USP <1116> and its Implications for Measuring Microbial Recovery Rates

Authors: Gilberto Dalmaso, Ph.D. and Claudio Denoya, Ph.D. 

The recently revised United States Pharmacopoeia (USUSP-1116-Microbial-Limits-Recovery-Rates.pngP) 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).

Instead of using the microbial limits currently endorsed by aseptic guidances (2-4) which are based on CFU, <1116> proposes CRR values expressed in maximum allowed percentage of contaminated samples. The proposal is generating a broad range of discussions among pharmaceutical professionals regarding potential implications of these changes.

The paper covers

- Main changes from the previous revision (title, scope, aseptically filled product, room classes, risk assessment, air changes, the case for CRR)

- Recommendations when using CRR

- Case Study: Garment Contamination Rates

- Conclusions on CRR

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