In response to a shortage of safe, effective sterilization services used in the development of medical devices, Boulder iQ expanded its operation and is now offering ethylene oxide sterilization services through its Sterilization division in Boulder, Colorado.
Boulder iQ is a contract consulting firm offering design engineering, development, and turnkey manufacturing for consumer, high-technology and medical products, and regulatory, clinical and quality compliance services for medical device and in vitro diagnostic companies. The company is ISO 13485:2016 certified through Boulder BioMed.
According to company officials, ethylene oxide sterilization is a safe, effective low-temperature method for sterilization, says Jim Kasic, president and CEO of Boulder iQ. Boulder Sterilization employs the 3M Steri-Vac Sterilizer/Aerator 8XL Series, designed for medical device sterilization, contract sterilization, research and development laboratory applications, and other research and industrial applications requiring terminal sterilization.
The company will use an abator (catalytic converter) system to mitigate outgassing that is inherent in the EO process. While not required in Colorado, Boulder iQ has opted to incorporate the abator to underscore its commitment to green operations.
“The introduction of Boulder iQ’s services will have a significant impact on the medical device industry,” says Kasic. With the closure of several EO sterilization facilities across the country over the past year, queues for companies trying to bring new medical devices to market can be six or more months, he explains.
“That is a prohibitively long time for a business trying to launch an important new product. Boulder iQ’s EO sterilization service will provide a path for these companies to get innovative products to market quickly,” he added.
Along with providing short lead times for sterilization, Kasic says, Boulder Sterilization is offering sterile packaging. The company can seal Tyvek pouches, common sterile packaging for medical devices. Boulder Sterilization said it will also offer a streamlined online ordering process to customers once they have completed a sterilization validation with the company. “By helping manufacturers get their products to market faster and more efficiently, we can help prevent medical device shortages, and in so doing, ultimately impact patient lives in a meaningful way.