Westpak – Gross Leak Detection vs. Dye Penetration for Medical Device Package Testing

December 11, 2019 @ 10:00 am – 11:00 am


By Nicholas Tsellas

WESTPAK’s test professionals present a brief webinar comparing Gross Leak Detection and Dye Penetration as test methods for evaluating a Sterile Barrier System (SBS). We review the basics of ASTM protocols F1929 and F3039 (Dye), plus F2096 (Gross Leak) that describe the tests.

 We include an overview of the test equipment, images of test failures, plus the pros and cons of each test method. We offer our favorite test method for various device and package types, likely package defect causes, plus tips on how to avoid the defects contributing to or causing the failures.

What’s Covered:

•Brief overview of Gross Leak Detection (bubble) test per ASTM F2096
•Brief overview of Dye Penetration testing per ASTM F1929 and F3039
•Review of the test equipment, advantages and disadvantages of each test method
•Recommendations of which test type to use for various medical device and package types

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