To enable a smooth transition from manufacturing to market, packaging, and sterilization of medical devices should be considered early.
FREMONT, CA: When a medical device manufacturer designs and develops an effective, safe, and reliable medical device that will positively impact care, it is essential to be keen it packaging and sterilizing. The product packaging and sterilization need to go through an extensive validation process. Regulatory authorities have stringent standards about how this is done. Packaging and sterilization are quickly expanding within the medical device industry. Both are vital to ensure that medical devices are contaminant-free, safe, and able to withstand several shipping and storage conditions. These markets are mature in their technologies and depend on long-standing and highly proven ways.
This approach is changing, and medical devices continue to get smaller and more daunting, including combination products that incorporate sensitive materials. The trend toward complexity makes it more daunting to completely sterilize these products with standard methods. As a result, accelerator-based technologies like electron beam and X-ray see the focus and investment like a complement to cobalt-based processing. Variants and alternatives to conventional EtO processing are also being created, like processing with EtO: CO2 mixtures and alternative sterilant gases.
Conventional products like Tyvek and nylon still dominate medical packaging materials. However, due to emerging regulations, OEMs are finding it problematic to stay with legacy sealing methods. Sealing continues to be a significant challenge for the industry and is one of the most crucial steps in the preparation and delivery process for a product. Once a package has been sealed, it must remain intact post-sterilization through delivery, transport, and shelf life, all the way to the point of use.
Design is vital for ensuring the packaging meets its purpose of protecting the device and maintaining the sterile barrier. Improper technique can result in weak seal flanges and the product's risk moving and creating a void in the seal, or perforating the barrier, whether it is a tray/lid combination or pouch. To streamline product development and speed to market, sterilization and packaging must be managed effectively in the design for manufacturability (DFM) process.