Eurofins Medical Device Services is setting new standards with groundbreaking GMP PFAS testing and advanced PFAS risk assessments for medical devices.
The PFAS testing and screening solutions are the first developed and commercialised for the medical device industry.
It will provide insights to medical device manufacturers as they navigate the complex and evolving global regulations surrounding PFAS, ultimately contributing to medical device and patient safety.
The importance of PFAS testing for medical devices
Per- and polyfluoroalkyl substances (PFAS) are a group of more than 20,000 chemical compounds which are highly resistant to degradation and have been found to pose potential threats to human health and the environment.
Whether purposely added to a medical device or introduced during manufacturing, the compounds’ inability to break down easily raises concerns about long-term health and environmental risks.
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 offers comprehensive testing, consulting, and regulatory support for Class I, II, and III medical devices – including implants, instruments, single-use and combination products, and wearables.
Features of the new testing and screening solutions
Eurofins Medical Device Services’ 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.
