Eurofins Medical Device Services is setting new standards with breakthrough GMP PFAS testing and advanced PFAS risk assessments for medical devices.
PFAS testing and screening solutions were first developed and commercialized for the medical device industry.
This provides insight for medical device manufacturers as they navigate the complex and evolving global regulations surrounding PFAS, ultimately contributing to medical device and patient safety.
Importance of PFAS testing for medical devices
Per- and polyfluoroalkyl substances (PFAS) are a group of more than 20,000 compounds that are highly resistant to degradation and have been found to pose potential threats to human health and the environment.
Whether intentionally added to medical devices or introduced during manufacturing, this compound is not easily degraded, raising concerns about long-term health and environmental risks.
By performing PFAS testing early in development, medical device manufacturers can prepare for potential regulatory updates and avoid future outages, recalls, and liability issues, while further supporting sustainability goals.
Eurofins Medical Device Services provides comprehensive testing, consulting, and regulatory support for Class I, II, and III medical devices, including implants, devices, disposable and combination products, and wearables.
Features of new testing and screening solutions
Eurofins Medical Device Services’ GMP PFAS testing and screening solutions include:
Combustion ion chromatography (CIC) screens for total organic fluorine in solids, liquids, and gases to provide an initial assessment of PFAS levels. Process mapping and supply chain audits to identify contamination routes. Solvent extraction and direct combustion for flexible sample formats. Extractables & Leachables (E&L) testing, toxicological risk assessment, and aging research. Stability and forced degradation studies to identify PFAS degradation products.
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