If you’re facing limited internal testing capabilities, unsure which sterilization modality or regulatory path to follow, or wish to avoid the cost and delays caused by repeated testing, you need an expert partner. Eurofins Medical Device Services network of laboratories offers fully cGMP-compliant and FDA-audited facilities, providing you with complete solutions for sterility and sterilization validations, combining expert knowledge, advanced instrumentation, and rapid turnaround.

At our ethylene oxide (EO) sterilization site in San Jose, CA, we operate seven 3M® GS8X pure EO sterilizers which are ideal for small-scale sterilization projects. This unique capacity allows us to process R&D batches with quick turnaround times, performing full validations in weeks rather than months, so you can keep pace with your development schedule. 

We specialize in both established and novel sterilization modalities, including:

• Ethylene Oxide (EtO) – ISO 11135 and CFR 820 compliant, ideal for temperature-sensitive products.
• Radiation – Gamma, E-BEAM, and X-ray, guided by ISO 11137 series, with robust support for VDMax and dose audit testing.
• Novel modalities – Vaporized peracetic acid, high intensity light or pulse light, microwave radiation, sound waves, ultraviolet light, and nitrogen dioxide (NO2) under ISO 14937, for devices where traditional methods may not apply.

To meet your specific needs, our scientists carry out small R&D sterilization runs to evaluate temperature and humidity impacts, minimizing product risk ahead of full-scale validation. We also ensure that >99% of EO gas used is treated, in full alignment with EPA regulations. 

In addition to sterilization services, our team works closely with your engineers to develop robust sterilization plans and process challenge devices (PCDs), ensuring regulatory acceptance and reducing the risk of costly setbacks. As well as support for both single-use and reusable devices.

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