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Devices FDA

 News Release - March 11, 2021

Revolutionary Option for Medical Device Sterilization Approved by FDA

BRANCHBURG, N.J., March 11, 2021 -- (Healthcare Sales & Marketing Network) -- The United States Food and Drug Administration (FDA) newly approved chlorine dioxide gas for contract sterilization of medical devices. This breakthrough advancement for the medical industry was awarded to ClorDiSys Solutions, Inc, headquartered in Branchburg, NJ (registration number 3013115071). This news follows public safety hazards of the industry standard, ethylene oxide. ClorDiSys utilizes chlorine dioxide gas, a non-carcinogenic, United States 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 gamechanger 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. Chlorine dioxide gas sterilization stands to be a major disruptive force in the industry. 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.

Established in 2001, ClorDiSys Solutions, Inc is a New Jersey based business that manufactures sterilization and disinfection equipment and provides decontamination services. ClorDiSys developed its technology through Johnson and Johnson, and chlorine dioxide gas has been providing true sterilization of medical devices for over 25 years on items such as suture products, artificial joints, and implantable contact lenses.

Source: ClorDiSys Solutions

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