Eurofins Medical Device Services Expands US Portfolio With New Ethylene Oxide Sterilisation Solution

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. Fully cGMP compliant and regularly audited by the FDA, the site specializes in small-scale sterilization projects, adhering to ISO 11135 and CRF 820 standards. It operates seven 3M GS8X pure EO sterilizers, each with an 8-cubic-foot capacity, ensuring effective microbial elimination for medical devices and components.

EO sterilization is the preferred method for over 50% of medical devices due to its effectiveness. Eurofins’ San Jose facility meets this demand by offering rapid processing of R&D and production sterilization requests within days and full sterilization validations within weeks. Their experts collaborate with manufacturers to develop customized sterilization plans, addressing challenges such as temperature and humidity sensitivity in delicate medical devices. Small R&D test runs help evaluate these effects before larger batch sterilization.

In compliance with new EPA regulations, Eurofins ensures that over 99% of EO gas used during sterilization is removed from any air entering or leaving the lab, prioritizing safety and environmental responsibility. This comprehensive approach allows Eurofins to provide efficient, regulatory-compliant sterilization solutions while maintaining industry-leading turnaround times and quality standards.