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Materials for Medical Device Packaging

Here’s a roll call of the major materials that go into medical device packaging.

Sterling Anthony, CPP, is a consultant specializing in packaging, marketing, logistics, and human-factors.
Sterling Anthony, CPP, is a consultant specializing in packaging, marketing, logistics, and human-factors.

This article is in follow up to a recent article, “Sterilization methods for medical device packaging."

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.

Paper

Today’s medical-grade paper provides the benefits of earlier versions, plus certain improvements. Paper, since it’s made up of fibers, can generate particles when the package is opened, which can compromise sterility. That issue has been addressed by impregnating the paper with a polymer, latex, for example. The result is a clean peel, so highly valued in pouches and in lidding.

Polymer impregnation does not sacrifice the porosity required by sterilization by steam or by ethylene-oxide (EtO); in addition, impregnation contributes against later contamination by denying microorganisms direct surface-to-interior pathways.

Tyvek®

A DuPont brand, Tyvek is marketed as an alternative to medical-grade paper. Tyvek is a polymer, HDPE, in fact. It’s made up of long, spun filaments, randomly laid and bonded into sheet form by heat and pressure. The random, pressed-spaghetti composition results in a material that is porous yet provides an effective barrier against microorganisms.

Unlike paper, Tyvek is devoid of fibers, its clean-peeling characteristic not dependent on additional treatment. Continuing the comparisons with paper, Tyvek is more resistant to tearing and puncturing.

Aluminum

Whether as foil or vacuum-deposited on film, 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.

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