IMA Life at the 2025 PDA Pharmaceutical Microbiology Conference

IMA Life is pleased to take part in the 2025 PDA Pharmaceutical Microbiology Conference, celebrating 20 years of progress in microbiological science. This global event brings together the microbiology community to explore key developments in pharmaceutical microbiology, including contamination control, emerging technologies, and regulatory trends. This year’s theme, Microbial Resilience: Today’s Response, Tomorrow’s Plan, underlines the importance of managing current challenges while building strong strategies for the future. The agenda features case studies, regulatory updates, and focused sessions.

Don’t miss IMA Life’s presentation:

“The Hidden Threat in VHP Cycle Validation: Quantifying the Impact of Rogue/Late-Positive Biological Indicators Using Statistical Models and Monte Carlo Simulations” • presented by Giacomo Guidi (Aseptic Process Expert and Strategic Marketing, IMA Life) on Monday October 27th at 1:45 PM.

Spore-based biological indicators (BIs) are critical for validating vaporized hydrogen peroxide (VHP)-based decontamination cycles, offering a robust measure of microbial inactivation. However, the presence of “rogue” or “late-positive” BIs that resist to the VHP sporicidal effect beyond expected levels, can lead to false-positive results, potentially compromising the reliability of validation protocols. This presentation explores the “rogue” dynamics and the statistical impact of rogue BIs within Performance Qualification (PQ) procedures for aseptic isolators using VHP. By modeling the PQ rules mathematically, the study quantifies how even a low incidence of rogue BIs can exponentially increase the probability of PQ failure. Three key PQ criteria are analyzed:

• (A) the presence of multiple positive BIs in a single location,
• (B) exceeding a pre-defined threshold of positive locations (e.g. 5%),
• (C) recurrence of positive results in the same location across cycles.

The analysis demonstrates that a rogue BI mean rate exceeding 0.3% significantly elevates the risk of PQ failure, even in otherwise effective decontamination cycles. A Monte Carlo testing approach is used to provide realistic failure probabilities, highlighting the need for BIs batch rogue-tests or alternative mitigation strategies. The proposed methodology serves as a predictive tool to optimize validation protocols and ensure successful qualifications of aseptic isolators.

LOCATION

Grand Hyatt Washington

1000 H Street, NW, WASHINGTON, DC 20001, USA