Amcor has launched a specialty multi-chamber pouch for drug-device combination products, which is available in Europe for the first time, and has already won a 2021 Award from the Flexible Packaging Association for its technical innovation and material structure.
Amcor has 10 specialist sites across EMEA dedicated to healthcare packaging innovation, and an established R&D and consultancy team focus focus on technology and growth. The company's newly launched Dual Chamber Pouch builds on years of experience across both medical and pharmaceutical industries to meet the complex requirements of medical device packaging.
Key features of the pouch include:
- A simplified packaging system for easier access to the device;
- Desiccant chamber to securely hold the desiccant sachet and eliminate any contamination risk;
- Amcor’s Rayopeel seal technology to provide an excellent clean peel for aseptic presentation;
- Multi-layer foil laminate to provide transit resistance and barrier to gas, light and moisture;
- Production in certified clean room with state-of-the-art inspection equipment; and
- 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 a 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, multi-compartment pouch with a breathable membrane separating the two chambers, in a safer and simpler design. It uses a high strength foil laminate, which 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 dessicant 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, which 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.
“To protect a combination sterile device with a therapeutic drug agent, we knew there were a lot of requirements to fulfil,” says Noemi Bertolino, vice-president R&D EMEA at Amcor.
“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 vapour 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 is currently only available in Europe from the company’s site in Sligo, Ireland.
All production operates inside a certified 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 Amcor’s customers.