Sampling and testing of Sterile surgical Gloves

Sampling and testing of Sterile surgical Gloves

Objective:

• To lay down the procedure for Sampling and testing of sterile surgical gloves.

Scope:

• This SOP is applicable for sampling and testing of sterile surgical gloves.

Responsibility:

• Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves.
• Executive/ Officer shall be responsible for ensuring the compliance to the procedure.
• Head–Microbiology shall be responsible for overall compliance of the procedure.

Accountability:

• Head – Quality Control and Head – Quality Assurance shall be accountable for overall compliance of SOP.

Procedure:

Sampling Procedure:

• Sampling of sterile surgical gloves shall be initiated after receiving the “GRN” from
• Warehouse personnel shall send the GRN with COA/COQ to Quality Control Microbiology department for sampling and testing.
• Microbiologist or above shall verify the GRN with COA/COQ then enter the material details in sample inward Record and allot Analytical Reference Number as per SOP.

Sample Quantity:

For physical Verification 

Table-01 – Sample Quantity for Physical verification

 For Microbiological testing:

From each Batch, only one pair of Gloves shall be sampled for Microbiological testing (Sterility testing)

Physical verification:

• Check the intact condition of the received gloves as per manufacture COA. If parameter does not meets as per manufacture COA/ COQ then received batch of gloves shall be rejected
• Verify the physical condition (torns, defects), powder on gloves, stick itself, Pinhole and record in Annexure
• In case any defects observed in physical conditions like torns defects, powder on glove, stick itself, Pin hole in the received batch of gloves then it shall be rejected.
• Perform the pinhole test of gloves by pouring water into the gloves and check for any holes.
• Release the gloves for routine usages on the basis of physical verification, manufacture COA/ COQ,
• Parallelly perform the sterility testing of each batch of received gloves for routine verification only.

Microbiological testing:

• The sterility test shall be performed for sterile surgical gloves by Direct inoculation method as per current version of GTP
• Inoculate one received sterile glove pair into pre-incubated Soyabean Casein Digest Medium and Fluid Thioglycollate Medium separately and incubate for not less than 14 days.
• After incubation, record the observation details in current version of Format”Analytical data sheet of Direct Inoculation Sterility Testing”.
• If growth observed initiate the Microbiological Data Deviation as per current version of SOP.

Note: If any discrepancy observed in test result initiate root cause identification.

List of Annexure:

Physical verification of Sterile Surgical Gloves

References(If any):

• • Sterility Test
  • Sampling and Testing of Sterile Raw materials and Finished Product for Chemical and microbiological analysis
  • Handling of Microbiological Data Deviation in Microbiology Laboratory

Revision History: NA

Abbreviations:

• GRN : Good received Note
• COA : Certificate of Analysis
• COQ: Certificate of Quality
• QC : Quality Control
• %: Percentage
• NA:Not Applicable

END OF SOP

Physical verification of Sterile Surgical Gloves

     Date of Observation:                                           Batch Number:

     A.R. Number: