Regulatory readiness: Building PFAS risk roadmaps in pharma

Understand where PFAS may exist across operations

In pharmaceutical operations, PFAS can show up in places that may not be obvious during a standard environmental review. PFAS are often used because they can handle harsh chemicals, cleaning, sterilisation, and repeated use. For example, they may be found in lined vessels, gaskets, seals, tubing, membranes, filters, coatings, high-purity water systems, lab supplies, fire protection systems, cleanroom materials, packaging, and equipment used to make active pharmaceutical ingredients (API), sterile injectables, biologics, and oral medicines. Some API can also be PFAS, depending on the definition.

PFAS can also enter a facility through the materials and services used to make or package medicines. This may include raw materials, intermediates, single-use systems, container-closure parts, blister packaging, stoppers, plungers, seals, outsourced API manufacturing, and contract manufacturing.

For pharmaceutical companies, even small changes in equipment or raw materials can introduce complications. They may need technical review, testing, validation, stability assessment, regulatory documentation, and input from quality, regulatory affairs, procurement, environmental, health and safety (EHS), and manufacturing teams, and, potentially, customers.

The goal is not just to find out whether PFAS are present at a site. It is to understand where PFAS could affect important products, approved processes, good manufacturing practice (GMP) systems, and future regulatory expectations. Where PFAS are determined to be present, understanding the potential risks that could result from exposure to PFAS in operations, waste streams, waste management and recycling practices, and products, for example, can also be important.

Assess enterprise-wide risk drivers

PFAS were once considered mainly a contamination or cleanup issue. Today, pharmaceutical companies are facing broader questions. Where are fluorinated materials used in product-contact equipment or other critical systems? Could future PFAS restrictions affect approved manufacturing processes or locations, or could they affect how medicines are packaged? Are there PFAS concerns at older manufacturing, research and development, or waste management sites? What happens if a supplier changes or stops making a material the business depends on?

These questions elevate PFAS from an environmental issue to an enterprise risk management challenge. For pharmaceutical companies, these questions can affect GMP compliance, product quality, manufacturing continuity, wastewater permits, packaging plans, supplier qualification, product stewardship, due diligence, financial planning, and reputation with regulators, health systems, patients, and partners.

Looking at PFAS this way helps companies move beyond one-off compliance tasks to understanding how PFAS could affect products, operations, investments, and market access over time.

Evaluate supply chain vulnerabilities

Pharmaceutical supply chains can be exposed because PFAS-containing materials often do very specific jobs. They may be used in tubing, gaskets, filters, membranes, coatings, seals, pumps, valves, analytical equipment, single-use systems, and packaging. These parts often have to meet strict standards for performance, sterility, compatibility, and product safety. If a supplier changes a material, stops making it, or cannot explain what is in it, the impact can go well beyond purchasing.

Getting answers can be difficult. A drug manufacturer may need information from API suppliers, excipient suppliers, packaging vendors, equipment makers, contract manufacturers, lab suppliers, and companies further upstream. Some suppliers may have incomplete records. Others may not know whether PFAS are intentionally added, used in processing, or built into a component several steps back in the supply chain.

That lack of visibility can create business, operational, and regulatory risk. Replacing a gasket, filter, tubing set, stopper, or blister material may require supplier approval, technical review, validation, stability testing, change control, and possibly regulatory notification. For products with limited backup manufacturing capacity or complex sterile processes, even a small change can put supply at risk.

Companies that map these PFAS dependencies early are better prepared to answer questions from customers and regulators, identify alternative materials, and decide where technical or regulatory resources are needed most.

Conduct operational risk assessments

Operational risk assessments help companies find PFAS-related issues before they become compliance problems, quality concerns, or business disruptions. In a pharmaceutical facility, this means looking at product-contact and non-product-contact equipment, cleaning and sterilisation processes, high-purity water systems, wastewater, waste handling, permits, fire protection systems, labs, maintenance materials, and past site activities. The assessment should also connect site findings to quality systems, supplier controls, and product portfolios.

These reviews can uncover risks that are easy to miss when PFAS is viewed only as an environmental issue. Examples include undocumented fluoropolymer parts, past use of firefighting foam, PFAS in process wastewater, supplier dependencies linked to approved systems, or legacy operations that could affect expansion, sale, or redevelopment plans. Finding these issues early gives companies more time to evaluate alternatives, plan testing and validation, work with suppliers, and decide when quality or regulatory teams need to be involved.

A strong assessment also creates a clear record of what was reviewed, how risks were prioritised, and why decisions were made. That record can support permit discussions, due diligence, regulatory questions, customer requests, and internal investment decisions.

Build a proactive PFAS management strategy

Not every PFAS issue needs immediate action, and not every material can be replaced quickly in a regulated pharmaceutical environment. A practical strategy helps companies separate lower-priority items from dependencies that could affect supply, quality, or compliance. These may include PFAS-containing parts used in sterile manufacturing, high-purity utilities, primary packaging, API processes, or products with few alternative suppliers. Actions can then be prioritised based on patient-supply risk, regulatory exposure, technical feasibility, validation needs, cost, and stakeholder expectations.

This approach gives companies a clearer picture of potential liabilities, supplier risks, product continuity issues, and future costs. It also helps avoid rushed substitutions and gives EHS, quality, regulatory affairs, procurement, manufacturing, and legal teams a shared plan for responding to PFAS risk.

As PFAS regulations, customer expectations, and supply chain pressures continue to evolve, pharmaceutical companies will need more than point-in-time compliance responses. By building that visibility now, companies can make more informed decisions, prepare for future requirements, and strengthen resilience across operations, products, and stakeholder relationships.