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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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