Medical device package integrity test methods: 2018

With links to 13 ASTM integrity test methods and insights from 16 medical packaging experts, this report discusses minimum hole size, sensitivity levels, repeatability and validation.

Lisa McTigue Pierce, Executive Editor

August 27, 2018

1 Min Read
Medical-packaging-OR
Medical packages must be tested to assure the sterile barrier has not been breached. But which test is best?Shutterstock images

If you are responsible for testing the integrity of sterile barrier systems for medical devices, this free 25-page definitive guide is for you. Written by veteran medical packaging journalist Daphne Allen, it outlines the available package integrity testing methods, along with exclusive research on the most-used tests.

It’s a great review, especially to prepare for the upcoming meeting of ASTM Committee F02 on Primary Barrier Packaging, scheduled for Oct. 3-4 in Nice, France.

With links to 13 ASTM integrity test methods and insights from 16 medical packaging experts, this report discusses minimum hole size, sensitivity levels, repeatability and validation.

Also, results of the Pharmaceutical & Medical Packaging News exclusive study reveal:

• Challenges in package integrity testing—and how they are being solved.

• Whether the current tests meet industry needs.

The report looks ahead, too. With the future involving combination products—that is, medical devices with a pharmaceutical product—what changes might be coming in package integrity test methods?

Download your free copy now.

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About the Author(s)

Lisa McTigue Pierce

Executive Editor, Packaging Digest

Lisa McTigue Pierce is Executive Editor of Packaging Digest. She’s been a packaging media journalist since 1982 and tracks emerging trends, new technologies, and best practices across a spectrum of markets for the publication’s global community. Reach her at [email protected] or 630-272-1774.

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