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, PhD
Senior Technology and Market Development Manager
Charles River Laboratories