Sartorius, Global Plastics Group,
Keywords: plastics ageing, medical devices, sustainability
Summary:Plastics are sophisticated materials that start their life span as soon as they leave the mould cavity. Their properties are dependent on time, temperature, and load, making them very similar to live organisms. It is essential that plastics manufacturers understand and appreciate their behavior to attain valid product life spans and improve their sustainability. It is a challenge in the biopharma industry to establish appropriate qualification protocols for single use devices that may need storage before their functional lifetime starts. In other words, every product completes its unique journey before it can be used at the end-customer. At this point, the manufacturers need to provide a quality certificate that guarantees the device's safety and robustness throughout its life cycle. Likewise, package material ageing information is needed to ensure package integrity, satisfy FDA validation requirements, and provide evidence of sterility and fitness for use over a product's life cycle. To do this the healthiest way, the manufacturers need to build their own materials libraries where they study each specific polymer’s ageing behavior under various factors such as constant load, temperature, and environment. This information will enable attain a valid and reliable qualification protocol. With appropriate materials data, very often the life span of the product can be extended to also improve the sustainability of the devices. Here in this presentation as Sartorius we will be challenging using polymers’ ageing knowledge as a measure to attain healthy life span for the end products while at the same time improving their sustainability.