Packaging

VOLKER DICKFIELD, GLOBAL MARKETING MANAGER, HEALTHCARE AT AVIENT, EXPLORES SUSTAINABLE SOLUTIONS TO REDUCE THE IMPACT OF THE INDUSTRY’S GAS EMISSIONS.

PACKING UP HEALTHCARE EMISSI NS

When we think about the industries that contribute the most to climate change, healthcare might not be the fi rst 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 diffi cult for manufacturers of medical devices and pharmaceutical packaging to know where and how to start reducing emissions.

The healthcare market’s challenge is fi nding solutions that do not compromise safety and comply with strict industry regulations while facing signifi cant 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 biobased polymer solutions.

WHAT ARE MEVOPUR BIO-BASED POLYMER SOLUTIONS? Avient’s Mevopur bio-based polymer solutions are colourants and functional additives using biopolymers as carrier resin that are specifi cally 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 specifi c 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. 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 fossilbased 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 specifi c reduction of greenhouse gas emissions (measured as CO2 equivalent) compared to fossil-based counterparts. Some bio-based polymers even have a consuming CO2 eff ect, 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. Biopolypropylene (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 biobased 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, bioPE, 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.

Medical diagnostic equipment & biotech applications

ALBIS offers the medical industry an unparalleled choice of high performance polymers from renowned producers. This offering is complemented by customized polymer compound solutions tailored to customer’s needs and made by ALBIS’ sister company MOCOM.

We support numerous projects in the medical and pharmaceutical sector as well as for diagnostic equipment and biotechnology applications. Addressing the latest trend towards an increasing use of sustainable solutions our portfolio includes newest and state of the art sustainable polymers which are specifically developed to fulfil the strict regulatory and service needs of the healthcare industry.

albisuk@albis.com

WASTE NOT, WANT NOT

Welcome to the Recycling Medical Plastics feature of Medical Plastics News. 2023 is the year to reinforce recycling with laws changing throughout the globe.

This issue covers all aspects of recycling – discussing innovative devices and facilities, implementing the circular economy into the industry and even advice from sustainability experts.

A company gives its insight on how to recycle one of the most disposed of plastics in the medical sector and a global company shares the news of its technology which breaks down and rebuilds plastic, as well as their large facility made specially to process plastic waste.

It’s Global Recycling Day on 18th March, how will you be implementing this across your company? Have a read throughout the following features for inspiration.

GERTRUD MASURE, EMEAF MARKET DEVELOPMENT MANAGER AND ABIGAIL AGENTIS, AMERICAS MARKET DEVELOPMENT MANAGER AT EXXONMOBIL, EXPLAIN THE IMPORTANCE OF PATIENT SAFETY WHEN IT COMES TO BEING SUSTAINABLE.

the meaning of sustainability

Sustainability is at the forefront of multiple industries, however when we think of sustainability, we think of recycling and the reusing of products, but in the medical industry it’s not always so simple.

For the most part, it’s safe to reuse or recycle a product, such as packaging, but what happens when it comes to syringes and face masks? This is where hygiene and patient safety become a huge factor. Exxonmobil believe that patient safety is a form of sustainability in itself.

PATIENT SAFETY Exxonmobil aim to look at different solutions to try and find ways to keep patients safe whilst being as sustainable as possible.

Abigail Agentis, Americas market development manager, said: “We definitely recognise that sustainability is a key driver across all industries and not just medical. And so that’s definitely at the forefront of our minds when we’re looking at developing solutions for this industry. I would say that we have, within our expanded portfolio, a lot of great new alternatives to existing incumbent materials that could be leveraged towards companies’ sustainability goals.”

Gertrud Masure, EMEAF market development manager, added: “It’s about how can we change and look at different solutions that are important for a patient’s safety - and to me, that’s part of the sustainability story in the same sense as well. It’s like, how can we provide better healthcare in the longer term for patients, for the safety of everyone.”

HOW CAN THIS BE SOLVED? So how can we recycle medical plastics without risking harm to patients? Exxonmobil has developed a technology, called Exxtend, which breaks waste and rebuilds the material, allowing plastic waste to be converted into brand new products.

“The medical industry is also looking at recycling opportunities. Now, of course there is a whole patient safety related to it, so one of the things we are studying and looking into is how our Exxtend technology for advanced recycling of plastic waste to produce certified-circular polymers can potentially play a role in the medical field.” Masure said.

“What the technology basically does is it takes mixed plastic waste, breaks it down to its molecular building blocks and rebuilds polymers using existing petrochemical facilities. This results in virgin equivalent, high performance polymers that can comply with the industry’s highest requirements on cleanliness, purity and product safety.”

THE FINISHING TOUCH Exxonmobil has created a largescale facility in Baytown to process plastic waste. As of June 2022, the company had processed more than 5,000 metric tonnes of waste. Upon completion, Exxonmobil states it’s now among North America’s largest advanced plastic waste recycling facilities, with a goal to recycle 30,000 metric tonnes of plastic waste each year.

Exxtend can be rapidly scaled to process a wide range of plastic waste. The company aims to have the advanced recycling capacity of up to 500,000 metric tonnes per year by the end of 2026, globally.

MARTIN GADSBY, VP OF OPTIMAL INDUSTRIAL AUTOMATION, LOOKS AT HOW INDUSTRIAL AUTOMATION CAN SUPPORT THE CREATION OF A CIRCULAR ECONOMY FOR MEDICAL PLASTICS.

Got it down PAT

Plastic can be found everywhere in medical and healthcare settings – in fact, we probably cannot imagine sanitary practices in the sector without it. Given that the material is so ubiquitous, it is no surprise that hospitals and other health centres generate large volumes of plastic waste. However, using data-driven chemical recycling strategies, this can be turned into a valuable resource, supporting circularity while potentially reducing costs.

However, the sector uses massive volumes of disposable medical plastics. It has been estimated that these represent approximately 25%-30% of landfi lled medical solid waste. When looking at the UK National Health Service (NHS), 133,000 tonnes of plastic are disposed of every year, with only about 5% of this currently being recovered.

As these products are rarely recyclable at their end of life, they contribute to plastic pollution. Moreover, as most components are made from oil-based virgin raw materials, they are advancing the depletion of non-renewable sources. How can healthcare professionals overcome this?

GOOD CHEMISTRY Currently, mechanical recycling is the most widely used strategy. However, this comes with key limitations in terms of the types of polymers that can be processed and produced as well as end product quality. Materials produced in this way typically feature inferior physicochemical properties, due to the presence of impurities and other contaminants, the popularity of mixed polymer blends, the presence of multilayer materials and the heterogeneity of the initial waste. Chemical recycling methods, which are typically based on pyrolysis, depolymerisation or solvent-based selective polymer recovery, off er a valid alternative to address these challenges. They can address feedstock variability, remove coatings, dyes and other substances from medical equipment as well as separate the components of mixed materials. As a result, advanced chemical solutions can deliver high-purity monomers and polymers with virgin-like properties.

An obvious strategy for recycling facilities is to adopt robotic and/or machine vision systems to perform rapid and accurate sorting of large volumes of waste. When looking at the chemical reaction, separation and purifi cation stages, automated process control strategies should be applied to optimise the operating conditions.

ON THE PAT WATCH A highly eff ective solution is setting up self-regulating processes driven by Process Analytical Technology (PAT). More precisely, this framework consists of univariate and multivariate analysers that monitor the physicochemical properties of the plastic feedstock and process conditions, preferably via real-time, on-line measurements. Among the most suitable analytical devices that can be used are Raman and mass spectrometers, and nuclear magnetic resonance (NMR) instruments.

The data generated by these analysers is then shared with a PAT knowledge management platform, such as synTQ from Optimal Industrial Technologies. This platform combines the information via data fusion strategies and feeds chemometric and other predictive models to provide in-depth insights. These include determining the expected physicochemical properties of end products, when processes are complete and can move on to the next stage, as well as how the process can be optimised to meet quality and effi ciency targets.

ENABLING MEDICAL PLASTIC CIRCULARITY Ultimately, smart chemical recycling plants can set up automatic feedback and feedforward closed-loop control. This can maximise yield, throughput, recovery rates and product purity while minimising cycle times, energy usage and solvent utilisation, if the recycling route requires it, as well as reduce waste and reworks. As a result, it is possible to limit the environmental impact of recycling activities and make them commercially viable, delivering monomers or polymers at a cost that can compete with virgin-based counterparts.

A skilled automation specialist with experience in implementing PAT-driven solutions, such as Optimal Industrial Automation, is a key ally in the creation of successful, future-oriented processing facilities for medical plastic waste. By partnering with an expert in the industry, companies can drive forward fi nancially feasible circularity in the sector and benefi t customers with economical, highquality, greener products.

properties of end products, when processes are complete

TOBIAS JOHNSEN, CONSULTANT AT VINYLPLUS, DISCUSSES THE POSSIBILITY OF A CIRCULAR PLASTIC ECONOMY IN HEALTHCARE.

Is it p ssible?

The use of plastics in healthcare presents a paradox. As a direct product of the petrochemical industry’s breakthrough after World War II, plastics paved the way for a tremendous innovation within medical devices. Suddenly it was possible to manufacture sterilisable, single-use medical equipment at a price that traditional materials such as metals, ceramics and glass could not beat. With rising living standards in many countries in the following decades, the demand for quality healthcare grew dramatically, which plastics helped to fulfi l. The other side of the coin was seen during the Covid-19 pandemic. Though single-use plastic medical devices played an essential role in the prevention and control of infection in hospitals, Covid-19 highlighted the challenges of properly managing and discarding the same life-saving devices after use.

WHAT’S THE SOLUTION? The enormous amounts of waste generated has obliged hospitals to reconsider their waste management systems towards more cost and environmentally effi cient practices. In addition, the increased focus on plastics in society acts also as a driver to make the use of polymers used in health settings more circular. Some call for a phase-out of plastic in healthcare as a solution to the waste crisis. Though reduction is on top of the waste pyramid, it will be very diffi cult for health professionals to not have access to safe, reliable plastic-based medical devices in critical situations. In addition, the ageing population in some countries and rising incomes in others mean the demand for quality, aff ordable healthcare will not subside in the future. The same voices then call for reuse, and of course this idea is appealing, it remains to be seen whether washing and re-sterilisation is practically and economically feasible for the many diff erent low-cost disposable medical devices that doctors, nurses and other health staff rely on for diagnosis, treatment, and care. Recycling is a step down from reuse in the waste pyramid but preferable to incineration or landfi ll. Here, the PVC industry has taken a leading role. In early 2022, the VinylPlus Med recycling programme was launched to accelerate sustainability in European healthcare. Starting in Belgium, the aim is to help hospitals sort their PVC waste stream. Currently 10 hospitals have joined VinylPlus Med, with more than 35 on the waiting list.

BUT WHY PVC? First, market studies show PVC is the single most used polymer for disposable medical devices such as oxygen masks, tubing and dialysis bags. Importantly, PVC will remain the material of choice in the years to come. Successful recycling depends on volume, so it makes sense to start with the most used plastic. Second, PVC is easily recyclable due to the polymer’s chemical composition. As PVC can be made rigid and soft, it is also possible to manufacture mono-polymer products – another key to successful recycling. Medical grade PVC is sought after by recyclers and plastic converters, as it can be turned into a wide variety of applications. An example is vinyl wall covering, which can incorporate regrind PVC obtained through an environmentally benign process. After many years, the wall covering can be recycled and used in new wall covering. When mentioning PVC in the context of healthcare, the discussion always gravitates towards the additives that give PVC its unique functional properties such as softness and fl exibility. It must be stressed that only REACH-compliant non-DEHP PVC waste is collected. To meet this objective, a cost effi cient portable near-infrared (NIR) scanner has been developed. By use of artifi cial intelligence, the scanner can detect the presence of DEHP in the waste stream. This scanner can be used on PVC waste streams from other sectors, thus facilitating an easy sorting of fl exible PVC.

NICOLLE PORTILLA, SOCIAL MEDIA MANAGER AT RTS, SHARES HOW TO IMPLEMENT CIRCULARITY IN THE MEDICAL PLASTICS FIELD. The circle of life

Plastic is one of the essential materials used in the global economy. It has wide-ranging applications across the biggest industries and is a cost-effective solution that is easy to produce and transport. The healthcare industry is one of the fields that makes extensive use of plastic, as it is an incredibly versatile material that is used in the manufacturing of medical equipment.

However, plastic production is one of the leading causes of pollution worldwide. With over 380 million tons of plastic produced every year, a huge portion of it is never reused but simply dumped in landfills and oceans. Healthcare facilities overall are known to generate tens of thousands of tons of plastic waste per day. The irony is that around 85% of hospital waste is free from any contamination and health hazards — making it ideal for recycling and reusing.

THE CHALLENGES OF ADOPTING CIRCULARITY IN MEDICAL PLASTICS

The circular economy is a production and consumption model that has reusing, recycling, and repairing existing materials at its core. There are, however, many challenges within adopting circularity in the medical plastics industry, such as:

Regulatory issues and market barriers

There is not enough budget and willingness to invest in new and better recycling infrastructure and practices.

On top of that, healthcare is a field that is under heavy regulation by government bodies. Most manufacturers of medical devices follow strict rules and are hesitant to deviate from the established formula. Introducing new materials into the manufacturing process will most likely be problematic in terms of regulation and industry standards.

Inconsistent performance

Another thing to keep in mind regarding medical plastics is that they need to meet certain requirements in order to be effective. In addition to overall strength and flexibility, manufacturers also have to consider sterilisation compatibility, permeability, and microbial barrier characteristics. If a product does not meet the standards in those categories, it will not perform as needed.

Unfortunately, as of now, incorporating recycled content in medical plastics results in inconsistent performance. Research has shown that there are significant challenges in terms of maintaining product integrity and overall quality.

Problems with traceability

There are specific standards and regulations when it comes to the traceability of medical devices and products. In order to find the cause of issues quickly and effectively, manufacturers are required to keep a Device History Record (DHR). DHR essentially traces any material content used in a product back to its source. Therefore, using recycled plastic for medical materials is quite impractical and in direct contradiction to those regulations.

IMPLEMENTING CIRCULARITY IN MEDICAL PLASTICS

While fully adopting circularity in medical plastics is still not possible, there are many new developments that will make the process easier. Technological advancements and legislative incentives will make the transition smoother for medical plastic manufacturers across the globe.

Innovation in recycling tech

The technology involved in medical plastic recycling is constantly undergoing changes and improvements. The main issue is that recycled plastics often suffer from downgrades in quality, impacting their performance and durability. However, new developments will make it possible to recycle plastic more effectively, resulting in a product that performs as if it was manufactured with brand new materials.

Improved infrastructure and legislation

Combating pollution and climate change is more needed than ever, and the topic is on the agenda of many global alliances, associations, and governments. As a result, more and more investments are being made across the globe to improve recycling infrastructure and technology. What is more, local governments are further regulating the plastic industry while incentivising manufacturers to adopt circularity in their processes.

Such developments will help deal both with regulatory challenges and market limitations. We can expect medical device manufacturers to rapidly implement circularity, as the barriers and complications surrounding the transitions disappear in the near future.

Using recycled materials in non-sterile products

As we already mentioned, there are strict regulations regarding the plastic used in medical devices. While recycled materials currently have performance issues, tests show that they are quite usable for non-sterile products and packaging. Certain devices and packaging do not need to be sterile, since they are sanitised right before use by hospital personnel. Other medical devices, such as disposal bins, are not required to be sterile at all. Until recycling technology improves and proper infrastructure is created, manufacturers should focus on using recycled materials for such products as much as possible.

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T: 023 8048 3000 W: www.alphalabs.co.uk