lubrigone plungers are made from a (recyclable) TPE specialty compound.

The plungers are manufactured without the coatings commonly related to PFS plungers made from butyl rubber.
These coatings contain PFAS, more specifically contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom without any H/Cl/Br/I attached to it, which pose a serious challenge to the environment.

ECHA defines PFAS as “forever chemicals” because PFAS is almost impossible to break down and studies have shown that it has contaminated rainwater, drinking water and groundwater, and when humans are exposed to and consume PFAS it accumulates in the body and can cause lowered immune system, elevated cholesterol levels, liver damage and various kinds of cancer.

The lubrigone material is biocompatible and therefore does not require a coating to protect against chemicals leaching into and interacting with the drug product.

lubrigone contributes to the global environment by offering primary packaging components entirely free of PFAS coatings.

Both our silicone oil free plungers and our auto disabling devices are PFAS free

Due to increasing scientific and regulatory concern, PFAS restriction initiatives are emerging worldwide. Within the EU, five Member States have submitted the most comprehensive restriction proposal ever developed under Annex XV of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) framework.

The restriction scope includes both non-polymeric (e.g., perfluoroalkyl carboxylic acids, perfluorocarbons) and polymeric PFASs (e.g., fluoropolymers, perfluoropolyethers), thus the proposed restriction addresses all PFASs within scope irrespective of whether they are substances on their own, are constituents in another substance (including as an impurity or additive) or are present in mixtures or in articles.

In August 2025 ECHA released the 14th edition of the
restriction proposal in which they included a new sector carving out pharmaceutical excipients and primary packaging, such as prefilled syringes, amongst others.

This sector includes the topic: “6.v – Coated plungers in prefilled syringes” which is suggested to follow the Restriction Option 2 having a derogation and transition period of 13.5 years after Entry into Force (EiF).

In addition to the established 18-months transition periode in the Restriction Proposal (RO1) and the 6,5 or 13,5 years derogated Restriction Option (RO2), the proposal now introduces a third Restriction Option (RO3) having a strict continued use condition under a risk-managed pathway with the conditions that:

• A justification can be made that no other suitable alternative exists
• Risk management of the PFAS supply chain include reporting obligations and site-specific PFAS management plans to monitor emissions and track progress toward substitution.

Consequently, there are two possible roadmaps laid out for prefilled syringes:

• RO2 – 13,5 years until PFAS in prefilled syringes are restricted, or
• RO3 – continued use permitted only under strict, risk-controlled conditions and demonstration that no suitable alternatives exist

In the pharmaceutical sector, even a 13,5 year transition is considered short, requiring timely strategic planning – particularly for new product development.

Should the topic ”6.v – Coated plungers in prefilled syringes” obtain RO3, there are, besides the required actions, other important deferred risks to consider.

As other major PFAS utilising sectors phase out their use, global production volumes are expected to decline. This may prompt suppliers to exit the market – as already demonstrated by 3M, one of the previously largest PFAS suppliers – and this could lead to supply chain disruptions and significant cost increases.

Thus, regardless of which Restriction Option is ultimately implemented, this industry must actively engage in the topic, and from a risk-based approach, with a sustainability mindset, evaluate each individual component in their applications and assess: “Is there a suitable alternative?”