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Clordisys Solutions announced the publication of a peer-reviewed study in Journal of Medical and Biological Engineering that supports chlorine dioxide gas sterilization as a viable, non-toxic alternative to ethylene oxide for medical device manufacturers and contract sterilizers.
The company’s chlorine dioxide gas is non-carcinogenic, non-explosive, and a United States Environmental Protection Agency (EPA)–registered sterilant. Chlorine dioxide vacuum pressure sterilizers enable the sterilization of complex device designs within bulk packaging, while also offering a substantial reduction in cycle time and overall process complexity. Devices can be loaded directly into the sterilization chamber, and the complete cycle — including aeration — typically occurs within 4 to 8 hours.
During the sterilization process, chlorine dioxide gas breaks down into benign by-products, chlorite, chlorate, and chloride, which are generally present at non-detectable levels. Publication of this study provides important guidance to manufacturers on validation approaches when utilizing chlorine dioxide gas, particularly with respect to evaluating and managing potential residual levels. Chlorine dioxide provides a much safer approach for a sterilization modality in terms of residuals as compared to alternative modalities such as ethylene oxide.
Clordisys is an FDA-registered contract sterilization provider (registration number 3013115071) and offers both sterilization and validation services. Chlorine dioxide gas sterilization has the potential to significantly advance the medical device industry by expanding manufacturing options and introducing an environmentally friendly sterilization modality to both the medical device and pharmaceutical sectors.
SOURCE: ClorDiSys Solutions, Inc.
