The Hidden Chemicals in Your Manufacturing Process Where PFAS actually come from — and why pharma needs to pay attention

Published: May 2026   |   Author: Sandi Schaible 

"Forever chemicals" have become one of the defining regulatory stories of the decade. Per- and polyfluoroalkyl substances — PFAS — are synthetic chemicals that do not break down in the environment or the human body. They have been found in drinking water, soil, fish, and the blood of people around the world. Regulators in the US, Europe, and beyond are setting ever-stricter limits, and industries that have relied on these materials for decades are being asked hard questions. If you work in pharmaceutical or biopharmaceutical manufacturing, the question is not whether this is your problem too — it is. The question is exactly where in your operations these chemicals appear, and what that means for your products and your patients.

PTFE — the same non-stick material used in cookware — is one of the most widely used materials in pharmaceutical manufacturing. It is chemically resistant, easy to sterilize, and does not react with the drugs or biological fluids it contacts. Those properties make it invaluable. You will find it lining the filters used to sterilize your drug product before filling, coating the plunger tips of prefilled syringes, forming the membranes used to purify biological drugs, and sealing the valves and pumps that move your product through the manufacturing line. In biopharmaceutical manufacturing in particular, a related material called PVDF (polyvinylidene fluoride) is the membrane of choice for many filtration steps. Both materials are essential, widely trusted, and not going away.

But here is the part of the story that is less well known. To manufacture fluoropolymers like PTFE and PVDF in the first place, chemical companies use processing agents — specialized chemicals that help the polymerization reaction work. For decades, the primary processing agent was PFOA, a compound now classified as a probable human carcinogen. PFOA was phased out by 2016. The replacement most widely used since then is called GenX. Neither of these chemicals disappears completely during manufacturing. Tiny residual amounts remain in the finished material — and because they are small molecules rather than part of the solid plastic, they are capable of migrating out of the material and into whatever liquid they are in contact with. In a pharmaceutical context, that liquid is often your drug product (leachables).

There is an additional complication specific to biopharmaceutical manufacturing: the rise of single-use systems. In the last fifteen years, the industry has moved heavily toward disposable bioreactors, tubing, connectors, and filtration assemblies rather than reusable stainless steel equipment. The fluid-contact surfaces of these systems are typically made from multi-layer plastic films and membranes — many of which contain PTFE, PVDF, or related materials. These disposable components are in prolonged, intimate contact with your cell culture, your purified protein, or your viral vector — and the extractables from those components go directly into your drug substance.

The point of this blog is not to alarm you — it is to reframe the question. PFAS in pharmaceutical manufacturing is not a fringe concern or a future problem. It is present today, in materials your teams work with every day, and regulators are already beginning to ask questions about it. The good news is that there are practical steps to understand and manage it. The rest of this series walks through exactly what those steps are.

 About Bonded in Science

Bonded in Science, LLC provides independent Scientific Consulting and Strategy for the Life Science Industry. I help companies navigate complex chemical safety questions — including PFAS — in plain language that makes sense for your whole team. Visit us at www.bondedinscience.com.

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