Material Compatibility With Vaporized Hydrogen Peroxide (VHP) Sterilization

By G. McDonnell

Various sterilization methods (including gamma irradiation an  ethylene oxide) have been widely used for terminal medical device sterilization. No single method offers the perfect sterilization solution for every application. Steam sterilization may be overly aggressive to device components or packaging materials (may form stress cracks in metal components) and cannot be used for heat-sensitive devices. Gamma irradiation or E-beam sterilization are reliable alternatives for low temperature sterilization, but are generally only performed on a contract basis at a limited number of facilities. Contract sterilization can also include the expense of transportation and storage of a product. Ethylene oxide sterilization is an alternative for integration into a manufacturing line, but cycle times are relatively long (particularly poststerilization aeration) and toxicity/carcinogenicity issues are often a significant concern. A newer process is low temperature, Vaporized Hydrogen Peroxide (VHP®) point-of manufacture sterilization. This method uses hydrogen peroxide vapor under vacuum to sterilize medical devices. In addition to rapid sporicidal activity, VHP sterilization demonstrates low toxicity, and rapidly decomposes into the non-toxic by-products of water vapor and oxygen, offering a safe and rapid alternative for point-of-manufacture sterilization.

Biodecontamination Systems have been widely used and validated in industrial applications for over 10 years. They are used for the biodecontamination of sterility testing environments, production filling lines, biosafety cabinets, rooms, and other enclosed areas.

The VHP process is a dry sterilization process. A single mobile or modular system generates, delivers, controls, and removes hydrogen peroxide vapor for an enclosed environment. During the sterilization phase of the cycle, the system maintains hydrogen peroxide in a dry vapor form to optimize efficacy and continually removes and replenishes vapor concentrations throughout the programmed cycle.