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.
Westpak continually upgrades and expands its equipment line-up. Therefore this list is a minimum of our capabilities:
(3) Dye Test facilities completely equipped