Eurofins Medical Device Services US offers expert guidance and quick turnaround times for small-scale ethylene oxide sterilization needs

John Hodges, Senior Business Development Director, Eurofins BioPharma Product Testing

Regularly audited by the FDA and fully cGMP compliant, Eurofins Medical Device Services’ San Jose, CA, Ethylene Oxide (EO) Sterilization site provides high-quality, fast turnaround contract sterilization and validation services for the medical device industry. Specializing in servicing small-scale sterilization projects, and adhering to ISO 11135 and CFR 820, the site operates seven 3M™ Steri-Vac™ GS8X pure EO sterilizers to ensure the elimination of microbial risks for medical devices and their components.

With EO exposure, the preferred modality to sterilize more than 50 percent of medical devices on the market, Eurofins’ San Jose site provides the necessary support to meet high market demand. The site’s sterilizers have a maximum sterilization capacity of 8 cubic feet to service a unique niche of medical device sterilization needs. Noted for quick turnaround times, our experts routinely process R&D and production sterilization requests in days and turn around full sterilization validations in weeks.

Eurofins Medical Device Services’ experts work with manufacturers to devise robust sterilization plans to address potential concerns with unique and potentially temperature-sensitive devices. This is important as the biggest hurdle to overcome in a typical EO sterilization run is the required use of higher temperatures and humidity. To meet this challenge, we often performs small R&D testing runs on a small number of devices to test the impact of the conditions before moving to runs with larger batches of devices.

Eurofins’ EO sterilization experts work within the new EPA regulations to ensure that more than 99 percent of EO gas used during sterilization is removed from any air passing in and out of the lab.