Global demand for medical devices and pharmaceuticals is at an all-time high. The risk of degradation or contamination from mould and mildew-inducing moisture in the manufacture and transport of these items is an increasing concern within the life sciences sector. Georg Buchinger and Cora Helberg discuss how Constantia Flexibles' new alufoil container provides a solution.
Pharmaceutical devices are very vulnerable to outside factors; even the tiniest leak in the primary or secondary packaging material could lead to risks such as moisture ingress, which can degrade the API. To prevent hazards to patients in product failure, leak testing is commonly practiced in the device industry. Leak tests are also vital for preventing manufacturer liability, as quality standards have become increasingly stringent.
Following a demanding research and development programme, the pharma division of Constantia Flexibles Group recently introduced a breakthrough deep-drawn aluminium container, dubbed the Constantia Safemax, which offers a radical improvement from past technologies, providing new opportunities for containing and protecting a broad array of moisture-sensitive pharmaceuticals and medical devices.
When Constantia Flexibles developed Safemax specifically for use by a top-five pharmaceutical company, its engineers had to overcome several design challenges. Its clients face inviolable regulatory and health standards that require packaging to be hygenic, easily opened, protective against moisture ingress and commercially viable in the competitive global market. During the development process, the dedicated team of Constantia experts relied upon its technical understanding of aluminium as an effective packaging medium, along with the firm's well-established expertise in aluminium conversion technology.
Taking a systematic approach, Constantia Flexibles managed to resolve the most crucial issues in the product's development. In the process, the team realised a vision of a radically different pharma packaging system: during production, it can be tailored to perfectly match clients' individual product needs.
The Safemax production process differs for each customer. The development process begins when a potential client makes an inquiry and submits its requirements for an aluminum tray. Constantia then investigates which material is best for this application, and which features must be included in the alufoil container to meet a number of requirements. Typical considerations include:
Each of these aspects must be taken into consideration - with the client and the tooling maker - before any work can commence. A prototype of the container is then designed and produced as a 3D print. The client tests the 3D container print with the device, and then provides more information for optimisation. Upon implementing these alterations, the optimised alu-design is given to the client for approval. These samples are used by the client in transport, stability and shelf-life tests; upon passing the examinations, the material is approved by the client.
Safemax is very easy to open, due to its customer-convenient lidding foil, and highly transportable; but most importantly, it provides high moisture protection against ingress of moisture during global distribution. The final product meets the demanding quality, hygiene, regulatory and protection requirements for products in the modern healthcare market.