Equipment and Process Validation for an Industrial VH2O2 Sterilization Application: Poster Presented at PDA Week 2025.

Abstract

Sterilization of sensitive drug delivery devices such as pre-filled syringes can be significantly enable by implementing Vaporized Hydrogen Peroxide VH2O2 (VHP) Low Temperature Sterilization for the process application. Utilizing VH2O2 has been widely used in biodecontamination of e.g., Pharmaceutical manufacturing spaces, isolators and lyophilizers for over 30 years, and terminal sterilization of sensitive combination products and other medical devices by VH2O2 also increasingly for the past 20 years. The 2022 published ISO 22441 for process validation, adoption by FDA and several other countries and FDA moving VH2O2 sterilization to Established Category A are strengthening its position. The near future EN 17180 for VH2O2 sterilizer equipment will provide specific guidance for implementing to pharmaceutical manufacturing process. Further, the work on VH2O2 specific biological indicator standard ISO 11138-6 and upcoming revision of the AAMI TIR 17 for guidance on material compatibility for sterilization modalities, will provide additional help and guidance. This presentation will provide guidance on all key elements of equipment and process validation of VH2O2 sterilizers and developed processes and recommendation on steps of application implementation, and also puts focus on key requirements of conformance and related materials and documentation, in the light of typical product applications sterilized by VH2O2.