The need for a rapid sterility test method has been an ongoing need for the pharmaceutical industry in sterile manufacturing. However, the validation of rapid technology has long been considered too challenging for many QC micro labs. This mentality continues to gradually shift through the ongoing collaboration and sharing of validation strategies.
Utilizing an amplified ATP-bioluminescence detection method, this presentation will share how equivalency, specificity, and limit of detection was demonstrated against the compendial method for membrane filtration, bringing the 14-day incubation test down to six days.
Senior Product Manager
Charles River Microbial Solutions
Brice Chasey has over 10 years of industry experience in rapid microbial detection methods. He uses his experience with validation, implementation, and interacting directly with industry analysts to bring rapid detection systems to routine use. Brice now manages the Celsis rapid microbial detection product portfolio at Charles River.