Whether manufacturing an aseptically manufactured injectable product or an oral tablet, it is critical to understand the microbiological attributes. From a safety perspective, pathogenic contaminants must not be introduced at any point during manufacturing of oral dose products. Improper microbiological controls can lead to product contamination and patient death.

Pharmacopeial compendia and regulatory authorities (FDA & ISO) provide a significant amount of guidance related to microbiological examination of pharmaceutical products: a search for Microbiological Examination in the USP results in 67 currently official documents. Traditional microbiological testing is known to be a time-consuming process, often requiring from weeks to months to complete.

Technological progress is leading to breakthrough technologies that vastly streamline microbiological testing and identification, with rapid sterility testing systems that reduce the time required for sterility testing from weeks to hours. In this webinar, we will discuss how recent technological developments allow for rapid micro testing and identification, focusing on the genotypic identification method and equipment that can simplify and make the identification of contaminants more robust.