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Integrity Testing

"Dye Testing of Packages to Evaluate Seal Integrity"

Can method FPA SPMC 004, Standard Test Method for Seal Integrity Dye Penetration Method be applied to the testing of blister/lid packaging?

Last Updated On April 16, 2008

Dye penetration is an excellent test for evaluating the seal integrity of blister/lid packaging. The dye penetration test should be validated using samples with a known channel size. One way to accomplish this is by sealing a fine wire in one seal of the blister/lid package and, after it has cooled, removing the wire. Care should be taken to develop a dye formula with color intensity sufficient to easily observe a channel.

When using water-based dye solutions, the amount of surfactant may need to be adjusted to provide optimal results (see the test method for the recommended range of surfactant concentration). As a general rule, nonbreathable packages (e.g. films and laminates) will perform best with the concentration of surfactant at the high end of the range. Whereas, a solution with a surfactant concentration at the low end of the range is appropriate for packages with at least one porous or breathable web (e.g. paper and Tyvek®). For further reference on testing porous packages see ASTM F1929 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection.

When using alcohol-based solutions, the alcohol choice must be compatible with the packaging material. The supplier of the packaging material can provide guidance as to the appropriate solvent choice.