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Appl Environ Microbiol. 1968 December; 16(12): 1919-1923
Copyright © 1968 American Society for Microbiology. All Rights Reserved.

Method for Microbiological Testing of Nonsterile Pharmaceuticals

Microbiological Laboratory, J. R. Geigy S. A., Basel 21, Switzerland

ABSTRACT

A method for testing nonsterile pharmaceutical preparations for their microbial content is described. As far as possible, only solid culture media were used to obtain quantitative results. Aqueous and water-soluble products were tested with membrane-filter techniques. Nonfilterable products were first emulsified or suspended and the homogenate was used for examination. In both procedures, the total number of colonies is determined for aerobic bacteria and fungi. Tests for certain undesirable microbial groups were conducted with selected media. The method described is applicable for finished products, bulk products, raw materials, and active ingredients.