Medical device packaging must allow its contents to be sterilized and then must maintain that sterility until the time of use, all while optimally balancing the multitude of considerations that are part of the package development process. Types include bags, overwraps, pouches, trays, and clamshells comprising a variety of materials, some flexible, others rigid.
Medical device packaging design is an integral part of delivering your device to market safely and securely, with the sterile barrier intact. Yet this critical process is often given little attention in the overall product development process. Most single-use sterile medical devices can be opened with a high degree of confidence that the product has maintained sterility throughout the product lifecycle, yet getting to this point can prove troublesome.
Whether as foil or medical tray, aluminum is a barrier against light, oxygen and moisture. Those properties are in increasing demand, owing to the growth in medical devices that incorporate pharmaceuticals and biologics.
Rigid medical thermoform
KOSBEST specializes in the design of creative, precision-manufactured thermoformed trays, blisters and clamshells. Our light-gauge protective thermoforms are produced with tight tolerances, excellent clarity and high impact resistance for the most critical applications from simple non-sterile to more complex double sterile barrier packaging systems with quality built into every step.
Our protective packaging components from BargerGard pouches, lids and void fill to custom, die-cut lidding and mounting cards are provided as parts of a complete, turnkey packaging system designed to protect products until final point of use. All of our sterile packaging products are clean room manufactured in our multiple ISO certified environments.
Adhesives and coatings
A medical device package that has a poor heat seal is unlikely to deliver its contents in a sterile state. Since the majority of heat seals on medical device packages are the peelable variety, as opposed to permanent, the challenge is to strike the optimal balance between bond strength and ease of opening. An associated concern is a clean peel, meaning that the separation of the surfaces does not result in particulates that might compromise sterility.
The variables affecting the integrity of a heat seal are pressure, temperature, and dwell; that is to say, two surfaces are held together (pressure) for a specified time (dwell) while heat (temperature) is applied. Whether the heat seals involve form/fill/seal or magazine-dispensing, high productivity is an objective. Dwell needs to be as short as feasible, pressure needs to be as low as feasible, and temperature needs to have the widest range as possible──quite the balancing act for whatever formulation that is tasked with achieving acceptable seals under acceptable production rates.