Amcor has launched a speciality multi-chamber pouch for drug-device combination products. Available in Europe for the first time, the Dual Chamber Pouch has already won a 2021 Award from the Flexible Packaging Association for its technical innovation and material structure.
With 10 sites across EMEA dedicated to healthcare packaging innovation, and an established R&D and consultancy team for continued focus on technology and growth, Amcor’s Dual Chamber Pouch builds on experience across both medical and pharmaceutical industries to meet the requirements of medical device packaging.
Key features include:
- Desiccant chamber to hold the desiccant sachet and eliminate contamination risk
- Amcor’s Rayopeel seal technology to provide a clean peel for aseptic presentation
- Multi-layer foil laminate to provide transit resistance and barrier to gas, light and moisture
- Production in certified cleanroom with inspection equipment
- 2D barcoding to ensure full traceability.
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 barrier against light, moisture and oxygen to maintain the stability and efficacy 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 first to allow the ETO (ethylene oxide) sterilisation process, and a secondary outer foil pouch with desiccant to preserve drug stability.
Amcor’s innovation is a single, multicompartment 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 efficacy. One side is peelable and allows aseptic presentation and easy access to the device. 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 field. 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, said: “To protect a combination sterile device with a therapeutic drug agent, we knew there were a lot of requirements to fulfil. The first 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 film 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 efficient, simplified design.”
Amcor’s Dual Chamber pouch will be available in Europe from the company’s site in Sligo, Ireland.
