This section addresses the principles and validation of vapor hydrogen peroxide processes used for surface and enclosure sterilization in GMP environments. It covers cycle development, concentration control, distribution studies, biological indicator qualification, material compatibility, and requalification strategy to ensure effective microbial inactivation and repeatable decontamination performance.
1. Introduction Vapor Hydrogen Peroxide VHP sterilization is a widely adopted low-temperature sterilization technology used in pharmaceutical and sterile manufacturing environments. It is primarily applied for the decontamination and sterilization of isolators, RABS, material transfer chambers, pass-through units, and occasionally…
1. Introduction VHP sterilization validation demonstrates that a vapor hydrogen peroxide system consistently achieves the required level of microbial inactivation under defined operating conditions. Validation is not limited to initial qualification. It is a lifecycle-controlled activity that includes: In regulated…