To lay down a procedure for entry, exit and gowning procedure in aseptic area.
This SOP is applicable for only qualified persons for entry, exit and gowning in aseptic area
Officers or above – Production
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA : Quality Assurance.
S.S. : Stainless Steel
6.1.1 Entry to the aseptic area is restricted to authorized qualified personnel only as per the list of authorized and qualified personnel displayed on the entry of aseptic area.
Persons suffering from any infectious, ailments like cold, cough, fever, injury or any other diseases etc are not allowed to enter the aseptic area.
Persons with unhygienic conditions are not allowed to enter the aseptic area.
Females are not permitted to enter the aseptic area.
6.2 Entry into sump area:
Press the door-interlocking button, open the door and enter the sump area.
Remove the plant footwear and keep them in provided shoe rack inside the almirah.
Remove the plant uniform.
Keep the uniform in the almirah.
6.3 Entry into first change room:
Press the door-interlocking button, open the door with elbow and enter the first change room.
Fill the SS mug with disinfectant solution (Kept in SS container), Keep feet in SS tray and pour the disinfectant solution on to feet. Ensure that the solution dose not splash out of tray.
Step on the protect mat provided in the change room.
Rinse the hands with disinfectant solution
While disinfecting the hands, ensure that disinfectant solution should not splash on the floor.
Take the clean primary garment from almirah (shirts, trousers, caps & booty)
Wear the cap.
Wear shirt and then trouser. While wearing the trouser ensure that it does not touch the floor.
Tuck the shirts in trouser.
Wear the booties.
6.4 Entry into second change room:
Press the door-interlocking button, open the door with elbow and enter the second change room.
Sanitize the hands with disinfectant solution
Take the pre-sterilized hand gloves (8”) kept in S.S. perforated box
Wear the hand gloves, while wearing the hand gloves ensure that outer surface of the gloves should not touch with bare hands and sanitize it
6.5 Entry into third change room
Press the door-interlocking button, open the door with elbow and enter the third change room.
Open the garment cubicle and take the bag consisting of sterile secondary garment
Wear the garment in following sequence strictly
Wear the headgear without touching the outer surface
Wear the boiler suit by taking care to avoid contact with floor. Ensure that loose ends of head cover are tucked inside the boiler suit. Close the chain of the boiler suit
Pick up one Goggle from the garment storage cubicle and wear in front of the mirror
Sit on the S.S. cross over bench
Tie up one booty and cross the leg on other side of the bench
Tie up the other booty without touching the bench by hand and cross over the bench
Discard the empty bag in the waste bin provided in the change room
Look into the mirror to check the proper gowning and ensure that no body part is exposed
6.6 Entry into the buffer change room
Press the door-interlocking button, open the door with elbow and enter the buffer change room and stand for a moment
Sanitize the gloved hand with disinfectant solution
Pick up the secondary hand gloves (14”) from the SS box provided and wear over the primary hand gloves
Sanitize the gloves hand with disinfectant solution
Enter the sterile passage by pushing the door with elbow and stand for a moment
6.7 Entry into cooling zone / vial filling room
Walk slowly and enter the vial filing room by pushing the door with elbow through sterile passage or cooling zone by pushing the door with elbow
6.8 Entry into sampling room
After coming to sterile passage push the door of sampling area and enter into the Sampling room
6.9 Exit procedure from aseptic area
6.9.1 Exit from filling room / cooling zone
Press the door-interlocking button and pull the door of filling room or cooling zone and enter the sterile passage
6.9.2 Exit from the sampling room
Pull the door of sampling room and Enter into the sterile passage
6.9.3 Entry into Exit Buffer room
Press the door-interlocking button and pull the door of exit buffer room
Enter the exit buffer room
Wait for about 30 seconds in the buffer room
6.9.4 Enter into the return change room
Press the door-interlocking button and pull the door of return change room
Enter the return change room
Remove the goggles and keep them S.S. tray for further sanitization
Remove the secondary gloves and dispose them in bin provided
Remove the secondary garments
Keep the head gear, boiler suit and booties in the bin specified there for further washing
Remove the primary garment
Keep the primary cap, booties, shirt and trouser in the bin specified for further washing
Remove the hand gloves and keep them in bin for disposal
6.9.5 Entry into the sump area
Press the door interlocking button and pull the door of sump area
Enter the sump area
Wear the plant uniform and plant foot wear
6.9.6 Entry into corridor
Press the door interlocking button and push the door of corridor
Enter in the corridor
7.0 Forms and Records (Annexures)
Declaration Sheet – Annexure I
Entry and exit record of Aseptic area. – Annexure II
8.0 References (if any):
SOP of SOP.
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production Aseptic (display & record).
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