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Bioburden Testing

Bioburden testing gives an estimated count of the microbial population of a product prior to sterilization. Manufactured and purchased components, employees, as well as the manufacturing environment all contribute to the microbial load of a given sample. Routine testing of a random sampling of production lots, statistical trend analysis and limit setting, coupled with fast and accurate results allows clients to react to microbiological issues before they impact manufacturing of present sterilization challenges. For products sterilized via radiation, bioburden testing ensures accurate dosing, and, thus, a properly sterilized device. The staff at GTI, in accordance with all compendia standards, will work with the client to tailor an extraction procedure that ensures accurate and reliable data in making manufacturing and sterilization decisions. Tests for the enumeration of aerobic, anaerobic, and spore-forming bacteria, as well as yeasts, molds, and fungi are available.

 

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