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

In January 2023, a request to the Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH) was submitted by five member countries of the European Union (EU) proposing a very wide restriction of all per-/polyfluoroalkyl substances (PFAS), with the intent to add them on the REACH Annex XVII list of restricted chemicals before the European Chemical Agency (ECHA). The technical dossier seeks to broaden the restriction to include “any substance
that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom without any H/Cl/Br/I attached to it”, in alignment with the OECD definition of PFAS, thus this updated restriction will include and impact the coatings used for butyl rubber plungers and stoppers.

A senior advisor for REACH PFAS restriction responsible for pharma and medical devices expect when the restrictions are implemented, the proposal will either provide a full ban after a 5 or 12 years derogation period (after the 18 months transition period) depending of the social economic assessment of the ban .

In short, with the coming change, the majority of the coatings used in parenteral primary packaging are by definition PFAS, which will potentially be effected by the restriction proposal. Consequently, the restrictions will impact the ETFE, PFTE and PCTFE used as coating in primary packaging especially on container closure systems for prefilled syringes, cartridges, and vials, so the business should seek alternatives to the use of such.

When pharmaceutical companies choose the supply format and the primary packaging for a drug product, it is ideally for a long time on the market and therefore selecting and using a primary packaging containing PFAS is a risk that should be considered already now.

Whether the pharmaceutical industry should be concerned about the ban of PFAS already now is a highly relevant question, but moreover the questions should be; what can the pharmaceutical business do to prevent the use and spread of PFAS? Are PFAS coatings in primary packaging really a necessity when there are feasible alternatives? Do we wish to participate in the environmental consequences of the manufacturing and using of PFAS?