USP <1116> and its Implications for Measuring Microbial Recovery Rates
The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbial Control and Monitoring of Aseptic Processing Environments Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (CFU).
This paper covers
- Main changes from the previous revision
- Recommendations when using CRR
- Case Study
- Conclusions on CRR
Authors: Gilberto Dalmaso, Ph.D. and Claudio Denoya, Ph.D.
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