Building A Science- And Risk-Based Bio-Decontamination Strategy

The 2022 revision of EU GMP Annex 1 changed how decontamination is judged: a "validate once, monitor loosely" cycle no longer fits a documented, lifecycle-based contamination control strategy. This webinar offers a practical framework for isolators and barrier systems, tracing how regulatory expectations have evolved and tying them to the microbial science behind hydrogen peroxide inactivation, D-values, and log reduction. It then covers technology selection across VHP, AHP, and NHP, cycle development, worst-case justification, and a validation strategy built on IQ/OQ/PQ and biological, chemical, and enzyme indicators.

Watch to see how each decision connects to the next.