USP 1116 & Implications of Measuring Microbial Recovery Rates
The recently revised United States Pharmacopoeia (USP) chapter Microbial Control and Monitoring of Aseptic Processing Environments Chapteris 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).
- Main changes from the previous revision
- Recommendations when using CRR
- A case study
- Conclusions on CRR
Gilberto Dalmaso, PhD
Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Life Science Scientific Officer for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe, Asia and United States, and is an ISO 9001 and HACCP quality system auditor.