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SOP for cleaning of vial washing machine

  • Objective:
  • To lay down a procedure for cleaning of vial washing machine.
  • Scope
  • This SOP is applicable for cleaning of vial washing machine.
  • Responsibility
  • Officers – Production.
  • Accountability
  • Production Head.
  • Procedure
  • The cleaning is done after the day’s work is over or whenever necessary. Ensure that the left over vials are removed from the machine.
  • Remove glass vials if any from the in-feed conveyor, in-feed SS guides, upload taflon guides, vial lifter, washing stations, and out-feed conveyor.
  • Start the machine as per the instructions given in the SOP on Operation of Vial Washing Machine and visually check the spray of water from the nozzle. If the spray from any nozzle is found blocked clean the nozzles.
  • Cleaning of the spray nozzles.
  • Open side cover.
  • Remove the manifold.
  • Remove the nozzle.
  • Clean the manifold with purified water and compressed air jet.
  • Clean the blocked nozzle with compressed air jet.
  • Fix the nozzle back to their original position.
  • Cleaning of WFI water tank
  • Open side cover
  • Remove tank cover.
  • Drain water from WFI water tank by opening drain valve.
  • Clean the tank by wiping with clean lint free cloth.
  • Wash with purified water.
  • Dry the tank using compressed air and lint free cloth.
  • Cleaning of purified water tank
  • Open side cover.
  • Remove tank cover.
  • Drain the water from purified water tank by opening drain valve.
  • Clean the tank by wiping with clean lint free cloth
  • \Wash with purified water
  • Dry the tank using compressed air and lint free wipe
  • Cleaning of re-circulated water tank
  • Open side cover.
  • Remove tank cover
  • Drain the water from re-circulated water tank by opening drain valve
  • Clean the tank by wiping with clean lint free cloth.
  • Wash with purified water
  • Dry the tank using compressed air and lint free cloth.
  • Cleaning of Teflon pockets, vial lifters, infeed and outfeed conveyer, guides and PVC tubings.
  • Open the side cover.
  • Remove the base plate on which the pockets are mounted.
  • Clean the pockets by wiping with clean lint free cloth.
  • Wash with purified water.
  • Fix the base plate back to its original place.
  • Open the cover from front side with the help of special keys and clean the vial lifter by wiping with clean lint free cloth.
  • Clean the in-feed and out-feed conveyor with lint free wipe dipped in purified water.
  • Clean the Teflon and stainless steel guides with lint free cloth dipped in purified water.
  •   PVC tubings are to be dismantled and cleaned with hot purified water.
  • Record the cleaning details in Equipment operation, cleaning and maintenance log  book
  • Frequency:
  • For cleaning – Daily.
  • 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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