Microbiological tests microorganisms

Perform microbiological challenge studies to determine the degree of process lethality provided by the sterilization cycle. The microorganisms most frequently utilized to challenge steam sterilizer cycles are Bacillus stearothermophilus and ATCC 7953. The Kaye validator equipped with 12 (minimum) thermocouples and biological indicators (10 ) shall be positioned in the detected cool points of the chamber and condenser. After the sterilization cycle is complete, the B.I s are recovered and subjected to microbiological test procedures. 

E. coli is recommended. The microbiological assessment of preservatives is required when preservatives are used in a pharmaceutical product to control microbial bioburden. The test microorganisms and methods for evaluating the efficacy of the preservative in pharmaceutical products are described in the general chapter on preservative effectiveness tests [26]. 

Microbiological tests where appropriate, e.g., bioburden, absence of specific microorganisms... 

Microbiological testing should be conducted on each lot of API required to be free of objectionable microorganisms. Appropriate testing should also be conducted on each lot of API required to be pyrogen free or with a specified endotoxin limit (e.g., APIs intended for use in the preparation of parenteral drug products). 

The earliest methods for vitamin analysis were based on animal bioassays. Later, when it was recognized that vitamins are essential for certain microorganisms, microbiological tests were evolved. The chemical methods for determination of water-soluble vitamins were quite common in the past, before the development of more specific and selective analytical methods. 

Microbiological methods employ the paper disc-plate assay. For rifomycin B, Siz y-lococcus aureus ATCC 6538 is used as the test microorganism. The agar medium is buffered at pH 5.0, since a low piH enhances the sensitivity of the test, fevoring the transformation of the inactive rifamycin B into ri mycins O and S. The dose-response curve... 

Microbiological Extraction of biotin Low equipment Test microorganism... 

Microbiological methods use test microorganisms such as bacteria,... 

These methods were the first developed for biotin analysis and are still accepted as official methods because of their high sensitivity (nanogram level). The species most commonly employed for biotin determination are some Lactobacilli such as L. arabinosus (ATCC 2112), L. plantarum (ATCC 8014), and L casei (ATCC 7469) Ochromonas danica, Neurospora crassa, and Saccharomyces cerevisae (ATCC 4228) are also employed. Kloeckera brevis (ATCC 9774) is useful for a radiometric-microbiological determination based on the measurement of " C02 formed by the test microorganism from " C-labeled L-methionine. 

As microbiological methods incorporate viable test microorganisms, predictability of the outcome is not always clear and subject to many environmental influences that may impact on a given response. Hence, it is of the utmost importance that parameters such as plant collection, validation of laboratory equipment, chemical analysis, and various intricacies of antimicrobial investigations be carefully defined. 

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