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Standard Operating Procedure For Entering And Leaving To First Change Room

by Pharmadocx Consultants

PURPOSE:  To  lay down procedure for Entering and leaving to 1st  Change Room.

RESPONSIBILITY :

1.Production Manager

PROCEDURE

1st  Change Room

1. Remove the factory attire and them neatly in the almirah provided in the 1st change

2.  Rinse your hands with the sterile antiseptic solution (i.e savlon)  in use as per  cycle in basin provided for the purpose.

3. Open the door of the 2nd change room. Enter the 2nd change room.

  1. Switch of the UV tube when in and switch on when you are out.

DE- GOWNING PROCEDURE

  • Remove the booties, boiler suit and snood and put them in the uniform bag.
  • Remove the disposable mask and the hand-gloves, and bring them out of the 1st change room along with the uniform bag.

PURPOSE:  To  lay down procedure for Entering and leaving to IInd  Change Room.

RESPONSIBILITY :

1.Production Manager

PROCEDURE

GOWNING PROCEDURE

2nd Change Room

1.  Select a pair of sterilized gloves and check indicator and sterilization/expiry date. Slowly slip in the left hand gloves and then the right hand glove and spray sterile 70 % Isopropyl Alcohol on gloved hands.

2   .Dry gloved hands.

3 Select a pre-sterilized disposable mask and wear it.

4. Select one packet of sterilized garments. Check the sterilization indicator and date of sterilization expiry.

  1. Open the pack and take out the snood.
  2. Wear the snood taking care to tuck in all hair in front of the mirror provided.
  3. Next, wear the boiler suit tucking the snood inside the neck of the suit.
  4. Enter the 3rd Change room.
  1. DE-GOWNING PROCEDURE

1.After entering the 2nd change room, pick up the empty uniform bag kept in the 2nd change room.

2. Enter the 1st change room by pulling open the door of the 2nd change room.

3. Ensure that the UV light is switched ‘ON’ before you leave the 2nd change room.

PURPOSE:  To  lay down procedure for Entering and leaving to IIIrd  Change Room.

 RESPONSIBILITY :

1.Production Manager

PROCEDURE

GOWNING PROCEDURE

3rd Change Room

1.  Step into the 2nd half of the 3rd change room and wear your booties.

2.  Discard the hand gloves in 3rd change room.

3.  Spray your hands with the sterile antiseptic solution in use provided.

4.  Select a packet of sterilized rubber gloves. Check the sterilization indicator and date of sterilization / expiry.

5.   Slip on the left-hand glove and tuck in the boiler suit sleeve in it.

6.   Repeat the action with right hand glove.

7.   Spray the gloved hands with sterile 70% Isopropyl Alcohol provided.

8.   Check complete gowning in front of mirror provided.

9    Open the door leading to filling room.

10    Enter the Filling Room.

DE-GOWNING PROCEDURE

11 Pull the door of the 3rd change room and then enter into the 2nd change room.

12 Remove slippers in the 2nd half of the change room.

13 Pull open the door of the 2nd change room and enter the 2nd change room after putting the UV lamp of the 3rd change room ‘ON’.

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

             (Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

12 June 2023

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