Title 13. DETAILED STUDY OF STERILITY TESTING OF DIFFERENT PHARMACEUTICAL PREPARATIONS.pdf ✅

PHARMD GURU Page 3 CULTURE MEDIA: The following media are used for tests of sterility. The composition of media used for sterility test is given in Table 11.2. 1) Fluid thioglycollate medium (FTM): It is used with clear fluid products. FTM is primarily intended for the culture of anaerobic bacteria; however it will also detect aerobic bacteria. If more than the upper one-third of the medium has acquired a pink colour, the medium may be restored once by reheating in a water bath or in free flowing steam until the pink colour disappears and cooling rapidly, taking care to prevent the introduction of non-sterile air into the container. When ready for use, not more than the upper one-tenth of the medium should have a pink colour. 2) Alternative thioglycollate medium (ATM): It is used with turbid or viscid products and for devices having tubes with small lumina. ATM is incubated in such way that, to assure anaerobic conditions. 3) Soyabean casein digest medium (SCDM): SCDM is suitable for the culture of both fungi and aerobic bacteria. Medium 1 and 2 are adjusted to pH 7.1 ± 0.2, medium 3 is adjusted to pH 7.3 ± 0.2 and sterilized by autoclaving at 121°C for 20 minutes. Anaerobic conditions are required for growth of some microbial species (Table 11.3).
PHARMD GURU Page 4 SUITABILITY OF MEDIA: The media used for sterility test should comply the following tests.  Sterility of media: Incubate portions of the fluid thioglycollate medium/alternate thioglycollate medium at 30 to 35°C and soyabean casein digest medium at 20 to 25°C for not less than 14 days and observe the presence of the growth of microorganisms in a sterile media.  Growth promotion test: Test each autoclaved load of media for its growth promoting qualities by separately inoculating duplicate test containers of each medium with about 100 viable microorganisms of each of the strains listed in Table 11.3. The test media are satisfactory if clear evidence of growth appears in all inoculated media containers within specified time. The sterility test is considered invalid if the test medium shows inadequate growth response. TEST FOR BACTERLOSTATIS END FUNGISTASIS (TEST FOR SAMPLE TO BE TESTED AS PER IP 1996): Prepare cultures of bacteria and fungi from the strain of microorganisms mentioned in Table 20.3. Inculate the sterility test media with about 100 viable microorganisms using volumes of media listed in Table 11.4. Add the specific