Update 01-Dec-2020: WESTPAK’s test laboratories are fully operational. Learn how we ensure everyone’s safety here. x

Dye Penetration Testing / Dye Leak Test

Dye Penetration Testing is an effective and widely used method of locating defects in pouch and tray seals. The test process places enough dye penetration solution into a package to create a 5mm deep well of dye along the seal’s inner edge. Defects and leaks in the seal area are observed by the test operator.

Detecting leaks and defects in a Sterile Barrier System or primary package of a terminally sterilized medical device package can be challenging. When properly applied (within the guidelines of ANSI/ AAMI/ISO 11607) leaks observed indicate a defect greater than 50 microns and would fail the criteria for a sterile barrier.

This test is also useful as a second opinion or verification to leaks observed during Bubble Leak Testing. Folds can often create a concentration of bubbles which may have been falsely determined as a failure.

Typical Procedures/Protocols

ASTM F1929
ISO 11607

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WESTPAK Capabilities

Westpak continually upgrades and expands its equipment line-up. Therefore this list is a minimum of our capabilities:

(3) Dye Test facilities completely equipped