Microbiological Quality Control of Biotechnological Pharmaceuticals

Abstract

A new approach to microbiological analysis of several pharmaceuticals, in particular, those that can be used in manufacturing sterile medical products, is presented. The proposed approach was verified using a series of 23 samples of various products, three of which were obtained by biotechnological methods. The scheme includes inoculation of samples with test strains followed by isolation and analysis of the contaminants. Validation results showed that the amount of products for microbiological analysis could be reduced to 3 g, which was sufficient for obtaining reliable results. Tryptic soy broth was used as the solvent (diluent) and enrichment broth for microbe growth.