Amcor has today announced the European launch of an innovative 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 features and material structure.
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 barriers 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, which it says is a safer and simpler design. The new Amcor Dual Chamber Pouch uses a high-strength foil laminate that reportedly protects from light, moisture, and oxygen ingress to support shelf life and drug efficacy.
One side is peelable and allows aseptic presentation and 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 a 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 of R&D EMEA at Amcor, says: “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 minimize the ingress of moisture vapor into the pouch, we created a vent towards the centre of the inner film away from the seams.”