November 1, 2017 07:01:27 PM

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

Written by Katie Sternberg

The revised United States Pharmacopoeia (USP) chapter Microbial Control and Monitoring of Aseptic Processing Environments includes a thorough description, definition and guidance on microbial control and monitoring in 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, which are based on CFU, <1116> proposes CRR values expressed in the maximum allowed percentage of contaminated samples. The proposal is generating a broad range of discussions among pharmaceutical professionals regarding potential implications of these changes.

It is important to note that <1116> is a “general information” chapter, and as such, it “provides information and recommendations for environments where the risk of microbial contamination is controlled through aseptic processing”. Therefore, the chapter in its current format provides recommendations not yet adopted and not enforceable by the U.S. FDA or any other government agency. This clarification is important because the recommendation on the adoption of CRR is generating a positive debate that will likely require further discussion and clarification before any enforcement occurs. If adopted, it is hoped that a harmonized approach by U.S., European and Japanese authorities will take place to avoid disparity of values for microbial limits.

Learn more about the main changes from the previous revision by downloading the entire paper, USP <1116> and Its Implications for Measuring Microbial Recovery Rates.