Package Integrity Tests

Toluidine Blue Dye Leak Test

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Packages may be tested for integrity (holes, channel seal leaks, open seals) by inserting a Toluidine Blue Dye solution with a specific viscosity. This method has been shown to detect openings as small as 50 microns. It is suitable for packages made from clear film sealed to non-woven material. It may be used for some clear film/paper packages but care must be taken to separate package failures from wicking.

ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Under Water Bubble Test

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ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

Vacuum Test

ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission