Identifying microbes in non-sterile facilities

Published: 3-May-2012

Assuring compliance to the regulatory guidelines for microbial monitoring during the production of pharmaceuticals and nutraceuticals requires a thorough understanding of the regulatory environment and the different methodologies available for microbial identification and differential strain typing

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Microbial identification is key for non-sterile facilities producing pharmaceuticals or nutraceuticals. Accugenix reviews modern identification methods for use in environmental monitoring programmes

For manufacturers of pharmaceuticals, dietary supplements or nutraceuticals, the presence of bacteria, filamentous fungi and yeasts are usually a cause for concern. However, a well-designed environmental monitoring (EM) programme should detect the presence of these micro-organisms before product contamination occurs.

When bacterial or fungal isolates are recovered from a production facility, it is important to be able to identify accurately the organism to the species, and possibly strain level, to track the potential origin of the contamination, mitigate it and avoid delays in product release or to complete investigations.

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