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

Presenter

Gilberto Dalmaso

PhD - Senior Advisor and Pharma Customer Advisory Team Manager

Gilberto has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. Today he is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States. Dr. Dalmaso is the Global Consultant and Subject Matters Experts Team Manager for Particle Measuring Systems. In this role and with his team of subject matters experts, he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.