Microbial Quality of Dehydrated Media Used in the Sterility Testing of Immunobiological Medicinal Products

Abstract

Medicinal products fail sterility testing if visual observation shows the growth of microorganisms that manifests itself as turbidity, sedimentation, flocculation and other changes in the growth medium. A key factor allowing robust determination of changes in the culture that may be suspected of contamination is the quality of growth media used, namely their transparency, and absence of foreign matter detectable by microscopic examination of the growth media smears. The presence of such foreign matter makes it especially difficult to interpret the results of testing of immunobiological products, namely live bacterial vaccines, because they cause turbidity of the media due to their specific composition. The article dwells upon the results of testing (in terms of Transparency and Microbial content) of dehydrated growth media recommended by the State Pharmacopoeia of the Russian Federation, 13th ed., General monograph 1.2.4.0003.15 for sterility testing of immunobiological medicinal products. The study revealed the presence of microorganisms, including pathogenic ones, in the growth media. In view of the fact that certificates of analysis and technical documentation accompanying components of growth media and dehydrated growth media produced by most national and foreign manufacturers do not contain any data on the acceptable levels of microorganisms it is argued that these products have to be tested for microbial content. The study also investigated the ways of improving the quality of commercial dehydrated growth media at the preparation stage.