicles or stalls. Sometimes a person may change his or her clothes in a toilet cubicle of a washroom. Many changing rooms include washrooms and showers.

8. Personnel routes are strictly maintained Primary change room (Non classified) Grade D support room Grade D area 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. Gowning Personnel Routes:

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