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
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.
* * * * *