ClorDiSys Study Supports Chlorine Dioxide for Cold-Chain Sterilization

BRANCHBURG, N.J., Sept. 22, 2026 /CourierPR/ -- A new peer-reviewed study published in PLOS ONE has demonstrated the capabilities of chlorine dioxide (ClO₂) gas sterilization as an ideal terminal sterilization option for temperature-sensitive pharmaceutical, medical device, and combination products.

Cold-chain products are often challenging to sterilize because traditional modalities such as ethylene oxide (EO) may expose products to temperatures that can compromise sensitive materials or drug formulations. EO sterilization involves elevated temperatures and substantially longer processing times, including heated aeration, increasing the time products spend outside their controlled cold-chain conditions. This prolonged exposure can be particularly problematic for medical devices or combination products containing drug products, which cannot off-gas and residual levels of EO can exceed allowable levels, potentially destroying a drug product's integrity if EO ingresses into the drug itself.

By comparison, the validated chlorine dioxide cycle evaluated in the study was performed at ambient temperature, maintaining the product below 21°C. The average cycle lasted approximately three hours and 45 minutes, including preconditioning and aeration. These conditions maintained the integrity of the drug and, as an additional benefit, the cycle was a tenth of the time that the EO cycle for the product would be, making the chlorine dioxide gas process much more efficient for a supply chain.

The researchers also reported no evidence of ingress into the syringe contents under the conditions tested. The findings support chlorine dioxide as an ideal alternative sterilization modality for pharmaceutical and medical device manufacturers whose products require cold-chain handling.

Clordisys, a New Jersey-based contract sterilization facility and manufacturer of sterilization equipment and consumables, has developed its chlorine dioxide technology through Johnson & Johnson. The company has been using chlorine dioxide gas for true sterilization of medical devices for over 25 years.