Westpak is certified to conduct product/package integrity testing to help guarantee successful delivery of products worldwide by any means of transportation.

Westpak is accredited to ISO/IEC 17025-2005, one of the most rigorous standards available for a mechanical testing laboratory.

Westpak is certified to the requirements of ISO 9001-2008 for quality management, and to ISO 14001-2004 for environmental management and sustainability efforts.

Dye Penetration Testing - ASTM F1929

dye-penetration

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