PDA Southeast Chapter Sponsored Webinar with Charles River Labs

Demonstrating Equivalency and Limit of Detection for a Rapid Sterility Method via ATP-Bioluminescence

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 6-days.

Objectives of this abstract

This presentation provides details on the test method performed, twelve challenge organisms used, and the statistical analyses and their results that were obtained.

The audience will be provided a potential validation strategy that can be used and options for pursuing the same approach and testing protocols.

Speaker information

Brice Chasey is a Senior Product Manager with over 10 years of industry experience in rapid microbial detection methods. Across many years of validation and implementation, interacting directly with industry analysts bringing rapid detection systems to routine use, Brice now manages the Celsis rapid microbial detection product portfolio at Charles River. He received a Bachelor of Science in Microbiology from Arizona State University. He currently resides in Phoenix, Arizona, working for the Microbial Solutions division of Charles River Laboratories.