Dive Brief:

• Boulder Sterilization is introducing contract chlorine dioxide sterilization services this summer to provide medical device manufacturers with an alternative to ethylene oxide (EtO).
• The rollout of the service will make Boulder Sterilization, a division of Boulder iQ, part of a small group of companies to offer medtech sterilization using the gas and, it claims, the only provider to offer both EtO and chlorine dioxide services.
• Boulder Sterilization’s addition of chlorine dioxide capabilities comes as the industry races to find alternatives to EtO ahead of restrictions on the use of the carcinogenic gas.

Dive Insight:

Interest in using chlorine dioxide to sterilize medical devices dates back decades. A patent filed in 1982 described the use of chlorine dioxide to “sterilize surfaces, especially the gas impermeable surfaces of implements commonly employed in the medical sciences.” Yet, while some sterilization companies such as ClorDiSys Solutions have deployed the approach, EtO has remained the standard for many devices. 

EtO’s role in the industry is threatened by U.S. Environmental Protection Agency proposals to place new limits on emissions of the gas. Industry groups have warned the proposals could cause device shortages, and the U.S. Food and Drug Administration is working to help manufacturers switch to other methods. 

While the FDA’s program focuses on switching to x-ray or electron beam radiation, Boulder Sterilization is adding chlorine dioxide sterilization services to provide manufacturers with another option. In a statement, Jim Kasic, chairman and founder of Boulder Sterilization, framed the introduction as a response to the market moving “increasingly toward safer ‘green’ options of sterilization.”

Boulder Sterilization’s expansion will see it join ClorDiSys, which registered its site with the FDA late in 2020, on the list of companies to offer contract chlorine dioxide sterilization services. To offer the new service, Boulder Sterilization has added what it claims is the largest contract chlorine dioxide sterilization chamber in the world. The chamber supports “batches and products of almost any size,” the company said.