Entry to Aseptic area of Pharmaceuticals

Entry to Aseptic area of Pharmaceuticals is different from other entries of the pharmaceuticals department which is described here.

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Objective Entry to Aseptic area of Pharmaceuticals:

This procedure outlines the methods to be followed by all personnel entering into sterile area, when area is in operation.

General

1) All persons entering sterile areas are responsible for complying with this procedure.

2) The sterile area supervisor is responsible that all persons entering the sterile area have been instructed in the proper gowning procedure.

3) Articles of apparel to be worn in the sterile areas are to be cleaned and sterilized.

4) The wearing of excessive or heavy make-up  (cosmetic) is prohibited in sterile areas.

5) Before entering any sterile environment, personnel should understand the responsibilities of their position and know clean room techniques and system operations.

6) No one who is physically ill, especially with stomach or respiratory disorder or skin lesions may enter sterile rooms or sterile areas.

Procedure:

1. Remove street shoes and wear rubber slipper in preparation room.
2. Wash hands, face and feet in sink with germicidal soap.
3. Enter the changing room of sterile Area leaving slippers outside the area.
4. Take off street clothes and hang under U.V. Lamp.
5. Cross over the bench to come in clean area of changing room.
6. Clean hands with 70 Alcohol. Apply generously to palms of both hands and changing thoroughly until no residone remaines.
7. Pick up a set of sterile uniform and unirap
8. Never Mix Sterile Uniforms With (Unsterilized Uniforms).
9. Again clean hands with 70% Alcohol before touching sterile uniform in the same method as done in step – 6.
10. Wear sterile white uniform taking care to touch only the inside surface of uniform to prevent contamination of the outside. Put on sterile white suit in following sequence ( clean hands with 70% Alcohol at every sequence and every time take care to touch only the inside surface of every part of uniform) :
1. Trouser and Gown
2. Head Mask 
3. Nose Mask
4. Shoe Covers 
5. Surgical Gloves.
11. Enter Buffer Room, pick up a wrapped jump suit and unwrap and wear it. (Same procedure and precaution given in step 6 and 9).
12. Put on a pair of surgical glove.
13. Swab gloved hands with 70% alcohol and enters to main filling room. After going into filling room again gloved hand with 70% Alcohol and straight away goes to the working place. If hands touched with anything swab hands again with 70% Alcohol. Start filling operation.
14. Do not touch any part of body with wall, door or filling machine etc.
15. Do not move fast or excessively in the sterile area.
16. Do not talk much in sterile Area especially in filling room.
17. Use fresh sterlized uniform after every interval.

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