Microbial Limit Test in Pharmaceutical Products: An Overview

The microbial limit tests are designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in pharmaceutical substances or in the samples. Since, the pharmaceutical products deals with the formulation of various dosage form which ultimately be used by the human for alleviating certain kind of ailments to treat the dreadful diseases. Therefore, the test should be performed in all the dosage form to ensure that the formulation 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.

MICROBIAL LIMIT TEST IN PHARMACEUTICAL PRODUCTS: AN OVERVIEW

DHURIA, AMITA1* & DWIVEDI, SUMEET*

1.Institute of Environment Management & Plant Science, VikramUniversity,

Ujjain, M.P.-India2, 2.Chordia Institute of Pharmacy,Indore, M.P.-India  

                                                                           ABSTRACT

The microbial limit tests are designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in pharmaceutical substances or in the samples. Since, the pharmaceutical products deals with the formulation of various dosage form which ultimately be used by the human for alleviating certain kind of ailments to treat the dreadful diseases. Therefore, the test should be performed in all the dosage form to ensure that the formulation 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.

 * Corresponding AuthorMs. Amita Dhuria

Institute of Environment Management & Plant Science,

VikramUniversity, Ujjain, M.P.-India

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Mob. No. 09893478497

                                                                       INTRODUCTION

The microbial limit tests are designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in pharmaceutical substances or 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. For the test, use a mixture of several portions selected random from the bulk or from the contents of a sufficient number of containers. If test specimens are diluted with fluid medium, the test should be performed quickly. 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.

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