- To lay down the procedure for storage of sterilized rubber stoppers in aseptic area.
- This SOP is applicable for storage procedure of sterilized rubber stoppers in aseptic area Production dry powder Injectable facility.
- Production officer / Executive.
- Production Head shall be accountable for the compliance of SOP.
- SOP : Standard Operating Procedure
- SS : Stainless Steel
- Ensure the sufficient Number of Sterilized lint free bags available before starting rubber stoppers sterilization cycle.
- After Completion of rubber stoppers sterilization cycle, Open the door of bung processor cum steam sterilizer by pressing “ door open “ button on the panel in aseptic area.
- Bring SS trolley to bung processor cum steam sterilizer and fix it by locks provided.
- Slide the rubber stopper carriage on SS trolley and fix the locks.
- Safely remove perforated SS partitions carrying sterilized rubber stoppers from carriage.
- Unload sterilized rubber stoppers in the pre-sterilized lint free bags in aseptic area.
- Store these bags carrying sterilized rubber stoppers on the SS rack in cooling room, before transferring to filling area.
- Close the door of bung processor cum steam sterilizer by pressing “ door close” button on the panel in aseptic area.
- Keep the SS trolley in Cooling room of aseptic area.
- Forms and Records (Annexures)
- Not Applicable
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP
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