Regularly audited by the FDA and fully cGMP compliant, Eurofins Medical Device Services’ newly acquired San Jose, CA, Ethylene Oxide (EO) Sterilisation site provides high-quality, fast turnaround contract sterilisation and validation services for the medical device industry. Specialising in servicing small-scale sterilisation projects, and adhering to ISO 11135 and CFR 820, the site operates seven 3M GS8X pure EO sterilisers to ensure the elimination of microbial risks for medical devices and their components.
With EO exposure, the preferred modality to sterilise more than 50% of medical devices on the market, Eurofins’ San Jose site provides the necessary support to meet high market demand. The site’s sterilisers have a maximum sterilisation capacity of 8 cubic feet to service a unique niche of medical device sterilisation needs. Noted for quick turnaround times, our experts routinely process R&D and production sterilisation requests in days and turn around full sterilisation validations in weeks.
Eurofins Medical Device Services’ experts work with manufacturers to devise robust sterilisation 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 sterilisation run is the required use of higher temperatures and humidity. To meet this challenge, Eurofins’ team 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 Sterilisation experts work within the new EPA regulations to ensure that more than 99% of EO gas used during sterilisation is removed from any air passing in and out of the lab. For more information, contact: medical-device@bpt.eurofinsus.com