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SOP on cleaning of Liquid filling machine (Watson Marlon )

  • Objective:
  • To lay down the procedure for cleaning of liquid filling machine (Watson Marlon).
  • Scope
  • This SOP is applicable for the procedure of cleaning of liquid filling machine shall be accountable for the compliance of SOP.
  • Responsibility
  • Production Officers / Executive.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • WFI : Water for Injection
  • Procedure :
  • Stop the liquid dosing from the touch screen of the liquid filling machine after the filling activities are over Transfer the goggles to the controlled area for cleaning and sanitization.
  • Put the filling machine on emergency mode.
  • Remove the power cord of the liquid filling machine from the back panel of vial filling and bunging machine     .
  • Open the guard of the vial filling & bunging machine.
  • Dismantle the removable parts of the liquid filling machine like silicon tubes silicon tube holders, communicator chord etc.
  • While removing silicon tubes keep the face of the filling nozzle upwards so that there is no spillage of the  solution transfer  the extra solution from the tubes into a glass is  no spillage of the  solution transfer  the extra solution from the tubes into a glass
  • Inspect the filling machine base for any spillage of the liquid solution in case found immediately removes with disinfectant solution.
  • Transfer the change parts like silicon tubes to the cooling zone through pass box no  and to controlled area through pass box no .
  • Rinse the change parts with WFI (2-3 times) under equipment cleaning LAF in controlled area. Send the rinse water sample to QC Dept. for trace water analysis by LBPC and Endotoxin test.
  • After receiving the report sterilize these change parts with machine parts load.
  • Clean the machine assembly with WFI soaked in a sterile lint free duster.
  • Disinfect the machine assembly with disinfectant solution (verosil pharma 20 %).
  • Dry the machine assembly by wiping with sterile lint free duster.
  • Record the details of operation, cleaning and preventive maintenance of the machine in equipment log book as per SOP and the BMR .Get the details checked by the Production officer/supervisor
  • 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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