PFAS FREE PREFILLED SYRINGES
The plungers are manufactured without the coatings commonly related to PFS plungers made from butyl rubber.
These coatings contain PFAS and more specifically CF2/CF3, 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
EU PFAS restriction proposal with ‘essential use’ exemption
Valentina Bertato, policy officer at DG Environment, said at Chemical Watch’s PFAS Global 2022 conference that the PFAS restriction process, led by five European countries, was already underway, and the Commission anticipates essential use criteria being agreed only by the end of the year.
“It is going to be difficult that the final criteria and the final procedure for REACH will be used for the PFAS restriction because that process has already started,” Ms Bertato told the online conference.
“The member states are preparing the dossier, but they cannot take into account criteria that don’t exist.”
Ms Bertato explained that given the mismatch of timelines, the aim to ban all uses of PFASs except essential uses, as stated in the EU chemicals strategy for sustainability (CSS), as well as in a request from the European Parliament and Council, “will have to be adapted”.
Instead, she added, the restriction proposal will have to rely on the existing tools, for example analysing specific uses and considering whether there are safer available alternatives, to determine whether the use is essential or not.
Extract from Chemical Watch post 24. March 2022 by Clelia Oziel, Europe correspondent
It is however argued that the economical consequences of banning PFAS for essential use could be elaborate and there are cases where no suitable alternative exists.
Therefore, the implemntation of the proposal will most likely end with including exemptions for essential use.
However, with the wide banning of PFAS and the attempt to perhibit the substance groups to the furthest extend, it should also be a beyond doubt that the environmental challenges it causes is consequential.
Corperate environmental footprint must always be an important factor and we should all seek the most sustainable solutions in all aspects of the companies products and processes.
It should be inavoidable for the pharmaceutical business to search and investigate potential suitable alternatives and we must seek to minimize the use of the “forever chemicals” wherever possible.
Video on the European ban on PFASs prepared by the The Dutch National Institute for Public Health and the Environment (RIVM). Five European states are expected to submit their proposal to restrict all PFASs in the EU by 13 January 2023. Copyright: RIVM.
Effects of PFAS on human health
Typical PFAS exposure pathways
- US National Toxicology Program, (2016); C8 Health Project Reports, (2012); WHO IARC, (2017); Barry et al., (2013); Fenton et al., (2009); and White et al., (2011).
- European Environment Agency, Briefing no. 12/2019 – Title: Emerging chemical risks in Europe — ‘PFAS’ – PDF TH-AM-19-014-EN-N – ISBN 978-92-9480-196-8 – ISSN 2467-3196 – doi: 10.2800/486213
HTML TH-AM-19-014-EN-Q – ISBN 978-92-9480-195-1 – ISSN 2467-3196 – doi: 10.2800/02904
Strandvejen 60, 5.
Phone: +45 2785 1000
CVR/Org. No.: DK-38 72 98 88
INJECTO can deliver prefillable syringes and syringe components for ready-to-use liquid injectables
Clean injection systems...
Our components are high-precision injection moulded and can be provided for syringe solutions that are lubrication free, coating free, silicone oil free and baked-on silicone free
Feel free to contact INJECTO for more information
||This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 875949|