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

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

  • 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

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