- To lay down a procedure for washing and inspection of surgical hand gloves.
- This SOP is applicable for washing and inspection of the surgical gloves used in production area in formulation plant of pharmaceutical company.
- Production Officer / Executive.
- Production Head and QA head shall be accountable for compliance of SOP.
- SOP : Standard Operating Procedure.
- WFI : Water for injection
- SS : Stainless Steel
- 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
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores,
Date Revision Number
Reason for Revision
– 00 New SOP
- 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