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Medical device package testing case study

Defining test inputs, material selection, and machine compatibility are among the significant factors to consider in medical device packaging.

Device testing
Device testing

Say you’re a packaging engineer and your package-testing mission involves a surgical device made of high-carbon steel that’s corrosion-prone, requires gamma radiation, must work with current thermoform/fill/seal machinery, offer a five-year shelf life, and be cost-effective.

What do you do? A good first step would be to check the regulatory framework, particularly ISO 11607-1 and 2, as well as FDA quality system regulations for medical devices. That was a recommendation from Karen Greene ([email protected]), Life Packaging Technology, LLC, a customized packaging engineering services firm. Greene discussed this case history during a Webinar Nov. 15, entitled, “Developing and Validating Barrier Shelf Life for Medical Device Packaging,” presented by the Institute of Packaging Professionals and sponsored by Healthcare Packaging.

In this anonymous medical device packaging case history, Greene recommended ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products as “a nice compendium on barrier test methods.” Among the takeaways from the Webinar were the following:

• Understand your process details. Verify flat film permeation results, and perform an analysis of film machinability on the equipment on which it will run.

• During the package development process, companies need to clearly define the project objective, obtain a corporate buy-in on documented design inputs, and define the resources that will be necessary to achieve their goals.

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