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SOP for cleaning of sterilizing tunnel

  • Objective:
  • To lay down a procedure for Cleaning of sterilizing tunnel.
  • Scope
  • This SOP is applicable for Cleaning of sterilizing tunnel for Production dry powder Injection facility.
  • Production Officers / Executive.
  • Responsibility
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • WFI : Water for Injection.
  • S.S. : Stainless Steel
  • IPA  : ISO Propyl Alcohol
  • Procedure
  • Cleaning of the tunnel shall be carried out every day at the end of day’s operation. Also the cleaning is done every weekend when there is no operation.
  • Ensure that day production is over.
  • Main switch off the control panel of tunnel.
  • Allow the tunnel to cool down up to room temperature.
  • Ensure that the shutter of the tunnel from the side of vial filling room is closed.
  • Open the vertical side panels of the Sterilizing Tunnel.
  • Visually inspect the conveyor and inside of the tunnel for presence of any particulate or glass pieces.
  • If observed, any particulate and glass pieces clean it by vacuum cleaner.
  • Lift the dampers of the Sterilization zone.
  • Clean the inside chamber of sterilizing tunnel using vacuum cleaner.
  • Remove the horizontal SS plate below the conveyer from base of machine to clean the conveyer from lower side.
  • Clean the SS plate by wet mopping using lint free duster soaked in WFI.
  • Clean the SS plate by wet mopping using lint free duster soaked in IPA.
  • Clean the remote portion of the sterilizing zone by lint free duster (Soaked in WFI) tied at the end of the SS rod.
  • Start conveyor rotation (Bypass the control panel for manual control)
  • Mop the sterilizing tunnel conveyor from upper and lower sides with lint free duster soaked in WFI followed by dry moping with lint free dry duster.
  • Mop the sterilizing tunnel conveyor from upper and lower sides with lint free duster soaked in IPA followed by dry moping with lint free dry duster.
  • Stop conveyor rotation.
  • Clean the Sterilizing Tunnel outer surface using dry lint free duster.
  • Clean the control panel outer surface using dry lint free duster.
  • Change the status of equipment status board to write “Cleaned Ready for Use”.
  • Record the details of cleaning operation in the operation and cleaning record as per SOP and get it checked by concerned Supervisor / Officer.
  • 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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