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About Packaging Combination Products (Medical Devices)?


Packaging materials for combination devices must support all regulatory and technical requirements that relate to sterilized medical devices and pharmaceuticals. In addition, the most notable combination products, drug-eluting stents, are expensive and delicate items. Their packaging systems must be protective, high performance, and have almost zero defects to make certain these sensitive products are efficacious in use. Obviously, these products have higher value than a syringe or an oral tablet. For that reason, medical-device manufacturers place stringent demands on combination-product-packaging materials and systems.

One of the biggest challenge is providing the required level of quality, which translates to reliability, ease of use, and surpassing rigorous package specs. Quality also refers to zero failures, especially zero defects in sterile barrier (sterility) properties of the package.

One bad package could make a $2,000 drug-coated stent unusable. Combination products are often used in high-risk surgical procedures so it is critical that the package provides absolute protection for the device. At the same time, packaging materials must open easily so the product can be aseptically removed.


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