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USP Class VI Medical Impact Plastics

  • From disposable plastic syringes and IV bags, to tubes and sterile barrier trays, use of plastics have played a significant role in the evolution of the healthcare industry. In fact, modern healthcare would look much different than it does today without the use of plastics and the wide range of products produced from plastic materials. As the healthcare industry continues to evolve, the versatile nature of plastic materials have allowed products to adapt along with this dynamic industry delivering benefits including sterility, quality, durability, and most importantly, safety for both patients and healthcare workers. The medical industry's commitment to both patient safety and sustainability is now driving new standards and innovations in packaging solutions.

    However, despite the many benefits, there are also unintended environmental consequences with single-use plastics in healthcare, namely the waste that they create. The Healthcare Packaging Recycling Council cited that over 32 billion pounds of healthcare plastics were produced globally in 2020, and this number was projected to grow to 48 billion pounds by 2025, most of which is being disposed in landfills or incinerated. However, 80-85% of this material is uncontaminated and non-hazardous, and therefore recyclable in theory. The impact of packaging waste on the environment is significant, highlighting the need for more sustainable practices in the industry.

    Faced with mounting public pressure and increasing environmental concerns regarding single-use plastic waste, stakeholders across the broader packaging industry are setting goals and targets to improve the sustainability of packaging solutions and the healthcare packaging industry is no exception. Sustainability in packaging design is becoming increasingly important for both the medical and pharmaceutical industries as they seek to balance eco-friendly practices with strict safety requirements. However, when it comes to healthcare packaging, this becomes a balancing act because while organizations set goals to deliver greater sustainability, product protection and patient safety must always take priority. As a result, the industry has been behind the curve when it comes to sustainability initiatives. But sustainability is no longer a trend and is essential for organizations to consider along with the stringent list of other specifications with patient safety as the top priority.

    The challenge then becomes, how do we design healthcare packaging in a way that delivers improved sustainability and recyclability, while continuing to prioritize patient safety and product protection?

The undertaking of implementing sustainable solutions across the healthcare packaging industry is a huge challenge, not just because of the stringent list of application requirements, but because of the industry’s dependence on single-use plastic products and the integral role they play in patient safety. The industry's reliance on single-use disposables creates significant sustainability challenges, as these products contribute heavily to waste streams and complicate efforts to reduce environmental impact. While true that these products generate a significant amount of waste, we cannot ignore the extensive list of benefits single-use plastic products provide from a patient safety perspective from reducing the risk of infection, to lowering the chance of cross contamination, and allowing for the delivery of life-saving medicines and medical devices to individuals across the globe. Ultimately, regardless of sustainability goals the packaging cannot fall short of serving its intended purpose or compromise on safety and regulatory expectations.

Choosing the right healthcare packaging material and design is therefore critical to ensuring patient safety, performance, sterility and effectiveness until the point of care - and any changes made in the name of sustainability must adequately balance all of these needs and requirements. The use of sustainable materials, including paper-based options, is being explored as an alternative to traditional plastics to reduce environmental impact and meet consumer preferences. Using the Three R’s as a starting point, medical device and healthcare packaging organizations can look at several viable strategies to meet sustainability demands without sacrificing critical specifications. In addition to performance, sterility, and effectiveness, packaging must also maintain the required shelf life of medical products while supporting sustainability and recyclability goals.

  1. Use innovative materials to enhance RECYCLING:

Design & redesign of packaging solutions using recyclable materials is key to delivering sustainable packaging in medical, pharmaceutical & healthcare packaging applications. Of course, this is easier said than done, as there are a list of concerns & specifications regarding safety, regulatory, packaging integrity, performance and compatibility with packaging & sterilization processes that must be addressed. In addition, medical OEMs may be hesitant to consider alternative materials due to the stringent specifications, no-change provisions and arduous qualification and validation process required for healthcare packaging materials. Recent innovations and development in sustainable medical packaging, such as new bioplastics and advanced recycling technologies, are helping the pharmaceutical industry and medical industry move toward more eco-friendly solutions.

While certain material solutions such as compostable packaging or glass may not hold up to safety and regulatory requirements for healthcare packaging, alternative plastic materials can provide enhanced sustainability without sacrifice to key requirements. Transitioning to a solution that is recyclable as well as compliant with all requirements & specifications can go a long way in helping organizations achieve their sustainability goals and targets, particularly when you consider that 85% of plastic waste generated from healthcare environments is non-hazardous, and could therefore be recycled if designed appropriately. The development of sterile medical packaging and sterile packaging that are both sustainable and compliant with ISO standards presents unique challenges and opportunities for innovation in the industry.

Looking at ways to reduce packaging complexity through the use of mono-material solutions can also contribute to improved recyclability. Ultimately, materials used in healthcare packaging were designed to perform a specific function, which sometimes requires the combination of multiple materials to achieve a desired specification that would extend beyond the capabilities of any one material. However, this is often-times in direct conflict with sustainability ambitions because combining materials can often render the packaging non-recyclable. Similarly, use of pigments and colorants can render the packaging non-recyclable depending on the polymer.

While much needs to be done to address the logistics of recycling within the healthcare packaging ecosystem, selecting materials with a favorable recycling outlook within the ever-changing system, as well as avoiding materials labeled as “problematic or unnecessary“ for recycling will increase the likelihood that packaging solutions will be recycled in the future. In addition, looking to organizations such as How2Recycle that provide guidance on the recyclability of packaging solutions based on a number of factors will give your packaging the best chance of being recycled at scale moving forward. For example, How2Recycle downgraded rigid PS (including HIPS).) to “Not Yet Recyclable” in 2021 following an assessment of the recycling volume in the US, viability of end-use markets and outlook for the material to be recycled at scale. While an excellent material from an efficacy and product protection standpoint, use of HIPS in medical packaging applications moving forward is in direct conflict with packaging sustainability initiatives. Therefore, transitioning healthcare packaging solutions out of HIPS into a material with a more favorable outlook for recyclability in the future including PP or clear PET could be the difference between millions of pounds of packaging being recycled in a closed-loop system versus sent to a landfill. Considering the arduous validation process for medical packaging, maintaining performance requirements of materials at all stages of the packaging manufacturing supply chain to the point of care, while meeting all requirements and specifications in between will be key.

Understanding the Life Cycle

The journey of medical packaging extends far beyond its initial design and manufacturing—it encompasses every stage from material selection and production, through use in healthcare settings, to its ultimate disposal or recycling. Understanding this complete life cycle is essential for medical device manufacturers and the broader healthcare industry as they strive to develop more sustainable medical packaging solutions.

The medical industry’s reliance on single-use packaging materials, while critical for maintaining sterility and patient safety, generates significant packaging waste. Much of this waste, particularly from pharmaceutical packaging and medical devices, is non-hazardous and could be recycled if designed appropriately. However, the need for strict regulatory compliance and uncompromising device performance often limits the adoption of alternative, more sustainable packaging materials.

To drive sustainability, manufacturers are increasingly adopting a life cycle approach—evaluating the environmental impact of packaging materials from sourcing and manufacturing to end-of-life management. This means considering not only the immediate function of medical packaging but also how material use, packaging design, and disposal methods contribute to the overall carbon footprint and environmental impact. For example, incorporating recycled materials such as high density polyethylene (HDPE) can help reduce waste and lower carbon emissions, while still meeting the rigorous standards required for medical packaging.

Innovation in sustainable packaging solutions is gaining momentum across the healthcare industry. Companies are exploring biodegradable materials like polylactic acid (PLA) as alternatives to traditional plastics, aiming to reduce the environmental impact of packaging waste. At the same time, efforts are underway to design packaging that is easier to recycle or even reusable in certain non-sterile applications, supporting the transition to a circular economy.

Collaboration is key to advancing more sustainable medical packaging. Medical device manufacturers, packaging suppliers, and healthcare providers must work together to ensure that new packaging options maintain patient safety and device performance, while also meeting sustainability goals. This includes developing recyclable, biodegradable, or reusable packaging designs that are suitable for healthcare settings and compliant with regulatory requirements.

Continuous improvement is at the heart of sustainable healthcare packaging. As regulatory standards evolve and consumer demand for environmentally responsible products grows, the industry is challenged to innovate and adopt more sustainable solutions. By embracing life cycle thinking and prioritizing sustainability at every stage—from material selection to end-of-life—healthcare companies can reduce packaging waste, minimize their carbon footprint, and contribute to a more sustainable future for the industry and the planet.


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