Update 07-July-2020: WESTPAK’s test laboratories are protected and fully operational during the pandemic. Learn ways we ensure everyone’s safety herex

Dye Penetration 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

More Information

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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