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MedTech Outlook | Tuesday, March 22, 2022
Whether the sterilizing method or the barrier level is the primary consideration, packing requirements can be easily handled using various material options.
FREMONT, CA: While packaging is critical in various industries, few applications are as rigorous as those found in the medical device and diagnostic business. While the packaging for medical equipment may lack the flash and glamour associated with consumer items, package integrity is critical in no other situation. The package's purpose is to protect the product's sterility during its authorized shelf life and ensure its efficacy at the time of use. Today's outstanding array of flexible packaging materials contributes to achieving these goals. Some factors involving package selection are as follows:
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When a packaging system is required, numerous critical variables must be considered. These criteria will have a varying degree of influence on the material selection process. They should ideally be conveyed to the packaging supplier as early in the process as possible.
Methods of Sterilization: The first element to consider when selecting medical packing materials is the process of sterilization. Frequently, the packager is locked into a particular approach due to product constraints, process economics, or equipment availability. If end users are compelled to sterilize through autoclave, heat-resistant materials must be employed. Certain medical products are incompatible with specific methods of sterilization. For example, one would not use ethylene oxide (EtO) to sterilize liquids, such as filled IV bags, as this method requires permeable packing materials. When it comes to terminally sterilized products, the packager's options are frequently severely limited by the sterilization process chosen.
Level of Barrier: Another critical factor to consider is the required amount of barrier. Often, a product must be protected from oxygen, moisture vapor, or light. Along with preventing undesired parts from entering a package, it is frequently just as crucial to prevent critical product components from migrating out. Aluminum foil is a superb barrier material, and, as a general rule, foils with a thickness of 1 mil or more significant are virtually pinhole-free. Foil composites are available in formed as well as unformed configurations. Aluminum metalized films, which have a very thin aluminum layer on the scale of 100–200, are nonformable and are utilized to provide a lower barrier than foil at a lower cost.
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