Standard ISO 22441:2022 Sterilization of health care products
Low temperature vaporized hydrogen peroxide
Requirements for the development, validation and routine control of a sterilization process for medical devices
was published in August 2022.
In January 2024, the FDA published a document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile", which reclassifies hydrogen peroxide vapor sterilization to A category. Hydrogen peroxide vapors belong to the same robust sterilization category A as
Dry heat sterilization
Sterilization by moist heat or steam
Ethylene oxide sterilization in fixed, rigid chambers
Radiation (e.g. gamma, electron beam)
In category B the FDA includes:
Ozone
Flexible bag systems (e.g. ethylene oxide in a flexible bag system, diffusion method, injection method)
There are still innovative methods of sterilization, among which the FDA lists:
Vaporized peracetic acid
High intensity light or pulse light
Microwave radiation
Sound waves
UV-light
For each category of sterilization method, the FDA requires specific documents, which are explicitly listed in the instruction.
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (fda.gov)
In conclusion: for medical devices, hydrogen peroxide vapor is a full-fledged sterilization method. Compared to sterilization with ethylen oxide, it has the advantage of significantly lower toxicity.
Question: will hydrogen peroxide vapor be recognized as a sterilization method also for manufacturing of medicines?