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SOP for washing and inspection of surgical hand gloves.

  • Objective:
  • To lay down a procedure for washing and inspection of surgical hand gloves.
  • Scope
  • This SOP is applicable for washing and inspection of the surgical gloves used in production area in formulation plant of pharmaceutical company.
  • Responsibility
  • Production Officer / Executive.
  • Accountability
  • Production Head and QA head shall be accountable for compliance of SOP.
  • Abbreviation
  •  SOP : Standard Operating Procedure.
  • WFI :  Water for injection
  • SS  :   Stainless Steel
  • Operation:
    • Issue the surgical hand gloves from the store and keep in change parts Room as per the requirements of glove size (8” and 14”)
    • Bring of required no. of gloves to the equipment washing area.
    • Tear of the outer packet and take out the gloves.
    • Check the gloves for any physical damage .Reject the defective hand gloves.
    • Dip the surgical gloves in purified water for 5 minutes.
    • Scrub the gloves gently with hands.
    • Dip the gloves in fresh purified water.
    • Take out the gloves and check for leakages by filling the glove with purified water.
    • Reject gloves having leakages.
    • Rinse the good inspected gloves in WFI.
    • Hand gloves which are to be used in sterile area shall be placed in perforated SS box for further sterilization.
    • Hand gloves which are to be used in controlled area shall be sent to respective area in SS perforated trays.
    • Collect the rejected surgical gloves in a polybag and send for further disposal.
    • Record the details in the format for washing and inspection record of surgical hand gloves).
    • Forms and Records (Annexures)
    • Washing and inspection record of surgical hand gloves – Annexure -1
    • Distribution
    • Master copy –   Quality Assurance
    • Controlled copies- Quality Assurance, Production, Quality Control, Stores,
    • History
      Date Revision Number
      Reason for Revision
      00 New SOP

Annexure -1

  • Washing and inspection record of surgical hand gloves
    Date Size of hand gloves No of  gloves washed and inspected No of hand gloves rejected Inspected by Checked by Remarks

    (if any)

     

     

     

     

 

    

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