The distinction comes down to whether a PFAS-free claim can be substantiated. Analytical testing is only as sensitive as the method used, making it difficult to state with certainty that a material contains zero PFAS. With no current legislation defining PFAS-free thresholds, the speakers use the PPWR as a guide and focus on mitigating risk. “Non-intentional use” is therefore more appropriate for materials where PFAS is not intentionally used in construction, while acknowledging possible trace contamination. This cautious approach is also informed by cases outside biopharma where companies have faced legal action over PFAS-free claims that lacked supporting data.

Current regulations do not require companies to qualify and validate an alternative, and uncertainty remains around which materials may receive derogations. However, waiting could create practical challenges. If restrictions affect materials such as PVDF filters, many biopharma manufacturers could require testing, validation and regulatory submissions at the same time, putting pressure on laboratories and regulators such as the FDA and EMA. Proactive changes may therefore be worth considering when they also deliver process benefits. For example, moving from PVDF to PES filtration may provide higher capacity, better flow rates or require less filtration area, helping mitigate future PFAS-related risk while improving process efficiency. 

Current regulations do not require companies to qualify and validate an alternative, and uncertainty remains around which materials may receive derogations. However, waiting could create practical challenges. If restrictions affect materials such as PVDF filters, many biopharma manufacturers could require testing, validation and regulatory submissions at the same time, putting pressure on laboratories and regulators such as the FDA and EMA. Proactive changes may therefore be worth considering when they also deliver process benefits. For example, moving from PVDF to PES filtration may provide higher capacity, better flow rates or require less filtration area, helping mitigate future PFAS-related risk while improving process efficiency. 

End-of-life disposal is handled by waste-management companies, and destroying PFAS-containing materials can present challenges. Complete destruction may require temperatures above 900°C to address both PFAS polymers and monomers generated through thermal degradation. Many European incineration facilities do not operate at these temperatures, so specialized incineration may be required to ensure adequate destruction. This can increase energy use and costs, while insufficient temperatures may create a risk of localized contamination. Recycling is also not considered an option for these used components.

Requirements depend on the process step and its associated risk. Changing a sterile filter is considered a major change, while components such as gaskets or air filters may be treated differently because they may not be in direct product contact. For biologics, the focus is on comparability rather than demonstrating that the pre- and post-change product is identical. Under ICH Q5E, manufacturers assess whether the change affects critical quality attributes and demonstrate comparability accordingly. Bacterial challenge and leachables testing may still be required. Agreeing on a protocol and acceptance criteria with regulators before testing can help avoid unnecessary studies and ensure the evidence addresses regulatory expectations.

Yes. A post-approval change management protocol (PACMP) can potentially expedite certain changes, with a gasket change given as an example. It allows manufacturers to work with regulators in advance to define what must be demonstrated for comparability and agree on acceptance criteria before testing begins. Testing is then conducted against these predefined criteria rather than generating evidence first and potentially discovering that additional work is required. Once results meet the agreed criteria, the change can be implemented with greater regulatory certainty. This can make the process more efficient while helping avoid unnecessary testing, costs and uncertainty.

PFAS awareness has moved beyond industry into consumer products and mainstream discussion, making some form of EU ruling increasingly likely. However, the specific impact on biopharma remains uncertain. Derogations may be possible because the industry manufactures life-saving medicines, and some applications may still require fluoropolymers. At the same time, alternatives already exist for certain applications where intentional PFAS use may not be necessary. Overall, the potential outcome for biopharma remains “50-50,” with uncertainty around the final form of the regulation and how it will affect the industry.