LANCASTER, Pa. - Eurofins Medical Device Services North America, part of a global network of over 20 medical device testing laboratories and a medical device solutions partner, recently launched a GMP PFAS testing and screening solution, the first developed and commercialized for the medical device industry. This offering provides insights to medical device manufacturers as they navigate the complex and evolving global regulations surrounding PFAS, ultimately contributing to medical device and patient safety.
Per- and polyfluoroalkyl substances, or PFAS, are a group of more than twenty thousand chemical compounds which are highly resistant to degradation and have been found to pose potential threats to human health and the environment. Implementing PFAS testing in the early development stages allows medical device manufacturers to prepare for potential regulatory updates and avoid future shutdowns, recalls, and liability issues, while further supporting their sustainability goals.
Eurofins Medical Device Services North America’s GMP PFAS testing and screening solution includes:
- Combustion Ion Chromatography (CIC) for total organic fluorine screening in solids, liquids, and gases, to provide an initial assessment of PFAS levels.
- Process mapping and supply chain audits, to identify contamination pathways.
- Solvent extraction and direct combustion for flexible sample formats.
- Extractables & Leachables (E&L) testing, toxicological risk assessments, and aging studies.
- Stability and forced degradation studies, to identify PFAS breakdown products.
Eurofins Medical Device Services North America operates under ISO 17025 accreditation standards, and applies GMP best practices, ensuring sensitivity, specificity, and reproducibility even at trace levels.
