Pharmaceutical products must be shown to be free of potentially harmful indicator organisms specified by Pharmacopeia. Some of the most routinely tested microorganisms include Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Salmonella spp. The traditional microbiology methods as described in United States Pharmacopeia (USP) chapter <62>1, European Pharmacopoeia (EP) 2.6.132 and Japanese Pharmacopeia (JP) 35.23 for microbiological examination of non-sterile products are time-consuming, and may take up to seven days to obtain results. The typical procedure involves preincubation of samples in a non-selective culture medium and then sub-culture on several selective culture media for further enrichment and identification. Furthermore, preparation, maintenance and growth promotion of several different culture media is time-consuming and costly. In some cases, waiting for microbiology results becomes a bottleneck in the product release cycle. In addition, other microorganisms such as Burkholderia cepacia are gaining notoriety due to their frequent isolation as a contaminant from products released to the public posing hitherto unrecognized risk4.
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