USP 1116 & Implications of 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). Key Learning Objectives:

• Main changes from the previous revision
• Recommendations when using CRR
• A case study
• Conclusions on CRR