Process Validation for VHP (VH2O2) Sterilization

The recent move by the FDA to reclassify VHP sterilization as an Established Category A technology is a significant development for makers of single use medical devices and packaged, prefilled syringes. VHP’s ongoing technology journey and the ever-increasing growth of innovative medical devices are well aligned for the benefit of the industry. The next step for VHP sterilization standards is EN 17180 - Sterilizers for medical purposes — Low temperature vaporized hydrogen peroxide sterilizers — Requirements and testing, currently estimated by the end of 2024. There is also a new work item for the ISO 11138-6 standard for VHP biological indicators. Regardless of being validated per ISO 22441 or ISO 14937 - the same basic guideline is followed.

This presentation mainly provides insight and guidance on how to approach VHP sterilization process validation per ISO 22441, but also provides an overview to VHP sterilization technology and applications and current developments in regulatory field.