How to validate hydrogen peroxide vapor decontamination?
- Marta Ugochukwu Monincová
- Feb 8, 2024
- 1 min read
In a previous blog post, I mentioned that there is an ISO standard and an FDA document for the sterilization of medical devices with hydrogen peroxide vapor.
According to EU GMP Part I Annex 1 Manufacture of Sterile Medicinal Products
4.36 Where fumigation or vapour disinfection (e.g. Vapour-phase Hydrogen Peroxide) of cleanrooms and associated surfaces are used, the effectiveness of any fumigation agent and dispersion system should be understood and validated.
In addition to the documents listed in the older blog, a possible procedure and theory for parameter calculations is presented in the article: Theoretical Analysis of the Condensation of Hydrogen peroxide Gas and Water Vapor as used in Surface Decontamination
by David Watling, Cian Ryle, Matthew Parks, and Matthew Christopher
Link to the article here:
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