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Additional Methods For Dye Penetration Test For Porous Medical Packaging

Two new dye application methods have been added to the ASTM F1929-12 Standard Test Method for Detecting Leaks in Porous Medical Packaging by Dye Penetration.


Committee worked on these additions for quite some time to ensure definitive inter laboratory study results. Additionally, some minor editorial changes were made to offer a better interpretation of the often misrepresented 5-20 second dye dwell time. The same dye solution formula is used with the same test method sensitivity of 50μm channels.


The edge dip technique is one of the additions. This method now is documented, standardized, and round-robin tested. It involves dipping the side of the porous pouch, bag, or tray into the dye solution and allowing for capillary action to pull the dye up, detecting a seal channel. Since it does not require a syringe for injection, it is safer, much less messy, and uses less dye solution.


The other technique uses an eye dropper or pipette to apply the dye solution to the outer edge of the package seal. This method is especially useful for lidded trays with a stepdown flange or when the seal is set back from the edge.


Users of the ASTM dye penetration test now have the flexibility of three proven and standardized methods to choose from when performing package seal integrity testing.