The Boulder iQ site is increasing the ability to sterilize medical devices with chlorine dioxide

In April, the U.S. Environmental Protection Agency (EPA) issued a final rule that will introduce the strictest measures yet for commercial sterilization facilities (EO) – a rule that will impact virtually all contract medical device sterilization companies and which could significantly reduce the supply of devices for EO sterilization and increase the prices of EO sterilization.

An alternative to chlorine dioxide
“Medical device developers accustomed to EO sterilization are understandably concerned about its feasibility and future availability,” Kasic says. While the EPA is not eliminating EO sterilization, but rather working to reduce EO exposure, it states that CD represents one of the best alternatives available. “It is an effective, efficient and clean sterilization method with a long and successful history,” he explains.

The CD is also an environmentally friendly option, suitable for most medical devices. It is not carcinogenic, non-flammable and does not leave any residues after processing. It can sterilize at room temperature, making it ideal for novel materials and plastics.

Safe EO sterilization
Boulder Sterilization will continue to operate six small EO chambers. “EO will still be the best choice for sterilization for some products,” Kasic says. The company uses small, disposable EO canisters to ensure simple and safe loading and unloading, eliminating the risks associated with large volumes of potentially hazardous-to-handle EO gas. The contract sterilization organization has also equipped its EO sterilizers with abators (catalysts) that reduce emissions by over 99.9%, already in accordance with the new EPA standards.

“The options we offer and the variety of CD chamber sizes allow us to meet market demand for products of various volumes and sizes,” says Kasic. “With our rapid service – completing standard validations in just four weeks – we can help medical device developers bring products to market faster and more efficiently than ever, with whichever type of sterilization is best for them.”

Pebble iQ (http://www.boulderiq.com)
Pebble iQ is a contract company that provides life sciences companies with all the services they need to bring their products to market. By specializing in regulatory affairs, quality assurance, design, engineering and manufacturing, the company’s single-source program accelerates product development. The Boulder Sterilization Department provides rapid ethylene oxide and chlorine dioxide sterilization, final assembly and packaging services. Based on Boulder, Colorado, Pebble iQ is ISO 13485:2016 certified by Boulder BioMed.

Contact with the media

Aimee BennettFagan’s Business Communications, 3038439840, (email protected)

SOURCE Pebble intelligence quotient