ClorDiSys Solutions officially expanded its presence in Europe for its chlorine dioxide gas technology for medical device sterilization at the PDA Universe of Pre-filled Syringes and Injection Devices Conference in Gothenburg, Sweden.
Since establishing its Pure CD as a primary method for replacing ethylene oxide gas in the US due to ethylene oxide’s health and environmental concerns, it is now further expanding the technology into Europe. Chlorine dioxide gas performs in a near identical manner as that of ethylene oxide, the current industry standard, according to the company. However, chlorine dioxide gas does not share the same safety concerns as ethylene oxide.
ClorDiSys’ chlorine dioxide gas is non-carcinogenic, non-explosive, and is a United States Environmental Protection Agency (EPA) registered sterilant. Chlorine dioxide vacuum pressure sterilizers allow for the sterilization of complex designed devices within bulk packaging, as well as a reduction in cycle time and complexity of the chlorine dioxide gas sterilization process.
Items can be loaded into the sterilization chamber for the entire cycle, including aeration. Cycles range in time depending on each device’s requirements, but typically last from four to eight hours, according to the company. The sterilization process also operates at ambient temperature, which can benefit cold chain products and temperature sensitive materials.
At the PDA conference in Gothenburg, ClorDiSys presented a poster discussing the validation of a cold chain, recombinant protein, pre-filled syringe, which degraded with ethylene oxide sterilization and was unsuitable for alternative sterilization modalities. Chlorine dioxide gas sterilization was the optimal option for this drug, as well as many other devices, because the cycles are shorter than what the necessary ethylene oxide cycle would be, and the temperature within the chamber did not exceed 21 degrees Celsius. Also, the packaging was able to be sterilized as well since cellulose products are compatible with chlorine dioxide gas.
ClorDiSys Solutions is a New Jersey based business that manufactures sterilization and disinfection equipment and provides decontamination services. ClorDiSys developed its technology through Johnson and Johnson.