For decades, the medical device industry has relied on nylon-based forming films for the primary sterile barrier packaging of medical devices that pose a challenge to pack integrity—such as syringes, injection systems, catheter drapes, tubing and collection systems, filters, and many other devices.

Forming films contain nylon because it is a very robust and abrasion-resistant material. Nylon helps optimise overall pack performance and ensure device sterility is maintained through transit and storage. Nylon forming films are considered an industry standard, as they meet regulatory requirements and maintain medical device safety.

Taking action for more sustainable healthcare packaging

The World Health Organization identified in 2018 that 85% of waste produced by the healthcare sector is classed as non-hazardous, and like most household packaging, it could be recycled. It is an exciting opportunity for non-hazardous healthcare packaging to be effectively sorted and collected for recycling in hospitals. Amcor is currently working with HPRC (Healthcare Plastics Recycling Council)—a consortium of companies across the healthcare, recycling, and waste management industries—to help boost plastics recycling efforts in clinical settings. Amcor is also working with recyclers and other stakeholders to increase the acceptance of medical device packaging used by patients at home.

Providing more sustainable packaging options that meet the specific needs of the medical device segment is a difficult balancing act.

PE-based nylon structures have not previously been considered recycle-ready. Until today, the strategy to improve the sustainability of PE-based nylon thermoformed packaging focused on using thinner films, thereby reducing the packaging carbon footprint while being certain to maintain sufficient pack performance.

We now take these improvements to the next level. Following an extensive process involving many trials, our new Amcor HealthCare™ SureForm Pro Forming Films are now available in a recycle-ready option that offers the same high performance as our current solutions. The new film allows our customers to benefit from the reduced thickness of split nylon films, with the added benefit of being recycle-ready.

Read on to learn more about this latest offering from our product expert, Neil Hawkesford...

Q&A with Neil Hawkesford – Senior Product Manager

The product specifics

Q: Can Amcor HealthCare™ SureForm Pro Forming Films Recycle-Ready, deliver the same level of performance using the same amount of packaging material as current films?

A: Yes. Our new split nylon recycle-ready forming film structures are still PE-nylon based. This means both the standard and the recyclable versions deliver the same level of performance.

Q: Transport of medical devices requires quality packing materials to ensure proper protection. Can the recycle-ready versions of these films maintain pack integrity and sterility throughout transit?

A: When using the appropriate pack design for the device, both the recycle-ready and standard versions of our Amcor HealthCare™ SureForm Pro Forming Films will maintain integrity throughout the entire transit journey to the point of use.

Q: Can Amcor’s new recycle-ready split nylon forming films run on customers' existing machines and lines?

A: Split nylon recycle-ready forming film can be processed in the same way that standard nylon structures are and on the same packaging machines without requiring any alterations. The overall efficiency of your lines will be maintained.

How to make the switch

Q: What should medical device manufacturers consider when switching their packaging to a recycle-ready version?

A: There are many aspects that need to be critically assessed as part of this change. In many cases this can involve detailed revalidation. Our standard and recycle-ready versions of the split nylon films are aligned in terms of performance and generic film structure. This means that the risk of a significant difference in pack performance is low, and the approval decision can reference existing performance data for the current, standard split-nylon forming films. This should make the approval process significantly easier.

The sustainabilty benefits

Q: Has this innovation been certified as recyclable?

A: Yes. Institute cyclos-HTP is an external company specialised in the classification, assessment, and certification of recyclability of packaging and goods, as well as in research and development in this area. After analysis of our film based on sorting, processing and recycling capabilities in Europe, Institute cyclos-HTP certified our Amcor HealthCare™ SureForm Pro Forming Films recycle-ready version to be indeed recyclable.

Q: Which recycling streams is it suited for?

A: The recycle-ready option is labelled as class AAA+ when managed through the recycling path 1 for plastic films (LDPE) with a very high material recovery. When sorted through path 7, the mixed PO (polyolefin) flexibles stream, it is labelled as class A with high material recovery. Our recycle-ready split nylon films can be recycled in countries that have a PE film and/or mixed PO flexible sorting and recycling stream.

Q: How can Amcor support medical device manufacturers in becoming part of the circular economy?

A: Our new recycle-ready forming films can act as a step on the journey towards a more sustainable medical industry. The structure yields a high quality recyclate resin that better supports the transition to a circular economy when compared to alternatives on the market.

The cradle to grave environmental life cycle assessment Amcor HealthCare™ SureForm Pro Forming Films Recycle-ready was calculated in ASSET™, Amcor’s in-house life cycle assessment tool.The ASSET™ methodology is certified by The Carbon Trust.

The report compares our standard Sureform Pro film against our recycle-ready version and shows a 68% overall reduction in carbon footprint when we use the new recycle-ready version if it is recycled at the end of life.

Q: Where is Amcor’s split nylon recycle-ready film available?

A: Thanks to our expansive global footprint, we will be able to offer our range of medical forming films to any location. However, collection, sorting and recycling infrastructure for PE and mixed PO flexible pacakaging is implemented at different scales in the different European countries and globally. We can help advise customers on the recycling options availalble in different regions.

Q: Is this an industry first innovation?

A: It is the first PE based nylon medical forming film to be backed by a third-party recyclability certificate, and that doesn’t require changes to an established packaging process, while still delivering the same level of performance for high volume medical device applications.

Q: When will this new product be available?

A: Our customers can place orders now.

Contact us if you would like to discuss Amcor HealthCare™ SureForm Pro Forming Films Recycle-Ready option with one of our healthcare packaging experts.