How we can reduce the impact of the medical industry's gas emissions
Volker Dickfeld, global marketing manager healthcare at Avient, explores sustainable solutions to reduce the impact of the industry’s gas emissions.
When we think about the industries that contribute the most to climate change, healthcare might not be the first to come to mind. However, a Health Care Without Harm and ARUP report found that 71% of the sector's emissions are primarily derived from the healthcare supply chain through the production, transportation, and disposal of goods and services. This can make it difficult for manufacturers of medical devices and pharmaceutical packaging to know where and how to start reducing emissions.
The healthcare market's challenge is finding solutions that do not compromise safety and comply with strict industry regulations while facing significant issues in securing the supply of materials. The good news is that there is an easy, fast, and controlled way to start reducing the carbon footprint of medical plastics: switching to Mevopur bio-based polymer solutions.
What are Mevopur bio-based polymer solutions?
Avient’s Mevopur bio-based polymer solutions are colorants and functional additives using biopolymers as carrier resin that are specifically for use in healthcare applications. The portfolio includes solutions formulated with and for bio-based polypropylene, polyethylene, polycarbonate, acrylonitrile butadiene styrene (ABS), and styrenic resins. Mevopur bio-based polymer solutions are available as concentrates (masterbatches) to dilute at a specific ratio into the virgin polymer during the plastic conversion process or ready-to-use formulations that already contain the right amount of colour. They are drop-in solutions that can be used the same way as fossil-fuel-based polymers in injection moulding, blow moulding, and extrusion, which means there is no need for additional equipment or manufacturing process adjustment. And as with all Mevopur solutions, these products come with well-characterised raw materials, fully secured change management beyond ISO 13485, and full support with regulatory documents.
This also means projects involving bio-based polymer solutions can be managed as any medical plastic colouration project with fossil-based polymer solutions. Possible applications include casings of drug delivery devices (e.g., autoinjectors, syringes), diagnostic devices (e.g., blood glucose monitors, pregnancy tests), or pharmaceutical containers and caps. The colour concentrates and pre-coloured formulations are developed in bio-based polymers by a team of experts in colour matching for healthcare applications. Functional additives can be combined with the colour to provide additional features such as laser marking, laser welding, improved protection during irradiation sterilisation, UV/VIS protection, friction reduction, antistatic properties, or protection from thermo oxidative degradation.
Sustainability impact
The bio-based polymers used in these Mevopur solutions are produced using non-fossil resources to build the monomers. All bio-based polymers have a specific reduction of greenhouse gas emissions (measured as CO2 equivalent) compared to fossil-based counterparts. Some bio-based polymers even have a consuming CO2 effect, meaning the raw materials consume more CO2 than emitted, resulting in a lower carbon footprint material. This is the case with bio-polypropylene and bio-polyethylene. Bio-polypropylene (bio-PP) can achieve the highest bio-content, up to 100%, along with bio-polyethylene (bio-PE) at 95%. In comparison, other similar products typically contain between 70% and 95% of bio-content – calculated to ASTM D6866 standard. This means bio-PP and bio-PE are good options when switching to bio-based polymers.
Therefore, Avient started with these polymers to develop their first bio-based polymer solutions, launched last year at Pharmapack. They are particularly interesting for pharmaceutical packaging due to higher production volumes, making the sustainability impact more significant. Eventually, any switch to bio-based polymer solutions, no matter the application or the resin, will be a step forward to a reduced carbon footprint and increased sustainability. In addition, the plastics made from bio-PP, bio-PE, bio-PC (polycarbonate), bio-ABS, and other bio-styrenics are recyclable through the same recycling channels as conventional fossil-based polymers.
Risk mitigation and regulatory compliance documentation
The Mevopur bio-based polymer solutions follow the same concept of enhanced risk mitigation as all Mevopur products. The first cornerstone of the concept is the pre-testing of raw materials, including bio-based polymers, to relevant medical standard protocols. Those include ISO 10993-1, USP chapters <87> and <88> (including Class VI), European Pharmacopeia monographs 3.1.3 and 3.1.5. (polyolefin packaging materials), USP <661.1> (polyethylene) and ICH Q3D guidelines for elemental impurities. Documentation for this testing is provided to customers to help increase the certainty of regulatory compliance for their devices and packaging.
In addition, Drug Master File (type III) and/or Device Master File registrations by the Food and Drug Administration (FDA) and food contact according to U.S. FDA and EU norms are also generally available for all Mevopur products.
Another cornerstone of the risk mitigation concept is manufacturing Mevopur colourants and additives in four ISO 13485:2016 third-party certified sites in Asia, Europe, and North America. All four sites use a globally harmonised raw material range which facilitates the transfer of a project from one region to another and provides backup options to increase the security of supply. For increased risk mitigation, all sites also offer change control agreements beyond Chemical Abstracts Service (CAS) number.
The future of sustainability in healthcare applications
Avient supports the healthcare industry with sustainable material solutions under the Mevopur brand name. This includes developing more solutions in existing sustainable resins and qualifying new resin classes when available. The sustainability aspect can be further enhanced by combining bio-based polymers with functional additives.