ASTM F1929 - 15

Standard Test Method for Dye Penetration Detection of Leakages in Porous Medical Packages

Harmful biological or particulate contaminants can enter the medical package through leaks. These leaks often occur in seals between packaging components of the same or different materials. Leaks can also come from any hole in the packaging material.

The purpose of this test method is to visually observe the presence of leakage through paint leakage. This dye penetrating procedure only applies to individual leaks in a pack seal. The presence of a series of small leaks in porous packaging material that can be detected by other techniques cannot determine.

These procedures are suitable for confirming and locating leak sites. They are not quantitative procedures. No leak size can be detected from these tests. It is often used as a pass/fail test.

General test procedure:

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After a certain period of contact with the dye penetrant, the package is visually inspected for dye penetration.