Dye Penetration Test

Meaning of Test

Leaks observed indicate a defect great than 50 microns and would render a Sterile Barrier System unable to reliably maintain sterility. This test is also useful as a second opinion to leaks observed during Bubble Leak Testing in the seals of Porous materials that have been heavily folded. These folds can often create a concentration of bubbles which may falsely determined as a failure (refer to DuPontThis is not a whole package test in that it only accounts for defects in seals of packages.

Typical Range

Failures observed may range from heavy wetting of the dye solution in the seal, to outright draining of the solution through a large defect. The method is destructive to the Sterile Barrier System in that the operator must create a means to insert the dye. Furthermore, the dye solution will often soil or stain the device inside.

Associated Standards

Leak detection in primary package seals via dye penetration is commonly referenced by  ASTM F1929 - Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Test parameters that must be considered include the contamination of the product inside, as well as the suitability of the package materials to handle the dye solution.

Westpak most commonly recommends Dye Penetration Testing as a follow up to any gross leaks along seals observed during the Bubble Leak Test (ASTM D2096, http://www.devicelink.com/mddi/archive/06/01/003.html ). This subjective test can be difficult to conduct properly, Westpak provides hundreds of Dye Penetration Tests every year at our multiple locations.

What We Provide

Westpak provides thousands of Dye Penetration tests each year and has many Test Fixtures at our multiple locations to accommodate your next package validation.