1.0 OBJECTIVE:To lay down a Procedure is to provide guidelines for Sterility testing of compressed air, Nitrogen & Carbon dioxide.
2.0 SCOPE:This procedure is applicable for Sterility testing of compressed air, Nitrogen & Carbon dioxide.
4.0 ACCOUNTABILITY:Head QA & QC
5.0 PROCEDURE:5.1 Clean the air sampling apparatus as per SOP for cleaning of glassware for microbiological testing.
5.2 Fill 100 ml 0.1% peptone water in sampling apparatus, wrap the apparatus and other glassware’s and accessories required for testing of compressed air, and sterilize by autoclaving at 121°C and 15 psi pressure for 30 minutes (peptone water sterilization for 20 minutes), refer SOP for Sterilization by Autoclaving.
5.3 Prepare the FTM and SCDM media as per SOP for preparation of culture media. Dispense the media in 100 ml test tubes.
5.4 Sterilize the tubes containing 100 ml media by autoclaving at 121°C and 15 psi pressure for 20 minutes; refer SOP for Sterilization by Autoclaving.
5.5 After autoclaving, allow the material cool to room temperature and pre incubate the FTM and SCDM as per media preparation.
5.6 Transfer the sampling apparatus in a closed SS container to sterile area through Pass box and personnel must be enter into personnel entry air locks of sterile area as per SOP for Entry Exit Procedure for Sterile Area.
5.7 Take the sampling apparatus inside manufacturing area from material entry and remove the wrapping.
5.8 Connect the compressed air to inlet of sampling apparatus, start slowly compressed air supply by opening the stopcock of the outlet port for 10 minute.
5.9 Stop the compressed Air and disconnect the line from apparatus, and immediately seal the inlet and outlet of apparatus with sterile cotton plug and aluminium foil and same procedure will be follow for Nitrogen and Carbon dioxide.
5.10 Follow the exit procedure and come out from the manufacturing area.
5.11 Transfer the apparatus to sterility room through hatch box; ensure the UV light is OFF during transfer.
5.12 Carry out sterility test by membrane filtration method using 100 ml sample as per SOP for Sterility test.
5.13 Incubate the tubes for 14 days and visually examine the tubes daily and its conclusion for macroscopic evidence of growth.
5.14 If no evidence of growth observed in any of the tube the sample to be examined for the test complies with the test for sterility.
5.15 If evidence of microbial growth is found in the test the sample examined does not comply with the test for sterility.
5.16 Carry out the failure investigation as per SOP for investigation of sterility failure.
5.17 Precaution5.17.1 Sampling compressed air, Nitrogen and Carbon dioxide for sterility test should be done with care.
5.17.2 Only Authorized person can enter in sterility room.
5.17.3 Any material used in the sterility operation or inside sterility room should be autoclaved properly.
5.17.4 Clean the waste solution reservoir immediately after sterility operations and mop the outer surface of the reservoir with 0.2m filtered 70% IPA with sterile mope.
6.0 ABBREVIATIONS:SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
NA : Not Applicable
IPA : Isopropyl Alcohol
FTM : Fluid Thioglycolate Medium
SCDM : Soybean casein digest medium
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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