Chlorine Dioxide Gas added into AAMI TIR 17

BRANCHBURG, N.J., Jan. 23, 2025 /PRNewswire/ -- The Association for the Advancement of Medical Instrumentation (AAMI) recently released the Technical Information Report (TIR) 17, Compatibility of Materials Subject to Sterilization. This newest edition of TIR 17 now incorporates chlorine dioxide gas and its impact on materials after processing. ClorDiSys, headquartered in Branchburg, New Jersey, heavily contributed to this section and provided testing results, studies, and peer reviewed papers to offer a scientifically backed rating for materials treated with chlorine dioxide gas.  

Currently the United State Dood and Drug Administration (FDA) is seeking alternative sterilization methods from both ethylene oxide and Gamma irradiation due to their environmental risks. Chlorine dioxide gas sterilization is indeed the closest alternative to ethylene oxide, with significant advancements as well.  It is non-carcinogenic, non-explosive, and lacks harmful residuals. A key point is that chlorine dioxide is a true gas, meaning that it will penetrate tight areas and fill a chamber completely and evenly, rather than condense onto surfaces or limit penetration as a vapor would.  Unlike other low temperature sterilization methods, chlorine dioxide can also successfully sterilize cellulosic materials.  Since it is non-explosive at use concentrations, chlorine dioxide can sterilize embedded batteries, whereas ethylene oxide causes many restrictions to advanced technology that features these.

ClorDiSys' chlorine dioxide gas generation method was developed by Johnson and Johnson and produces a non-acidic gas that is gentle on materials and is an EPA registered sterilant. This generation method greatly contributes to the high material compatibility generally reflected in TIR 17 and differs from other some other methods of generation. ClorDiSys is an FDA registered contract sterilization facility, but also manufactures sterilization chambers, allowing for sterilization to be brought in-house. Cycles frequently are 1/10^th of the time that an equivalent ethylene oxide cycle would take, and if processing is performed in-house, the supply chain can even be further reduced. 

Established in 2001, ClorDiSys is a New Jersey based business manufacturing sterilization 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.

Media Contact: Emily Lorcheim, ClorDiSys, Phone: 908-236-4100, [email protected], 50 Tannery Rd, Suite 1, Branchburg, NJ 08876

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SOURCE ClorDiSys Solutions Inc