Solvent bonding
2024-10-04
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Medical devices account for almost a quarter of a hospital’s greenhouse gas emissions. How can we make them more sustainable?
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Repackaged!
Sustainable packaging solutions for the pharmaceutical industry
Packaging for pharmaceutical products, such as tablet blisters, pill boxes & bottles, is facing a new challenge: In addition to protecting their contents, sustainability is of increasing importance. In this article you can read about how this is achieved, which regulatory requirements to consider and what two industry experts say about the future of pharmaceutical packaging.
The basics: The environmental impact of pharmaceutical packaging
Pharmaceutical packaging, such as tablet blisters, must first and foremost protect their contents. In addition to protection against mechanical damage, chemical protection through high barrier properties is primarily intended. If, for example, oxygen or water vapour enter the packaging, unwanted reactions can lead to a change in the active substance and premature ageing. Apart from glass bottles and ampoules, the industry is mainly relying on fossil plastics such as PVC, PET or PP. And even traditional glass packaging is increasingly also addressed by special plastics such as COC – also based on fossil fuels.
However, the legislator has now set the regulatory lever on pharmaceutical packaging with the Packaging Directive, the Circular Economy Act and the Climate Protection Act.
The problem with today's blisters, bottles and co.: Production and disposal cause high CO2 emissions. And the combustion of PVC produces plant-destroying hydrochloric acid as well as dioxins such as TCCD. This makes disposal expensive – for clinics or the community. In addition, today’s packaging often consists of non-recyclable multi-layer films. Thus, they are not suitable for use in a circular economy or only for increased outlay and thus higher costs.
So how do we manage to develop packaging solutions that meet stringent regulatory requirements, are efficient and at the same time cost-effective and climate-friendly? Let's take a closer look at that.
Deepdive: The future of pharmaceutical packaging
Strictly regulated: What a pharmaceutical packaging must be able to
The regulation of pharmaceutical packaging in the EU is handled by the EMA (European Medicines Agency). The „Guideline on plastic immediate packaging materials“ are defined guidelines and requirements to which pharmaceutical packaging manufacturers must adhere. For example, they have to prove in extraction studies that no harmful substances get into the drugs from the packaging – so-called leakables and extractables. And that there are no interactions between the packaging material and the drug; this is proven in interaction studies.
The exact design of the packaging depends largely on the nature of the pharmaceutical product. Primary packaging for liquid vaccines, for example, must meet particularly high requirements. In the case of packaging for solid pharmaceuticals, a food approval, the designation of the polymer and the designation of attached additives after the European Pharmacopeia are often sufficient. In the latter standardized test methods and requirements for the established plastics are anchored.
Alternative (bio-)plastics may require a separate authorisation, but this is covered by the EMA.
In a nutshell
Pharmacopeia
Official reference book that sets standards and quality requirements for medicinal products and medical devices and serves as a guide for their manufacture, testing and use. It includes, among other things, standardized test methods and requirements for plastics.
EMA (European Medicines Agency)
The European Agency for the Evaluation and Authorisation of Medicinal Products in the European Union. Among other things, it establishes regulatory requirements and guidelines for the use of plastics in the pharmaceutical industry.
Recyclable pharmaceutical packaging is in demand
The EU's Packaging Directive puts pressure on:
The European Packaging Directive essentially states that the amount of packaging waste and its impact on the environment should be reduced. It also affects pharmaceutical packaging and calls for all packaging to be fully recyclable by 2030. An exemption for primary packaging in direct contact with the product only applies until 2035.
Recyclability must also be guaranteed here and recycling quotas must be met – in terms of the overall economy. There are some challenges. Composite films with a high water vapor and oxygen barrier, for example, are not recyclable or only difficult to recycle, since the different polymers have to be separated again.
What is clear is that new packaging solutions and materials are in demand, such as our bio-based MedEco XCD with extra high barrier power that surpasses PVC and PET. We have laid the foundations and are now open to pilot projects with customer!
In a nutshell
The Packaging and Packaging Waste Directive (94/62/EC), revised by Directive (EU) 2018/852, sets clear targets for recycling packaging waste and also sets specific recycling targets for different materials:
By 2025: 50% for plastics, 75% for glass, 85% for paper and cardboard, 80% for metals, 75% for wood.
By 2030: 55% for plastics, 80% for glass, 85% for paper and cardboard, 90% for metals, 85% for wood.
The proportions refer to the weight of the packaging waste.
Fig. 1: Upcoming regulation on the recycling quota in the EU Packaging Directive
#AskAnExpert
What do manufacturers of pharmaceutical packaging machines actually say about the future of packaging?
We asked KOCH Pac-Systeme GmbH what the pharmaceutical packaging of the future should be capable of:
The pharmaceutical packaging of the future must be smart and interactive. Integrated monitoring technologies will provide added security in the future and can take on additional functions such as monitoring medication intake. In the future, visual indicators will also give us information on the expiry date or contamination hazards. At the same time, it should meet ecological requirements and be fully recyclable. With the KOCH Packaging Competence Center and its more than 50 experts, we support customers holistically with these packaging requirements."
#MaterialMatters: The Composition of the materials is key
In a nutshell
ECHA
The European Chemicals Agency (ECHA) was established to promote the safe use of chemicals. Among other things, it manages the REACH-Systemgoverning the registration and monitoring of chemicals in the EU. The ECHA publishes a >>list of intentions and proposals to restrict critical substances. In this list you can monitor the progress of the test. Bisphenols and critical substances often used in PVC can be found here.
Critical substances in packaging materials
Pharmaceutical packaging today is almost always made of conventional plastics, mostly PVC, sometimes from PET, PP or PE. Polyvinyl chloride (PVC), for example, often contains plasticizers, and these are partly suspected to be toxic to reproduction. Polyethylene (PE) such as our MedEco XYI and polypropylene (PP) are usually physiologically non-critical. Here recycling is ambivalent: while mechanical recycling in monomaterials is very possible, chemical recycling in medical and pharmaceutically compliant is only inefficient compared to polyesters. This need not be a bad thing in the context of “downcycling” in large-volume industrial applications. However, PE and PP have a lower barrier effect than e.g. PET, PVC or MedEco XCD.
Due to possible regulation of substances of concern, for example by the ECHA, and the circular economy promoted by the EU, it is therefore already worthwhile to switch to polymers and formulas that are sustainable.
Monomaterials, Composite and Multilayer Systems
Packaging materials are often a combination of several of these plastics (see Figure 2). Such composite or multilayer films use several materials to combine different properties with each other. The goal is optimal protection of the content. There are two potential points of criticism: first, the potential danger to the user if critical substances are contained in the multilayer system. And secondly, it is difficult or impossible to recycle due to the complex structure.
We asked plastics expert Vinzenz Nienhaus what alternatives there are:
Very good and cost-effective alternatives are the bioplastics PLA and, in the medium term, PEF. We rely on these polymers for our MedEco XCB, XYI and XCD. They are not only very well suited for film production and blow molding processes, but also have a very low CO2 footprint, very good mechanical properties and very good recyclability. They are highly transparent and have very good barrier properties (PEF) or can be coated accordingly or used in composite systems (PLA). We offer these materials in medically safe qualities."
Vinzenz Nienhaus
Plastic expert & Co-founder of BIOVOX
The preferred solution: High-performance, recyclable packaging
Switching from conventional plastics to Bioplastics offers a future-proof alternative: bioplastics sometimes even have better properties.
For example, MedEco XCD has an increased barrier effect against water vapor and oxygen compared to PET, our materials often have higher mechanical strengths and have lower processing temperatures, saving energy in manufacturing. Our MedEco qualities meet the safety requirements for pharmaceutical products, are easy to process in today’s manufacturing processes – and at competitive prices. They consist of renewable resources, are circular and already save up to 85% of CO2 emissions today – with net-zero potential in the coming years.
In the various sections of this article, we have mentioned some guidelines, laws and regulations. In fact, there are a few more. We have summarized which guidelines directly affect or tangential pharmaceutical packaging in the following box:
In a nutshell
Overview of pharmaceutical packaging guidelines
The EU Packaging Directive: This Directive aims to reduce the environmental impact of packaging and promote the circular economy. >>More information
REACH regulation (managed by ECHA): The regulation is crucial for all chemicals manufactured or imported in the EU, including those in packaging materials. >>More information
EU plastics strategy(COM/2018/028): It is part of the European Green Deal and among other things, it promotes innovations in the field of recyclable and bio-based plastics. >>More information
EU guidelines on good manufacturing practice (GMP): These guidelines contain guidelines on quality assurance in manufacturing, including the packaging of medicinal products. >>More information
EU regulation on medical devices (2017/745): Medical device packaging has specific requirements to ensure that products remain safe and effective and do not cause harmful environmental impacts. >>More information
The German Packaging Act (VerpackG): This Act regulates the prevention and recycling of packaging waste and thus also the disposal and recycling of pharmaceutical packaging. >>More information
The European Green Deal: In healthcare, it aims to reduce the environmental impact of the sector and promote sustainable practices, such as the use of environmentally friendly and recyclable materials. >>More information
Circular economy action plan: This plan focuses on promoting a circular economy. For example, pharmaceutical packaging is designed to be easily recyclable. >>More information
Did you know? In addition to guidelines, there are also funding opportunities in the area of packaging. The European Green Deal Investment Plan (EGDIP) and the Just Transition Mechanism (JTM). >>More information
In a nutshell: The sustainable future of the pharmaceutical industry
The pharmaceutical industry, like all other industries, must reduce its environmental impact. One factor in this is the production and disposal of plastic pharmaceutical packaging. Until now, conventional plastics from fossil resources have mostly been used for this purpose. However, these have a high environmental impact and sometimes contain potentially harmful substances. The EU requires full recyclability by 2030 via the Packaging Directive and a drastically reduced CO2 footprint via the Climate Protection Act. With our MedEco bioplastics, we offer a solution for this combination: They are recyclable and have a reduced consumption of up to 85% Carbon footprint.
In order to remain competitive and forward-looking, it is in any case advisable to deal with the upcoming regulatory framework and more environmentally friendly alternatives at an early stage.
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