Eurofins Medical Device Testing expands Extractables & Leachables capabilities in Germany

Katrin Witschital, PhD, Head of Analytics, Eurofins Medical Device Testing Munich, KatrinWitschital@eurofins.com

The first step in conducting the biological evaluation of medical devices, as defined in the ISO 10993 standard series, is chemical characterisation. Eurofins Medical Device Testing, an industry leader in this area, with over 50 scientists in its global Extractables and Leachables (E&L) team, is strengthening its capabilities at its site in Munich, Germany.

An accurate chemical characterisation study can save companies time and money when assessing the biological safety of their medical devices. A thorough toxicological risk assessment of the results generated by an E&L study can reduce the need for subsequent in vivo tests when evaluating:

• New device or packaging designs
• Changes in raw materials suppliers
• Changes in manufacturing processes

For medical devices in direct or indirect contact with body tissues or fluids, ISO 10993-12 states that solvents of different polarity should be used. Therefore, we use a variety of extraction solvents for simulated use or exaggerated extractions for semi-volatile compounds before GC-MS/FID fingerprint analytics:

• Standard solvents: water, 0.9% saline solution, 5% ethanol in water, isopropanol and n-hexane
• Artificial body fluids, e.g. artificial sweat, gastric juice, urine or saliva
• Customised solvents as dictated by use, e.g. 20-50% ethanol in water, methyl methacrylate

Our specialists have extensive knowledge and expertise to plan and coordinate your studies. Our detailed reports have been used to support many successful regulatory submissions, around the world.

No matter how complex the construction of your medical device, or how exotic the material, our experts will find a way to prepare, extract and analyze it in full compliance with ISO 10933 Parts 12 and 18.

In addition to the GC-fingerprint analysis for semi-volatile organic compounds, Eurofins Medical Device Testing is currently increasing its analytical testing capacity in Munich with the addition of three new analytical techniques at that laboratory:

• Headspace GC/MS-FID for volatile organic compounds
• LC/MS (Q-TOF) for non-volatile organic compounds
• ICP/MS for elements and metals analysis

Eurofins Medical Device Testing’s laboratory in Munich operates in compliance with GLP quality systems, and has been accredited to ISO 17025 for biocompatibility testing of medical devices. For 30 years, the team in Munich has been helping medical device companies bring a wide range of products to market.

For more information visit: www.Eurofins.com/Medical-Device