Bioburden Determinations

Bioburden Determinations

Bioburden Validations

Bioburden quantitation does not always capture 100% of the viable population on a medical device or pharmaceutical article. There are a number of reasons for this, including extraction effectiveness and media variations. It is therefore imperative that a bioburden validation be performed to define the recovery efficiency. One of two methods is generally used: 1) inoculation, or 2) exhaustive extraction. This recovery efficiency is then applied to routine analyses to provide a more accurate estimation of the original product bioburden. Methods are consistent with ANSI/AAMI/ISO 11737-1. 

Routine Bioburden Determinations

Bioburden testing is performed to determine the total microbiological population on a medical device or pharmaceutical article prior to sterilization. Available test methods permit the determination of aerobic (vegetative or spore-formers) organisms, anaerobic organisms (vegetative or spore-formers), and/or fungi (yeast and molds) present. These data can be utilized in the development of product sterilization cycles and further, monitoring the continued effectiveness of GMP controls in place. Methods are consistent with ANSI/AAMI/ISO 11737-1 and ANSI/AAMI/ISO 11737-3.

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