H2O2 sterilizer validation
Sterilization with H2O2 is a low-pressure, non toxic and low-temperature process with temperatures typically between 6°C and 60°C, that uses vaporized aquarious Hydrogen Peroxide to reduce the level of infectious agents. Aquarious H2O2 is introduced to the vaporizer bowl, heated by RF and feeded into the main chamber under vacuum generating plasma. Process is preferred on products that either cannot withstand the heat of typical autoclave sterilization e.g. plastic or have diffusion-restricted spaces such as low lumened medical devices. The main physical parameters to be monitored are pressure (1-20 hPa), delivered RF energy, H2O2 concentration and temperature (45-55°C).
The total length of the process can vary depending on the goods to sterilize, but typical cycles are between 1 and 2 hours, another reason why this low temperature sterilization method is preferred to EtO sterilization.
Hydrogen Peroxide Sterilization is completely secure and environment friendly. During and after the sterilization process only water vapor generates so no toxic residue. Consumables are not explosive, inflammable or toxic.
Hydrogen peroxide sterilizers have only few drawbacks. Since hydrogen peroxide is a strong oxidant, there are material compatibility issues and e.g. paper products cannot be sterilized because of a process called cellulostics, in which the hydrogen peroxide would be completely absorbed by the paper.