Vaporized Hydrogen Peroxide (VHP) process validation standard ISO 22441 was published in 2022 and recognized by the United States (US) FDA and many European countries. In Jan 2024, the US FDA announced VHP as an Established Category A sterilization method.
There is also ongoing work for VHP sterilizer equipment standard EN 17180 and ISO 11138-6 for biological indicators. VHP is important for enabling sterilization of temperature and/or radiation sensitive medical devices and combination devices, such as pre-filled syringes with a sensitive drug product.
The focus of this article is to provide information on the available and near future regulatory guidance documents for validating a VHP sterilization process, describe the sterilization process variables and characteristics, and assess the key process validation requirements. Specific attention is paid to considerations for sensitive pre-filled syringe product applications, key device properties, material limitations, and manufacturing site arrangements.
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Published in Pharmind
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