For the pharmaceutical and medical device sectors, the choice of test method is often dictated by regulatory guidance such as FDA CFR 21 Part 820 or ISO 11607 (Packaging for terminally sterilized medical devices).
The test is simple in concept but rigorous in execution: A flexible package is submerged in a liquid (usually water or a surfactant solution) while a vacuum is applied. If the package leaks, bubbles will stream from the defect point. This is commonly known as the or "water immerson test." astm d3078 pdf 2021
ASTM D3078-02(2021) is the established, cost-effective standard for visually detecting gross leaks in flexible packaging via bubble emission, widely used across food and medical industries. While offering simple, non-destructive testing, the method is subject to operator interpretation and may not detect fine leaks. Purchase the official standard at ASTM International Store . For the pharmaceutical and medical device sectors, the
To perform a test compliant with ASTM D3078 , specific apparatus are required: This is commonly known as the or "water immerson test
If you cannot use the bubble method, consider these ASTM alternatives:
Locating small breaches in the material itself.