Managing PFAS In Pharmaceutical Manufacturing: A Risk Management Approach For The Pharmaceutical Industry

A single swap, say a fluoropolymer gasket or filter, can force requalification, validation and refiling. Fluorine sits in a meaningful share of APIs, and fluoropolymers run through tubing, stoppers, seals and delivery devices. Many of these uses are treated as essential for now.

This paper traces where polymer and small-molecule PFAS enter the lifecycle, from R&D to patient use, and why the distinction matters to regulators. It also looks at four pressures that make PFAS a present-tense business issue, including a narrowing supplier base. Methods and abatement tools built for long-chain PFAS in groundwater often fit pharmaceutical wastewater poorly. The authors propose a phased framework to close that gap.

Read the phased framework.