As packaging waste exceeds 500 million tonnes annually, polluting our forests, rivers and seas, the drive to reduce and recycle packaging of consumer goods is gathering pace, with more and more packaging designed for recycling, and single-use packaging being banned from many applications. The circular economy is slowly becoming reality.
Primary packaging for Pharmaceutical and Medical Device applications has always been given a free pass from these changes, citing patient and product safety as the reasons not to change.
But has the time come for the Healthcare Industry to step up and take responsibility?
Introduction
The volume of packaging waste globally is over 500 million tonnes, of which around 80 million tonnes is generated in the European Union, and a similar volume in USA. Despite significant advances in recycling, consumer education and packaging design, the growth in packaging consumption continues to outstrip recycling capacity and technology advances. Additionally, although the total volume of packaging waste is stabilising in many OECD countries, this is driven by a reduction in paper, cardboard and glass packaging. Significantly, plastic packaging waste continues to increase, and represents almost 150 mio tonnes per year. In USA, only 14% of this is recycled, in EU the data is better at 38%. Globally, 22 mio tonnes of plastics leak into the environment every year, ending up in our rivers, lakes, seas and forests.
Whilst consumer products have moved heavily away from single-use plastics, the healthcare industries have clung on, with the UK’s National Health Service being the largest single-use plastics user in Europe.
Although Pharmaceutical and Medical Device packaging waste represents only around 1% of overall packaging waste, the industry mindset is that it cannot be recycled, and almost all of it ends up in landfill or being incinerated. As the producer of 4.6% of global greenhouse gas emissions, the Healthcare industry is feeling the pressure to reduce its environmental impact.
The Importance of Plastics in Packaging
Plastics play a vital and unavoidable role in the primary packaging of pharmaceutical products and medical devices. They are critical to the protection and shelf life of the content, by providing barrier to microbes, moisture, oxygen and light. Ensuring products are in perfect condition after two years, and that the packages open without damage or contamination, are much higher demands than for most consumer goods packaging.
Adding in the critical need for correct labelling, child-resistance, and the potential of counterfeit, the regulatory environment of both Pharmaceutical and Medical Device packaging is extremely risk-averse and restrictive, making change of packaging a costly and time-consuming activity.
The most common plastics in Healthcare packaging are PE, PVC, PET and PP, as these provide an excellent combination of protection and low interaction with the sensitive content. However, especially in flexible packaging, these plastics are mostly combined with other polymers or with aluminium to enhance the barrier properties, creating multi-material laminates that are near-impossible to recycle.
Blister packaging is the most popular form for tablets around the world, representing around 60% of all doses, and PVC is used in over 90% of blister packs, usually with an aluminium foil lid.
Glass vials, syringes and bottles are still heavily used, especially for vaccines. However, these have extremely high costs of production and recycling, as well as breakage risk, and are slowly being replaced by plastic alternatives. Plastic bottles, more commonly used in US, are more frequently made of single polymers, in particular PET and PE, theoretically allowing them to be sorted into one of the plastic recycling streams.
Medical device primary packaging more often uses PET, PE and PP, again, frequently combined with paper and barrier materials such as oPA and EVOH. The plastics in medical device packaging have the additional functionality of allowing the sterilisation process to take place, whilst maintaining a microbial barrier post-sterilisation.
With advances in paper production, especially reinforced and coated or impregnated paper, these can now provide greater barrier and mechanical protection, and can be considered as viable alternatives for some Pharmaceutical and Medical Device products.
With this heavy reliance on multi-material plastic-based packaging, and a cautious regulatory environment, it is unsurprising that Pharmaceutical and Medical Device companies are reluctant to commit to a major change.
The Packaging Industry as Key Enabler
For over 20 years packaging companies have provided more sustainable options to standard packaging, downgauging foil and film thickness, optimizing design to reduce pack size and components, and offering PP or PET as an alternative to PVC. However, the basic packaging has not changed for 40 years, and only in the past 5 years has the pace of innovation increased. Large packaging companies such as Amcor made pledges to ensure all packaging is recyclable by 2025, and this has since been adopted across the healthcare packaging industry. This commitment was necessary to drive the sustainability agenda forwards, moving from an incremental to a transformational mindset, and collaborating with global organisations such as Ellen MacArthur Foundation and the Healthcare Plastics Recycling Council.
The major primary packaging manufacturers have taken huge strides towards mono-polymer packaging, moving away from PVC in favour of PET, PP and PE. These innovations have been enabled by investment in both R&D resources, as well as advanced converting technologies.
With the broader availability of recyclable solutions, the major Pharmaceutical companies have shown a greater willingness to trial these new packs, in particular for the Consumer Health and OTC markets, where end-users and retailers have a greater influence in the decision-making, and the pressure to show eco-friendly credentials is greatest.
The largest producer of PVC blister base film, Klockner Pentaplast, was first to launch a monopolymer PVC-free blister in 2021 with kpnext™, a PET thermoformable base film, as an alternative to low-barrier PVC blisters, targeting the Consumer Health and OTC segments.
Since then, Amcor has launched an all-PE blister called Amsky™, which achieves a medium moisture barrier, and allows use for a broader range of medications, including prescription drugs. This has been followed by Liveo Research, Tekni-Plex, Südpack Medica and Etimex with their all-PET and all-PP blisters. These also promise medium barrier, with higher barrier options in development. The major PVC producers have been teaming up with film and laminate producers such as Huhtamaki and adapa to provide lidding films, marking a recognition that collaboration is required to deliver results here.
Medical device packaging has shown similar advances, as the producers aim to reduce the non-recyclable content to an absolute minimum, in particular limiting difficult-to-recycle materials such as oPA and PVC.
Some challenges remain to be solved in the higher barrier ranges to remove aluminium laminates and harmful vinyl chlorides and fluoropolymers from pharmaceutical blisters:
Higher barriers provided by PVdC and PCTFE, representing around 15% of blister packs, have not yet been achieved with monopolymer blisters
Aluminium cold form blisters represent the highest barriers to moisture, oxygen and light, and are around 20% of all blister packs, often prescription medications. Whilst these can be recycled in the aluminium stream, this is only achieved by grinding and incinerating, to recover the aluminium, and is expensive, with limited results.
The key messages here are that the packaging industry is starting to deliver the goods, providing Pharmaceutical and Medical Device companies with a range of recyclable alternatives, and they are prepared to work together to achieve this. So how quickly before change is visible?
Significant Hurdles Ahead
Recyclable packaging solutions now available cover something like three-quarters of Pharmaceutical and Medical Device applications, and trialling at Pharma and Medical Device companies is gathering pace, particularly for new product launches. However, even if these packages are replaced in the coming few years, there are still major challenges to achieve a circular economy, for example:
Regulations today prevent post-consumer recycled (PCR) content being used in primary pharmaceutical and medical packaging. Patient safety demands that there can be no risk of contamination entering the value chain, and current mechanical recycling processes cannot guarantee this
Contamination of Medical and Pharmaceutical packaging with biological, chemical or toxic materials, even in empty packages, is considered too risky. For this reason, finished packaging is usually incinerated, or simply goes into the trash and landfill, despite over 80% of healthcare waste being classified as non-risk
Collection and separation of used packaging is under-developed, in particular for home used medications and devices. A used pack may contain some residual medical or pharmaceutical content, and currently these are not accepted for recycling. Advice generally is to put used healthcare packaging in the trash. Some schemes have started to collect completely empty blister packs, such as by Terracycle in Australia and Superdrug in UK.
Moving to a Circular Economy
As the packaging producers have shown, collaboration along the value chain is needed to achieve circularity in healthcare packaging.
First and foremost, the Pharmaceutical and Medical Device Manufacturers have to advocate for change. In addition to driving the change to sustainable and recyclable raw materials, the leading companies should drive the need to change regulations to make it easier for recycled plastics to safely enter the pharmaceutical packaging value chain.
The product design can ensure the optimum use of both product and packaging. For example, coated tablets leave less residue on the packaging, making separation and cleaning much easier. Designing medical devices, such as drug delivery and diagnostic devices, to be multi-use will significantly reduce the amount of packaging needed.
Package design should ensure the efficient use of materials, with the Pharma and Medical Device companies collaborating early and closely with the packaging producers. Alternatives to plastic-based flexible packaging, such as the greater use of paper, rigid plastic bottles and trays, can make a recyclable mono-material pack easier to realise. In addition to the primary packaging, consideration needs to be given to secondary packaging such as leaflets, as these can be a great source of waste, which could be replaced by electronic information on the primary packs and secondary cartons.
Continued investment in packaging production technologies is required to enable further innovation towards mono-material packs across the whole range of Pharmaceutical and Medical Device packaging formats.
When dispensing or supplying the product, ensure the correct quantities, avoid over-supply, and educate the consumer about how to use the products and dispose of packaging correctly.
Ensuring correct usage requires continued education and communication. The packaging design can help simplify usage, and it is also a critical carrier of information. Smart packaging and digitally-printed data can provide users with easy-to-understand information to minimize waste and improve safety. Standardisation of medical devices will also improve patient compliance.
The weakest link in the chain currently is the disposal and collection of the empty packs. There are currently no widespread schemes to allow users to return empty or part-empty packs. Unused pharmaceutical products are often flushed into the water system, contaminating the environment. Here, collaboration between the healthcare industry, local and regional governments, waste processing companies and the regulators is required to allow unused medicines and devices to be collected, separated, cleaned and for the packaging to enter the recycling streams.
Finally, further advances are needed in mechanical and chemical recycling processes to make the recycling of PET and polyolefins more widespread and cost-effective. Processes such as hydrolysis, pyrolysis, gasification are well-established in the depolymerization of plastics, to allowing their return into chemical production.
Summary
The healthcare primary packaging producers have made great strides in developing single-material packaging, and especially monopolymer plastic packaging. Add to that the common use of rigid plastic bottles and trays, and the advances in paper technologies, there are few reasons not to adopt recyclable packaging for the majority of healthcare applications.
There is some way to go before technology allows all healthcare packaging to be fully recycled, and this requires investment throughout the value chain. It cannot be left to the packaging companies alone to carry the cost of innovation.
In order to move from “recycle-ready” to “recycled” and a genuine circular economy, Pharmaceutical and Medical Device companies, regulators and governments have to align and to proactively advocate for changes in the regulatory environment, and enhanced collection and recycling.
References and Data Sources:
WHO, Health-care waste key facts, 2018
OECD, Global plastic waste set to almost triple by 2060, 2022
US Environmental Protection Agency, 2022
Eurostat, Packaging waste statistics, 2023
Pharmaceutical Journal, Tackling pharmacy’s reliance on single-use plastics, 2023
Plastics Technology, Advanced Recycling, 2022
Healthcare Plastics Recycling Council, www.hprc.com
Various packaging company websites
Image Credits:
Amcor, Klockner Pentaplast, Südpack, Etimex, Huhtamaki, adapa, Superdrug UK
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