Standard Operating Procedure of Entrance Of Worker In The Liquid Injectable Sterile Area of Pharma is describe in this post.
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1 PURPOSE
1.1 It is established to control each and every step for entrance of workers in the Liquid Injectable Sterile Area
2 SCOPE
2.1 It is applicable in the Liquid Injectable Manufacturing Section
3 RESPONSIBILITIES & AUTHORITIES
3.1 Concerned Officer Production
3.2 Supervisor
3.3 Machine Operators
3.4 Workers
4 REFERENCE
4.1 NA
5 DEFINITIONS
5.1 List of GMP Techniques
6 PROCEDURE
6.1 GOWNING PROCEDURE
6.1.1 FIRST CHANGE ROOM
6.1.1.1 Put OFF the UV light before entering the first change room.
6.1.1.2 Remove the factory clothing and hang them neatly on the hooks provided in this room.
6.1.1.3 Keep your under garments on.
6.1.1.4 Use your elbow to open the door of second change room.
6.1.1.5 Put on the UV light of the first change room while leaving.
6.1.2 SECOND CHANGE ROOM
6.1.2.1 Spray your hand with antiseptic solution (70% Isopropyl alcohol).
6.1.2.2 Select a pair of gloves, slip in the left-hand glove slowly and other right hand glove in a same manner and spray 70% Isopropyl alcohol on the gloves.
6.1.2.3 Use your elbow to the open door of the third change room.
6.1.3 THIRD CHANGE ROOM
6.1.3.1 Select a pre-sterilized mask and wear it.
6.1.3.2 Select one pack of sterilized garments, open the pack and take out the snood.
6.1.3.3 Wear the snood taking care to tuck in all hair.
6.1.3.4 Wear the sterile uniform properly leaving no part of body open.
6.1.3.5 Wear your shoes.
6.1.3.6 Discard the hand gloves in the plastic drum placed in this room.
6.1.3.7 Spray your hands with antiseptic solution (70% Isopropyl alcohol).
6.1.3.8 Select a packet of gloves.
6.1.3.9 Slip on the left-hand glove slowly and tuck in the uniform sleeve in it.
6.1.3.10 Repeat the action with right hand glove.
6.1.3.11 Spray the glove hands with 70% Isopropyl alcohol and dry gloves properly by using hot air dryer provided in this room.
6.1.3.12 Open the next door leading to the sterile room using your elbow.
6.1.3.13 Put ON the UV light while leaving the third change room.
6.1.3.14 Enter the filling room.
6.2 DE-GOWNING PROCEDURE
6.2.1 FIRST EXIT ROOM
6.2.1.1 Pull the door of the corridor.
6.2.1.2 Use first exit room just for passing from corridor to second exit room.
6.2.1.3 Enter the second exit room by opening the door with elbow.
6.2.2 SECOND EXIT ROOM
6.2.2.1 Put OFF the UV light.
6.2.2.2 Remove the entire used uniform, mask, shoes etc. and carry to the first change room in a bag.
6.2.2.3 Put ON the UV light by leaving the room.
6.2.2.4 Pull the door of the first change room.
6.2.3 FIRST CHANGE ROOM
6.2.3.1 Enter to the first change along with bag filled with used sterile clothing.
6.2.3.2 Put OFF the UV light while entering into the room.
6.2.3.3 Wear your stored factory clothing.
6.2.3.4 Open the door and put ON the UV light while leaving the first change room
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