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

The study, “Chlorine dioxide gas sterilization of cold-chain or temperature-sensitive devices,” documents the success of chlorine dioxide processing of cold chain prefilled syringes, including testing for sterilization efficacy, residual sterilant, and potential ingress into the syringe and its contents.

Cold-chain products can be 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 temperature sensitive products spend outside their controlled cold-chain conditions.

EO sterilization can also leave harmful residuals which require off gassing to reduce levels. However, concerns are particularly relevant when medical devices or combination products containing drug products cannot off-gas and residual levels exceed allowable levels, or destroy 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.

Established in 2001, Clordisys is a New Jersey–based contract sterilization facility and a manufacturer of sterilization equipment and consumables. The company developed its chlorine dioxide technology through Johnson & Johnson, and chlorine dioxide gas has been used to achieve true sterilization of medical devices for more than 25 years.

Contact:
Emily Lorcheim
Clordisys Solutions, LLC.
Phone: 1-551-237-8018
Email: emilylorcheim@clordisys.com 
50 Tannery Road, Suite 1
Branchburg, NJ 08876

View original content to download multimedia:https://www.prnewswire.com/news-releases/peer-reviewed-study-demonstrates-chlorine-dioxide-gas-for-cold-chain-product-sterilization-302886376.html

SOURCE ClorDiSys Solutions Inc