New advanced extrusion technology for medical devices

As the new medical device regulation (MDR) looms, medical device manufacturers (MDMs) intensify their focus on packaging to have full confidence that the packaging supports the reliability and usability of their sterile devices at the point of use.

To support this, Amcor have invested over €10 million in our Centre of Excellence for cast films in Bristol, UK, with a state-of-the-art 11-layer cast extrusion line, along with integrated slitting and packing machinery capable of processing a range of different polymer types. Read on to follow the journey taken to develop this technology, and how Amcor is now able to deliver even more robust packaging solutions for their medical device customers.

The need for durable, transit-resistant medical device packaging

Amcor recognizes the need to progress in line with our customers and that MDMs are looking for higher performance packaging that increases their confidence in maintaining device sterility.

After initial production, most medical devices are directly packaged, before being loaded into distribution boxes, sterilized and shipped all over the world. During this extensive supply chain, there is risk that the packaging can be damaged, for example as boxes are dropped or shaken, which can ultimately result in the sterility of the product being compromised, rendering it unsafe to use. The consequences of packaging damage are extensive and can in extreme cases impact the health of patients. In the event of packaging damage, brands may also be subject to investigations from the regulator, unannounced audits or having to take a product off the market until the regulator can be assured of safety and reliability.

Compromised packing can cause general frustrations also for healthcare providers both in terms of time and money wasted when the product is deemed unusable. Over time this can lead to the loss of brand reputation and confidence.

Focusing on thermoformed packs

To understand the challenge for these thermoformed packaging materials, extensive testing in our own labs and in independent facilities was undertaken to replicate the transit stresses the packed products will experience. The result was the decision to invest in new state-of-the-art technology, allowing us to produce 11-layer films with innovative processes and control systems to ensure product performance and quality. These films include high performance Nylon forming films for challenging medical devices; delivering the high transit resistance needed by MDMs.

Consistency, sterility and durability – Amcor’s Advanced Cast Extrusion Technology

By introducing multi-layer cast extrusion technology, Amcor have been able to develop higher performing packaging that will ensure the integrity of the product to the point of use and aid the efficient administration of the device, protecting patient safety.

The new production line means we can continue to meet the growing quality demands of customers, resulting from ever-challenging regulatory requirements. Consistency is key for MDMs and through our precision processes, the new cast extrusion technology offers packaging films with repeatable and reliable thermoforming, sealing and mechanical properties to ensure device sterility and usability.

In addition, the integrated slitting and packing line eliminates manual handling of reels and fully seals reels into a bag to ensure cleanliness, thereby minimizing contamination risk and bioburden – a key need for all MDMs.

Find out more about our new film families from our Advanced Cast Extrusion Technology, such as DS-X, and BNE-X.

Watch our video to learn more about this new technology and how it can support your medical device packaging journey.