Growing regulatory pressure, environmental concerns, and capacity constraints associated with ethylene oxide (EtO) sterilization have intensified the need for alternative sterilization modalities that can reduce risk and strengthen medical device supply chains. Vaporized hydrogen peroxide (VH₂O₂) sterilization has emerged as a viable next-generation solution, offering effective microbial inactivation, improved sustainability, and increased operational resilience.

In 2024, the U.S. Food and Drug Administration reclassified VH₂O₂ as an Established Category A sterilization process, with ISO 22441:2022 providing the framework for process development, validation, and routine control. VH₂O₂ sterilization demonstrates broad material compatibility and robust efficacy against a broad spectrum of microorganisms, while producing no toxic residuals and decomposing into environmentally benign byproducts.

This presentation reviews the regulatory landscape, validation expectations, and risk management principles necessary to support VH₂O₂ sterilization and reduce reliance on EtO.