SOP on Procedure for storage of sterilized rubber stoppers in aseptic area .

May 10, 2017February 2, 2023 Pharma Editor

Objective
To lay down the procedure for storage of sterilized rubber stoppers in aseptic area.

Scope
This SOP is applicable for storage procedure of sterilized rubber stoppers in aseptic area Production dry powder Injectable facility.
Responsibility
Production officer / Executive.
Accountability
Production Head shall be accountable for the compliance of SOP.
Abbreviations
SOP : Standard Operating Procedure
SS : Stainless Steel

Procedure
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
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History

Date Revision Number
Reason for Revision

– 00 New SOP

Date	Revision Number	Reason for Revision
–	00	New SOP

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SOP on Procedure for storage of sterilized rubber stoppers in aseptic area .

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