Suitability and Equivalency Testing for Rapid Microbial Methods


Thursday, July 2, 2020
14:15 CEST


Live Online
Sterility testing solutions using rapid microbiology for testing pharmaceutical products in accordance with USP 71, FDA, and Ph. Eur 2.6.1 methods


Regulators are showing increased support for using rapid microbial methods (RMMs) for sterility testing. Rapid methods provide objective results in a fraction of the time of traditional ones, allowing product to be released faster and safer. Before a lab can implement, however, it needs to prove the RMM’s suitability and equivalency to the compendial method. Join us for a discussion on guidelines and validation parameters for RMMs and how to approach suitability testing and validation for Celsis® products.



lucia ceresa
Lucia Ceresa, PhD
Senior Technology and Market Development Manager
Charles River Laboratories