Branchburg, New Jersey, U.S., September 22, 2026
ClorDiSys Solutions Inc. has announced the publication of a peer-reviewed study in PLOS ONE demonstrating the potential of chlorine dioxide (ClO₂) gas sterilization as a terminal sterilization option for temperature-sensitive pharmaceutical, medical device and combination products. The study, titled “Chlorine dioxide gas sterilization of cold-chain or temperature-sensitive devices,” evaluated the technology using cold-chain prefilled syringes, examining sterilization effectiveness, residual sterilant levels and whether chlorine dioxide could enter the syringe or its contents during processing. The findings highlight a potential alternative for manufacturers developing and producing products that require controlled temperature conditions throughout the supply chain.
Chlorine Dioxide Addresses Cold-Chain Challenges
Temperature-sensitive pharmaceutical products can present significant challenges during terminal sterilization because conventional sterilization approaches may expose products to conditions that can affect drug formulations, materials or product integrity. The ClorDiSys study specifically examined chlorine dioxide gas as a method that can operate at ambient temperature, potentially providing an alternative for products that cannot tolerate conventional thermal or extended sterilization conditions. According to the published study described by ClorDiSys, the validated chlorine dioxide cycle was conducted while maintaining the product at below 21°C. The complete cycle, including preconditioning and aeration, averaged approximately three hours and 45 minutes. ClorDiSys reported that these processing conditions maintained the integrity of the drug product while requiring substantially less time than the ethylene oxide cycle used for the product evaluated in the study.
The findings are particularly relevant to cold-chain pharmaceuticals and combination products, where sterilization must be carefully balanced against the need to preserve drug quality. Maintaining controlled temperatures during processing can be important for products containing temperature-sensitive active pharmaceutical ingredients, biologics or other formulations whose characteristics could be affected by heat or prolonged processing.
Study Evaluates Prefilled Syringe Sterilization
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The peer-reviewed research focused on cold-chain prefilled syringes, assessing both the effectiveness of sterilization and potential interactions between the sterilization process and the drug-containing product. Researchers also investigated residual sterilant and potential ingress into syringe contents, two important considerations when evaluating a sterilization method for pharmaceutical and combination products. ClorDiSys reported that the study found no evidence of chlorine dioxide ingress into the syringe contents under the tested conditions. The company also stated that the evaluated cycle achieved the required sterilization performance while maintaining product integrity. These findings are important because sterilization technologies for drug-containing devices must address both microbial control and the preservation of the pharmaceutical formulation.
Traditional ethylene oxide (EO) sterilization can involve elevated temperatures, extended processing and aeration requirements. For some temperature-sensitive products, prolonged exposure outside controlled cold-chain conditions can create manufacturing and logistics challenges. EO residuals can also require additional aeration, while combination products containing pharmaceutical formulations may require careful evaluation of potential interactions between the sterilant and drug product.
Potential Impact on Pharmaceutical Manufacturing
The study could have implications for manufacturers developing temperature-sensitive drugs, prefilled syringes, medical devices and combination products. A sterilization process capable of operating at ambient temperature and completing processing in a comparatively short cycle could potentially simplify aspects of manufacturing and supply-chain management for products requiring strict temperature control. ClorDiSys, headquartered in Branchburg, New Jersey, develops chlorine dioxide sterilization technology and provides contract sterilization services, equipment and consumables. The company said its chlorine dioxide technology was developed through Johnson & Johnson and that chlorine dioxide gas has been used for true sterilization of medical devices for more than 25 years.
For the pharmaceutical industry, the research underscores the importance of developing sterilization technologies tailored to modern temperature-sensitive products. As pharmaceutical pipelines increasingly include biologics, advanced formulations and combination products, manufacturers must consider sterilization methods that can provide microbial control without compromising product quality. The PLOS ONE publication provides peer-reviewed evidence supporting further evaluation of chlorine dioxide gas sterilization for cold-chain products. However, the results described in the study apply to the tested conditions and product configuration, and manufacturers would still need to conduct appropriate validation and regulatory assessments for individual products and processes. The research nevertheless highlights an important area of pharmaceutical manufac turing innovation. By combining low-temperature processing, sterilization efficacy and cold-chain compatibility, chlorine dioxide gas could provide another option for manufacturers seeking to address the technical challenges associated with sterilizing sensitive pharmaceutical and combination products.
Source: ClorDiSys Solutions press release
