The truth about PFAS regulations in bioprocessing

Seven key takeaways for 2026.

1) Not all PFAS are equal.

Cytiva uses no fluorosurfactants in our PVDF membranes.

Short chain fluorosurfactants (FS) are the primary environmental risk for fluoropolymers. These were proactively removed from our PVDF membrane supply chain more than a decade ago. While the production of some other fluoropolymers still requires the use of FS, FS-free PVDF membranes pose negligible risk to human health and the environment when properly disposed of.

Controlling environmental risks will rightly be one of your highest priorities. Focusing efforts on the management or replacement of fluorosurfactants and small-chain, hydrophobic PFAS coating chemistries will yield the biggest positive impact to the environment while minimizing risks to your manufacturing process. These are not used in PVDF membranes from Cytiva and may be hidden in some alternatives that may be seen as non-PFAS containing.

Figure 1: Manufacturing steps and PFAS assessment of selected membranes

2) Are there any environmental risks of using PVDF membranes?

Cytiva’s supply chain uses PVDF manufacturers that have implemented site-level environmental control measures to reduce potential emissions. These are consistent with ECHA (section 4m) requirements for continued production.

End-of-life options for PVDF include incineration or mechanical recycling. The latest research demonstrates the successful mineralization of fluoropolymers with negligible emissions1,2.

^[1]Gehrman et al. (2024), Mineralization of fluoropolymers from combustion in a pilot plant under representative european municipal and hazardous waste combustor conditions. Chemosphere’ 143403 https://doi.org/10.1016/j.chemosphere.2024.143403

^[2]Troxler et al. (2025), PFAS Destruction by a Hazardous Waste Incinerator: Testing Results. EPA 600/R-25/172 (2025), U.S. EPA Office of Research and Development, 13 Washington, DC.

3) Will ECHA PFAS proposals restrict bioprocessing?

Proportionality of risk is a key tenet of environmental regulation. This supports targeted efforts to control hazards where the risks are greatest while potentially avoiding unnecessary analysis or action in areas of low risk. To date, most critical applications reviewed by ECHA in bioprocessing and related sectors have received the maximum derogations (13.5 yr), including implantable medical devices, coated rubber stoppers, HEPA, injectable pens, and sealing applications.

• In August 2025, ECHA communicated[3] “they have considered alternative restriction options, beyond a full ban or a ban with time-limited derogations for certain applications,” and that “these options involve conditions allowing the continued manufacture, placing on the market or use of PFAS where the risks can be controlled.”
• REACH article 68 requires that any restriction takes into account the socio-economic impact of the restriction. To date, bioprocessing uses have not been addressed by the Risk Assessment Committee (RAC), and bioprocessing is not a sector which will be considered by the Socio-Economic Assessment Committee (SEAC). Some PFAS uses in bioprocessing do fall into sectors identified by ECHA, such as sealing applications and other medical applications, however ECHA has confirmed these will not be included in the SEAC and RAC opinion. By intentionally or unintentionally not addressing Article 68 requirements, it is expected that the bioprocessing sector and uses will remain out of scope of any final restrictions.

³ ECHA/NR/25/24 Aug 2025

4) Is there consensus on the use of PVDF within the bioprocess industry?

Bioprocess organizations including BPSA, BioPhorum, and ASME-BPE have specifically addressed replacement feasibility and validation challenges for PVDF applications. These assessments have highlighted limited availability of alternatives for applications such as sterile liquid filtration, sterile gas filtration, gaskets and virus filtration. It is understood that PFAS fearmongering used to promote the urgent replacement of PFAS-containing filters with non-PFAS alternatives could ultimately hurt biomanufacturers and patients where such alternatives may not be directly equivalent or may incur additional and avoidable costs including, but not limited to, filter validation.

5) Do I need to validate alternatives to my existing PVDF filters?

No. It is expected that bioprocessing will receive the longest 13.5 yr derogation period offered to date by ECHA. They may yet remain out of scope of the proposed ECHA regulations entirely. Despite this, understanding the true environmental risks of materials when validating new components should continue to remain a key consideration in your well-informed decision making.

6) What action should I take in 2026?

Understanding materials and part numbers in your ecosystem that fit the broad definitions of PFAS is still prudent. To help, we have comprehensively reviewed all our products and can provide detailed breakdowns of all PFAS materials and CAS numbers in your recent order history.

We recommend that you stay well-informed to be able to take the right action. Where you commit to making PFAS reductions, ensure your efforts are focused on areas with the most impact. Don’t be led or misdirected by marketing misinformation that may not be supported by good science. Ultimately, we share the same goal; to ensure our industry is socially responsible in managing environmental risks for our children and planet, while continuing to deliver life-changing patient therapies.

7) If you want to specify PFAS-free filters. Cytiva knows membranes.

There are many PFAS-free, low-binding membranes to support a diverse range of bioprocessing applications. Polythersulfone (PES) is the most likely replacement for PVDF in liquid applications. We have more than 35 years of experience of PES sterilizing-grade filters in our Supor™ filter family as well as PES virus removal filters and a range of nylon membranes.

Want to know more? Why not read our other blogs in this subject.

What are PFAS and why should we care?

What action does the bioprocessing industry need to take on the use of PFAS?