Navigating Emerging Contaminant: PFAS - Sources, Regulations, Detection and Mitigation
Information
PFAS are a large family of synthetic chemicals highly resistant to heat, water, and chemical breakdown. They can accumulate in the environment and living organisms, raising health and regulatory concerns. They are widely used across industries—including pharmaceuticals, where they appear in fluorinated APIs, process equipment, packaging, analytical instruments and process wastewater.
In the U.S., the EPA is tightening controls on PFAS through its PFAS Strategic Roadmap, including drinking water limits, wastewater discharge standards. In the EU, REACH has proposed one of the broadest chemical restrictions ever, aiming to ban or phase out most PFAS.
Pharma companies are engaging regulators to seek exemptions for critical medicinal uses under EU REACH, while at the same time exploring safer alternatives, improved waste management, and greener chemistries to limit environmental release.
Pharmaceutical companies also face significant challenges in PFAS detection and compliance due to extremely low levels (1-100 ppt for example) and the diversity of PFAS compounds. The combination of ultra-trace levels, variable limits, and complex matrices makes PFAS monitoring and compliance particularly challenging for the pharmaceutical industry.
