The U.S. FDA has newly approved chlorine dioxide gas for contract sterilization of medical devices, and has made ClorDiSys Solutions, Inc, headquartered in Branchburg, N.J., an FDA-registered contract sterilization facility (registration number 3013115071). This news follows reports of the public safety hazards of the industry standard, ethylene oxide. 

ClorDiSys utilizes chlorine dioxide gas, a non-carcinogenic, U.S. Environmental Protection Agency (EPA) registered sterilant. Another advantage of the chlorine dioxide sterilization approach is the ability to sterilize devices containing embedded batteries. Previous methods, such as ethylene oxide, do not allow for the sterilization of such devices due to the explosivity of the gas posing a potential danger when interacting with one another. Chlorine dioxide vacuum pressure sterilizers allow for the option of the sterilization of complex designed devices within bulk packaging. 

The other benefit is the vast reduction in cycle time and complexity of the chlorine dioxide gas sterilization process. Items can be loaded into a single sterilization chamber and the entire cycle, including aeration, occurs inside. Cycles range depending on each device’s requirements, but typically last from two to eight hours, start to finish. 

According to ClorDiSys, chlorine dioxide gas sterilization stands to be a major disruptive force in the industry. The company says the technology provides new opportunities to manufacturers with advanced device technology and introduces a new environmentally friendly means of sterilization to an industry that is decades deep in carcinogenic emissions.