ClorDiSys Solutions, Inc ISO 13485 Certification

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Sep 22, 2021, 14:00 ET

BRANCHBURG, N.J., Sept. 22, 2021 /PRNewswire/ -- ClorDiSys Solutions, Inc is pleased to announce that its Quality Management System is ISO 13485 certified for both the design and manufacture of decontamination and sterilization equipment as well as the performance of decontamination and sterilization services. ClorDiSys' proprietary method of the producing chlorine dioxide gas yields a non-carcinogenic, US EPA registered sterilant. The technology has been used for the sterilization of medical devices for over 25 years, however the prevalence of medical devices being sterilized with chlorine dioxide has significantly increased alongside greater concern over environmental impacts of ethylene oxide sterilization. ClorDiSys has FDA registration (registration number 3013115071) to perform contract sterilization of medical devices, but also develops devices to allow firms to take this task on themselves. The Steridox chlorine dioxide sterilizers can be added to any manufacturing space in a simple and affordable manner. This is due to the non-explosive nature of chlorine dioxide gas, which eliminates the need for protective structures or intrinsically safe wiring as Ethylene Oxide sterilizers require. ClorDiSys' chlorine dioxide vacuum pressure sterilizers allow for the sterilization of complex designed medical devices, even those with embedded batteries or in bulk packaging. The other advantage is the vast reduction in cycle time and complexity of the sterilization process. Items can be loaded into a single chamber where the entire cycle, including aeration, occurs. The overall goal of the organization is to provide effective and safe methods of sterilization in the highest of quality. Sterilizations are able to be monitored throughout the process and the chambers can ensure repeatability and consistent results of a sterilized product ready for market without any damaging environmental effects.

Established in 2001, ClorDiSys Solutions, Inc is a New Jersey based business manufacturing sterilization and disinfection equipment and providing 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.

SOURCE ClorDiSys Solutions Inc