Standard Operating Procedure of Entrance in Sterile Area in Phamrmaceuticals Plant is describe in this post.
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1 PURPOSE
1.1 In the sterile products manufacturing personal hygiene play main role in the end products quality.
2 SCOPE
2.1 It is applicable in sterile area.
3 RESPONSIBILITIES & AUTHORITIES
3.1 Machine Operator / Helper
3.2 Production Supervisor
3.3 Section Incharge entry to sterile area(gowning de-gowning)
3.4 Quality Assurance Inspector
3.5 Production Manager
3.6 Q.A Manager
4 MATERILAS AND EQUIPMENT
4.1 Germ free suit, S.S Box, gloves, mask, shoes. 70 % IPA
5 PROCEDURE
Wash hands with liquid soap and dry them by using clean hand drier before entering 1st Airlock.
5.1 1ST AIRLOCK
GOWNING PROCEDURE
5.1.1 Remove the factory uniform and hang them neatly on hangers s.s racks for factory uniform in the 1st Airlock.
5.1.2 Put off factory shoes and wear area shoes.
5.1.3 Rinse your hands with the sterile antiseptic solution.
5.1.4 Open the door of the 2nd Airlock.
5.1.5 Step directly into the 2nd Airlock.
DE-GOWNING
- Remove shoe cover, germ free suite, and put them into the s.s racks shoe S.S Box.
- Put off area shoes and place them in racks provided and wear factory shoes.
- Remove the disposable mask and the hand-gloves, and bring them out of the 1st Airlock along with the S.S box.
- Put the S.S box in the laundry receptacle and the disposable facemask and the hand gloves in the other receptacle provided.
5.2 2ND AIRLOCK
GOWNING PROCEDURE
5.2.1 Select a pair of sterilized gloves and check indicator and sterilization / expiry date. Slowly slip in the left hand glove and then the right hand glove and spray sterile 70 % Isopropyl Alcohol on gloved hands.
5.2.2 Dry gloved hands.
5.2.3 Select a pre-sterilized disposable mask and wear it.
5.2.4 Select one packet of sterilized garments. Check the sterilized indicator and date of sterilization / expiry.
5.2.5 Wear the Germ-free suit tucking the inner dress inside the neck of the suit.
5.2.6 Carry the shoes cover in your hand and open the door to the 3rdAirLock
5.2.7 Enter the 3rdAirLock.
DE-GOWNING PROCEDURE
- After entering the 2ndAirLock pick up the empty uniform S.S box.
- Enter the 1stAirLock by pulling open the door of the 2ndAirLock.
5.3 3RD AIRLOCK.
GOWNING PROCEDURE
5.3.1 Sit on the pass over bench kept in the 1st half of the 3rdAirLock and wear your Shoes cover.
5.3.2 Discard the hand gloves in the plastic receptacle provided in 3rdAirLock.
5.3.3 Spray your hands with the sterile antiseptic solution in use provided.
5.3.4 Select a packet of sterilized surgical gloves. Check the sterilization indicator and date of sterilization / expiry.
5.3.5 Slip on the left-hand glove and tuck in the Germ free suite sleeve in it.
5.3.6 Repeat the action with the right hand glove.
5.3.7 Spray the gloved hands with sterile 70 % IPA provided.
5.3.8 Open the door leading to the filling room.
5.3.9 Enter the filling room.
DE-GOWNING PROCEDURE
- Pull open the door of the2nd airlock ad enters the 2nd airlock.
PRECAUTION TO BE TAKEN IN GOWNING
5.3.10 Do not touch any surface with hands, touch or handle only what is necessary.
5.3.11 Do not make rapid movements.
5.3.12 Do not make unwanted movements.
5.3.13 Wrist Watch and jewelry is not allowed.
5.3.14 Germ free suite sleeves must be tuck inside the disposable gloves so that no skin is visible.
5.3.15 Trouser bottom must be inside the shoe cover
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