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SOP for Post Sterility Growth Promotion Test


Standard operating procedure to perform the growth promotion test after the completion of sterility test.

1.0  PURPOSE

       To lay down procedure for Post Sterility Growth Promotion Test of Media after completion of Sterility Test.

2.0  SCOPE

       This SOP is applicable for performing Post Sterility Growth Promotion Test of Media after completion of Sterility.

3.0  RESPONSIBILITY

       Trained Microbiologist is responsible to perform the test as per SOP and Section In-Charge is responsible for conformance to SOP.

4.0  ACCOUNTABIULITY

       Head of Department

5.0  PROCEDURE

5.1  Frequency

5.1.1  This test shall be performed for each product on annual basis.
5.1.2  The test shall be performed preferably on higher strength presentation and if performed on higher strength than testing of lower strength presentations is not required.
5.1.3  The test can be performed together three sets of canisters of three batches if the sterility of all the three batches is being completed within a week’s time. In such cases store the canisters at below 25°C till the test is initiated. If three batches are not available at a time as above, then test can be performed at different points by inoculating one challenge organism for each medium at a time.

5.2  Culture Inoculum

5.2.1  Use standardized inoculum prepared as per SOP of following organisms for each media.
5.2.2  Fluid Thioglycollate Medium (FTM):
•  Staphylococcus aureus ATCC 6538
•  Pseudomonas aeruginosa ATCC 9027
•  Clostridium sporogenes ATCC 11437 or 19404
5.2.3  Soybean Casein Digest Medium (SCDM):
•  Bacillus subtilis ATCC 6633
•  Candida albicans ATCC 10231
•  Aspergillus brasiliensis (Aspergillus Niger) ATCC 16404
5.2.4  Along with above organisms, use an environmental isolate for each medium.
5.2.5  The inoculum used shall be 10 – 100 CFU.

5.3  Test Procedure

5.3.1  After completion of sterility test, take media canisters to biosafety cabinet and disinfect the tubing near
5.3.2  With help of sterile syringe inoculate 10 – 100 CFU of the challenge organism to the media by piercing the needle into canister tubing.
5.3.3  Repeat above step for all organisms for each medium if three batches are taken at a time. If single set of canister is taken then inoculate one organism to SCM and one organism to FTM as per 5.2. In the later case, the challenge organism is to be changed in sequence to include all the organisms.
5.3.4  Incubate the canisters at respective conditions i.e., SCM at 22.5 ± 2.5°C and FTM at 32.5 ± 2.5°C for not more than 5 days.

Related: Incubation Conditions for Common Media used for Fungus and Bacteria

5.3.5  Observe the inoculated canisters for growth.
5.3.6  Acceptance Criteria and Interpretation of Results
5.3.6.1  Clear visible growth should be observed within 3 days for bacterial culture and within 5 days in case of yeast and fungal cultures.
5.3.6.2  If clear visible growth is not obtained within 5 days for both bacterial and fungal cultures, then the test is considered invalid.
5.3.6.3  Invalid post sterility growth promotion test may be repeated once and if visible growth is not obtained in repeat test, then sterility test method should be modified and revalidated.
Post Sterility Growth Promotion Test (Stasis Test): Test to evaluate the ability of the sterility test medium after completion of 14 days incubation to promote growth or microbial recovery when inoculated with small numbers of organisms. This test is intended to demonstrate that the media support the growth for the full incubation period.

6.0  ABBREVIATIONS:

6.1  SOP – Standard operating procedure
6.2  CFU – Colony forming unit
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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