Amcor launches dual chamber pouch for drug combination devices in Europe
14 Jun 2021 --- Amcor is launching a specialty multi-chamber pouch for drug-device combination products in Europe.
The Dual Chamber Pouch has already won a 2021 Award from the Flexible Packaging Association for its technical innovation and material structure.
With ten specialist sites across EMEA dedicated to healthcare packaging innovation, Amcor says the pouch builds on years of experience across the medical and pharmaceutical industries, meeting the complex requirements of medical device packaging.
Key features:
- 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 provides an “excellent” clean peel for aseptic presentation.
- Multi-layer foil laminate to provide transit resistance and barrier to gas, light and moisture.
- Production in a certified clean room with state-of-the-art inspection equipment.
- 2D barcoding to ensure full traceability.
High-performance materials
Combination medical devices demand high-performance packaging materials to ensure the sterility and shelf life of the product.
Firstly, the packaging system must provide a barrier against light, moisture and oxygen to maintain the stability and efficacy of the Active Pharmaceutical Ingredients.
Secondly, the pack needs to be suitable for sterilization to deliver the device sterile at the point of use.
Amcor indicates these two opposing but critical requirements of breathability for sterilization 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) sterilization 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.
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.
Controlled environment
The internal breathable vent allows gas exchange for the desiccant to maintain a controlled environment within the pouch.
Meanwhile, the separate chambers eliminate any risk of the desiccant encountering the sterile device and sterile field.
A porous header using DuPont Tyvek is added to the pouch, providing an easy method of ETO sterilization, after which the pouch is sealed, the header removed, and the barrier pouch made ready for shipment.
Amcor has ten specialist sites across EMEA dedicated to healthcare packaging innovation. Its Dual Chamber Pouch won a 2021 Award from the Flexible Packaging Association.
“To protect a combination sterile device with a therapeutic drug agent, we knew there were a lot of requirements to fulfill,” reiterates Noemi Bertolino, VP 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 minimize the ingress of moisture vapor into the pouch, we created a vent toward the center of the inner film away from the seams.”
“This solution maintains shelf life and minimizes any risk of contamination. Our Dual Chamber Pouch complies with necessary medical and safety regulations in an efficient, simplified design.”
Healthcare packaging
Amcor’s Dual Chamber pouch will be available in Europe from the company’s site in Sligo, Ireland, which is focused on healthcare packaging.
All production operates inside a certified cleanroom and uses state-of-the-art inspection equipment for pouch making.
Individual barcodes can be assigned to each pouch for full traceability, ensuring the highest safety, quality and service standards.
In related news, Amcor recently launched an enhanced heat seal coating for medical-grade DuPont Tyvek 2 and paper applications in healthcare packaging.
In April, the global packaging giant also launched customer trials for its new mono-material, recyclable polyethylene blister packs in what it claims is a “breakthrough” for pharmaceutical packaging.
Edited by Joshua Poole
