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2018年6月4日—ThemethodologyforthebioburdentestiscommonlymodifiedfromUSP<61>,USP<71>SterilityTests,andwater-testingguidelines, ...

By Crystal M. Booth[1], PSC Biotech

In-process bioburden testing is performed to analyze the quantities and types of microorganisms in the manufacturing process. For the data to be accurate, the method must be properly developed and validated. Trending of the data is useful because it can be used to monitor adverse trends, seasonal fluctuations, and even the microbial load on sterilizing filters. But, that is not all. There is often a story with the data -- a story that could tell the tale of the most probable root cause during an out-of-specification investigation and that could reveal evidence of inadvertent contamination or undetected festering biofilms.

This article looks at in-process bioburden testing and the importance of establishing accurate data and routinely monitoring the data for adverse trends. It also discusses the importance of evaluating periodic data spikes and...