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Chlorine Dioxide Medical Device Sterilization: Residual Toxicity Testing
December 2, 2025
Ethylene oxide (EtO), a commonly used sterilant for medical devices, is a known carcinogen that leaves carcino- genic residuals. Recent regulatory changes encourage medical device manufacturers to consider non-carcinogenic sterilants, including chlorine dioxide (ClO2) sterilization.
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Compatibility of Materials Subject to Chlorine Dioxide Gas Sterilization
July 1, 2023
Chlorine dioxide gas is an oxidating agent. Oxidizers remove hydrogen atoms through the addition of oxygen. While this process may result in no material changes, a difference in material weight could be detrimental to the final product. To determine the compatibility of materials with Chlorine dioxide gas sterilization, two studies were completed.
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Bacterial Endotoxins
April 22, 2021
Since its introduction, the Limulus Amebocyte Lysate (LAL test) has become one of the most important tools used in the pharmaceutical industry. It has allowed for a level of bacteria and pyrogen monitoring that simply eluded manufacturers when the RPT was the only pyrogen test available.
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Lyophilizer Sterilization
April 1, 2019
A lyophilizer (lyo) is typically decontaminated on a periodic basis and usually after each production batch. The typical process is to decontaminate by using steam to raise the temperature and hold it there until 6-log kill is attained.
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ß-Lactam Inactivation Utilizing Chlorine Dioxide Gas
April 1, 2019
Chlorine dioxide gas is proven effective against ß-lactams(beta-lactams) and can inactive them on equipment or in rooms so that there is no risk of allergic exposure. ClO2, as a true gas, will reach all areas of your room and equipment surfaces.
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Effect of ClO2 sterilization on chemical and functional properties of elastomeric closures
November 28, 2018
Next to sterilization with steam, ionizing radiation and ethylene oxide, ClO2 can also be used to sterilize elastomeric closures. To verify whether this is a viable option, the effect of ClO2 exposure on the chemical and functional properties of different Datwyler 20mm stoppers was investigated.
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Chlorine Dioxide Gas Penetration Examples
December 1, 2016
Clorine Dioxide gas gets thorough distribution and penetration which is key for any decontamination to be effective. To test this, challenging studies were performed with various equipment, materials and loads.
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