A REVIEW ON MICROBIOLOGIAL ASSAY

Microbiological assays are designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in the samples. The test should be performed in all the samples to ensure that the it is free from any micro-organism and it also ensure that it will not going to harm the human body as concern to the micro-organism.

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INTRODUCTION

Microbiological assay are designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in the samples. It includes tests for total viable count (bacteria and fungi) and specified microbial species (Escherichia coli, Salmonellla, Pseudomonas aeruginosa and Staphylococcus aureus). It must be carried out under conditions designed to avoid accidental microbial contamination of the preparation during the test. When the test specimens have antimicrobial activity or contain antimicrobial substances must be eliminated by means of procedure such as dilution, filtration, neutrilization or inactivation. In performing the test, precautions must be taken to prevent biohazard. According to USP the test is designed to determine total aerobic microbial count and yeast and mould count. This test demonstrates that product is free from Staphylococcus aureus, E. coli, Pseudomonas aeruginosa, C. albicans and A. niger.

PREPARTION OF THE TEST SOLUTION

Phosphate Buffer (pH 7.2), buffered Sodium Chloride-Peptone Solution or Fluid medium used for the test is used to dissolve or dilute the specimen.
Water Soluble products: Dissolve 10 g or dilute 10 ml of the preparation being examined, unless otherwise specified in buffered sodium chloride-peptone solution pH 7.0 or any other suitable sodium medium shown no antimicrobial activity under conditions of test and adjust the volume to 100 ml with same medium. If necessary, adjust the pH to about 7.0.
Products insoluble in water (non-fatty): Suspend 10 g or 10 ml of the preparation being examined unless otherwise specified in buffered sodium chloride-peptone solution pH 7.0 or any other suitable sodium medium shown no antimicrobial activity under conditions of test and adjust the volume to 100 ml with same medium. If necessary, divide the suspension mechanically.
A suitable surface-active agent such as 0.1 % w/v of polysorbate 80 may be added to assist the suspension of poorly wettable substances. If necessary, adjust the pH to about 7.0.
Fatty products: Homogenise 10 g or 10 ml of the preparation being examined unless otherwise specified, with 5 g of polysorbate 20 or polysorbate 80. If necessary, heat to not more than 40 C.

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