Used in consumer products since the 1950s, perfluoroalkyl and polyfluoroalkyl substances (PFAS) are synthetic chemicals with strong fluorine-carbon bonds, earning them the nickname ‘forever chemicals’ due to their resilience and durability. Due to this resistance to degradation, PFAS have been accumulating in the environment and some PFAS are highly mobile, causing them to migrate far from their original contamination site.

We now know that many PFAS are toxic and can disrupt both the endocrine system and lipid metabolism. In particular, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are widely used chemicals within the PFAS group. The International Agency for Research on Cancer (IARC) has evaluated the carcinogenicity of PFOA and PFOS and classified PFOA as carcinogenic to humans (Group 1) and PFOS as possibly carcinogenic to humans (Group 2B)[i].

Amid growing consumer concerns, the European Chemicals Agency (ECHA) is now reviewing a proposal by five EU member states for a ban on PFAS across Europe[ii] due to come into effect in 2025. However, PFAS is widely used in all manner of products, from packaging to clothes.

There are industry-wide concerns that such a ban could severely disrupt pharmaceutical supply chains, as PFAS are widely used in primary packaging and manufacturing. Finding replacements will be difficult, time-consuming, and expensive. Even if the industry finds alternative materials, reauthorisation by regulators will be required.

Additionally, the sector is asking if a blanket ban is actually warranted. Pharma packagers say that most of the chemicals used by the industry are polymeric PFAS which do not pose the same environmental or human health implications as monomeric PFAS.

Why are PFAS so important to the industry?

The pharmaceutical industry relies heavily on fluoropolymers, a subset of PFAS, for safe manufacturing, distribution and use of medicinal products. Fluoropolymers are chemically inert and offer oil, dirt and water repellence in addition to electrical and thermal insulation. As a result, the chemicals are widely used across the industry for laboratory instruments, gaskets, caps, valves, filters, coatings, refrigerants and many more.

Fluoropolymer-based coatings are also crucial in injectable formulations, particularly those sensitive to extractable and leachable (E&L) content, such as large-molecule biologic drugs. Although rare, toxic E&L in primary packaging can pose a serious health concern, so fluoropolymer coatings act as a barrier between the drug product and the packaging materials. Datwyler, a leading provider of elastomeric closures for parenteral packaging applications, has offered this technology since the mid 1990s.

With a ban on all PFAS due to take effect this year, how are packaging companies like Datwyler preparing?

Future-proofing the industry

Pharmaceutical manufacturers and packagers are now awaiting ECHA’s response to industry feedback, particularly regarding the proposal’s inability to account for differences between monomeric and polymeric PFAS. Derogations and extended transition periods are expected – but not guaranteed – for medical applications of PFAS due to their critical nature and the limited availability of environmentally friendly alternatives.

Dr Bram Jongen, PhD (Doctor of Chemistry) is Vice President of Materials and Surface Technologies at Datwyler Group, a leader in parenteral drug packaging.

“The worst outcome would be a full ban on both monomeric and polymeric PFAS enforced in due time,” says Dr Jongen. “It is more likely that ECHA will understand and accept the differences between monomeric and polymeric PFAS, and that they are going to define a way of working with fluoropolymers that means they might be accepted in the long run.”

Datwyler is optimistic about the potential exclusion of pharmaceutical fluoropolymers from the PFAS ban due to their non-toxic and non-water-soluble nature, as well as the benefits they bring to the safety of parenteral packaging. However, restrictions against fluorosurfactant use will likely remain, requiring pharma companies and suppliers to redesign products containing this type of PFAS, dependent on the availability of non-fluorosurfactant (NFS) grade polymers, which is uncertain.

For a full and detailed exploration of how a EU wide ban on PFAS could affect the pharmaceutical industry and how Datwyler is responding, download the free paperbelow.

[i] https://www.iarc.who.int/news-events/iarc-monographs-evaluate-the-carcinogenicity-of-perfluorooctanoic-acid-pfoa-and-perfluorooctanesulfonic-acid-pfos/

[ii] https://echa.europa.eu/-/echa-and-five-european-countries-issue-progress-update-on-pfas-restriction