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.
Vaporized hydrogen peroxide is a low-temperature antimicrobial process used in two materially different applications: These applications use the same active chemical but do not support the same claim. Medical-device sterilization is developed and controlled to render a defined product sterile….
Validation of a vaporized hydrogen peroxide process must demonstrate that the defined system, cycle, load, and operating conditions consistently achieve the intended microbiological result. The required evidence depends on the process claim: The distinction affects the microbiological endpoint, biological-indicator strategy,…