In response to the U.S. Environmental Protection Agency's final ruling on ethylene oxide commercial sterilization, which has raised concerns among medical device developers, Boulder iQ is taking proactive measures to expand its chlorine dioxide sterilization capacity. The company, through its Boulder Sterilization division, aims to provide an effective and environmentally friendly alternative to EO sterilization, ensuring that medical device developers can continue to bring their products to market efficiently.
The EPA's final rule, issued in April, puts in place the strongest measures to date for EO commercial sterilization facilities. This ruling is expected to impact virtually all medical device contract sterilization companies and has the potential to significantly decrease the supply of EO sterilization facilities while increasing EO sterilization prices. As a result, medical device developers who have traditionally relied on EO sterilization are now seeking alternative solutions.
Recognizing the growing demand for CD sterilization, Boulder Sterilization has converted another one of its EO chambers to CD. This smaller, 8-cubic-foot chamber complements the company's existing 270-cubic-foot CD sterilizer, providing greater flexibility and capacity to meet the diverse needs of medical device developers. Jim Kasic, president and CEO of Boulder iQ, notes, "Once they understand the benefits of CD sterilization, they are anxious to make the move."
Chlorine dioxide offers numerous advantages as a sterilization method. It is an effective, efficient, and clean alternative with a long and successful history. CD is non-carcinogenic, nonflammable, and leaves no post-treatment residuals, making it an environmentally friendly option suitable for a majority of medical devices. Additionally, CD can sterilize at room temperature, making it ideal for novel materials and plastics.
While Boulder Sterilization is expanding its CD sterilization capacity, the company will continue to operate six small EO chambers, acknowledging that EO will still be the best sterilization choice for some products. To ensure safety and compliance with the new EPA standards, Boulder Sterilization uses small, single-use EO canisters that provide simple, safe loading and unloading, eliminating the risks associated with handling large quantities of potentially dangerous EO gas. Furthermore, the company has equipped its EO sterilizers with abators, catalytic converters, that reduce emissions by more than 99.9%, already meeting the new EPA standards.
The variety of CD chamber sizes offered by Boulder Sterilization allows the company to meet the market need for different volumes and sizes of products. Coupled with their fast-turn service, which can complete standard validations in as little as four weeks, Boulder iQ is well-positioned to help medical device developers bring their products to market faster and more efficiently, regardless of the type of sterilization that works best for them.
As the medical device industry navigates the challenges posed by the EPA's final ruling on EO commercial sterilization, Boulder iQ's proactive approach to expanding its CD sterilization capacity demonstrates the company's commitment to providing innovative solutions that address the evolving needs of medical device developers. By offering a range of sterilization options, including both CD and EO, Boulder iQ ensures that its clients can continue to bring their products to market efficiently and effectively, while also prioritizing environmental sustainability and compliance with regulatory standards.
