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SOP for cleaning of PVC flaps of Laminar Air Flow

SOP for cleaning of PVC flaps of Laminar Air Flow

  • To lay down a procedure for cleaning of PVC flaps of Laminar Air Flow.
  • Objective:
  • Scope
  • This SOP is applicable for cleaning of PVC flaps of Laminar Air Flow.
  • Responsibility
  • Production operator / Technician – responsible for operation of cleaning of PVC flaps of Laminar Air Flow.
  • Production officer / Executive – to ensure that operation of cleaning of PVC flaps of Laminar Air Flow is carried out as per SOP.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  •  Abbreviations
  • SOP : Standard Operating Procedure.
  • S.S. : Stainless Steel
  • WFI : Water For Injection
  • PVC : Poly Vinyl Chloride
  • Procedure
  • Cleaning of PVC flaps of Laminar Air Flow shall be done before starting the work or whenever necessary.
  • Both sides of PVC flaps shall be cleaned by wet mopping soaked in WFI, using lint free duster.
  •  After wet mopping both sides of PVC flaps shall be cleaned using dry lint free duster.
  • This SOP shall be applicable for PVC flaps of Laminar Air Flow units located in following locations.
    Sr.      No.                 Location                  Room Name
    1 Vial washing machine LAF Vial washing and sterilization room
    2 Bung processor  cum steam sterilizer LAF Equipment Washing & Sterilization Room
    3 Vial sealing machine LAF Vial sealing Room

    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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