We’re pleased to announce that we will be presenting at the PDA Midwest Chapter 18th Annual Microbial Contamination and Control Conference in Northbrook, IL taking place at the Hilton Chicago/Northbrook Hotel May 13 -14, 2026.
Join our Presentation
Abstract:
Sterility testing remains a critical component of pharmaceutical and medical device manufacturing. Traditional compendial sterility methods, while well established, require extended incubation periods of up to 14 days, creating challenges for products with short shelf lives, just‑in‑time manufacturing models, and accelerated release timelines.
Rapid sterility testing, enabled by validated rapid microbiological methods (RMM), offers a scientifically sound and regulatory‑accepted alternative to conventional testing. By leveraging technologies such as ATP‑bioluminescence, rapid methods provide earlier and more objective detection of microbial growth, significantly reducing time to results while maintaining sensitivity and reliability comparable to compendial approaches.
This presentation will highlight the key benefits of rapid sterility testing, including shortened incubation timelines, improved decision‑making for batch release, reduced inventory holding risk, and enhanced operational efficiency. Case examples will demonstrate how rapid sterility testing supports modern manufacturing strategies without compromising data integrity or regulatory compliance. Alignment with USP <1223>, Ph. Eur. 5.1.6, and PDA TR 33 regulations and validation expectations will also be discussed, emphasizing how rapid methods can be successfully implemented as alternative or supplemental sterility testing strategies.
