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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.
      • 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

No of Boxes for each Batch Quantity to be Sampled per batch
01 to 100 boxes 02 % or 2 boxes ,whichever is greater From each box one pair of Gloves to be sampled
More than 100 boxes 4 boxes From each box one pair of Gloves to be sampled

 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, Pin hole and record in Annexure -01.

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. “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 – Annexure – I

  • References(If any):

GTP- (Sterility Test)

SOP of Sampling and Testing of Sterile Raw materials and Finished Product for Chemical and microbiological analysis)

SOP of Handling of Microbiological Data Deviation in Microbiology Laboratory

  • Revision History:
  • Not applicable
  • Abbreviations:

GRN : Good received Note

COA : Certificate of Analysis

COQ: Certificate of Quality

QC : Quality Control

%: Percentage

NA:Not Applicable

Annexure – I

Physical verification of Sterile Surgical Gloves

     Date of Observation:                           Batch Number:                            A.R. Number:

S.No Physical Parameter Observation Done By Checked By Remarks
01 Torn or Defects        
Powder on Glove  
Stick itself  
Pin hole Test  
02 Torn or Defects        
Powder on Glove  
Stick itself  
Pin hole Test  
03 Torn or Defects        
Powder on Glove  
Stick itself  
Pin hole Test  
04 Torn or Defects        
Powder on Glove  
Stick itself  
Pin hole Test  
05 Torn or Defects        
Powder on Glove  
Stick itself  
Pin hole Test  

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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