FEATURE  Barcoding, Labelling & Packaging


Amcor launches new dual chamber pouch for drug combination devices in Europe


The award-winning and patented Dual Chamber Pouch provides a simplifi ed packaging solution for sensitive medical and drug combination devices.


F


or the fi rst time, Amcor’s speciality multi-chamber pouch for drug-device combination products is available in


Europe from the company’s site in Sligo, Ireland – which is 100 per cent focused on healthcare packaging.


With 10 specialist sites across EMEA dedicated to healthcare packaging innovation, and an established R&D and consultancy team for continued focus on technology and growth, the Pouch builds on years of experience across both medical and pharmaceutical industries to meet the complex requirements of medical device packaging. It is a simplifi ed packaging system for easier access to the device, with a desiccant chamber to securely hold the desiccant sachet and eliminate any contamination risk. Amcor’s Rayopeel seal technology provides an excellent clean peel for aseptic presentation, and multi- layer foil laminate provides transit resistance and barrier to gas, light and moisture. Production in certifi ed clean room with state-of-the-art inspection equipment, with 2D barcoding to ensure full traceability.


THE DESIGN CHALLENGE Combination medical devices demand high performance packaging materials to ensure the sterility and shelf life of the product. Firstly, the packaging system needs to provide


26 October 2021 Irish Manufacturing


barrier against light, moisture and oxygen to maintain the stability and effi cacy of the Active Pharmaceutical Ingredients (API). Secondly the pack needs to be suitable for sterilisation to deliver the device sterile at the point of use. These two opposing but critical


requirements of breathability for sterilisation and barrier pose a real challenge for packaging design. To overcome this, stents for example, are


typically packaged in two separate pouches, the fi rst to allow the ETO (ethylene oxide) sterilisation process, and a secondary outer foil pouch with desiccant to preserve drug stability.


THE SAFER SOLUTION Amcor’s innovation is a single, multi- compartment pouch with a breathable membrane separating the two chambers, in a safer and simpler design. The new Amcor Dual Chamber Pouch uses a high strength foil laminate, that protects from light, moisture and oxygen ingress to support shelf life and drug effi cacy. One side is peelable, the second non- peelable chamber houses the desiccant sachet or other scavenging technologies. The internal breathable vent allows gas exchange for the desiccant to maintain a controlled environment within the pouch. The separate chambers eliminate any risk of the desiccant encountering the sterile device and


sterile fi eld. A porous header, that uses DuPont Tyvek is added to the pouch, which provides an easy method of ETO sterilisation, after which the pouch is sealed, the header removed, and the barrier pouch is ready for shipment. Noemi Bertolino, Vice President R&D EMEA


at Amcor, says that to protect a combination sterile device with a therapeutic drug agent, there were a lot of requirements to fulfi l. “The fi rst objective was to create a pack design that was easy and intuitive to open and could be aseptically presented. The integrity of the drug’s effective dosage also had to be maintained. “To minimise the ingress of moisture vapor into the pouch, we created a vent towards the centre of the inner fi lm away from the seams. This solution maintains shelf life and minimises any risk of contamination. Our Dual Chamber Pouch complies with necessary medical and safety regulations, in an effi cient, simplifi ed design.” All production at the Sligo site operates inside a certifi ed cleanroom and uses the latest state-of-the-art inspection equipment for pouch making. Individual barcodes can be assigned to each pouch, providing full traceability, ensuring the highest standards of safety, quality and service are met for our customers.


Amcor www.amcor.com www.irish-manufacturing.com


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