The dye migration test is used to determine the integrity of the package seal. This test involves injecting dye into the package and placing the weight of the solution against each portion of the seal for a specific length of time. The package is examined for evidence of seal failure demonstrated by dye slipping through the seal. This test method covers the dye migration test as defined in ASTM F1929. This test method conforms to the standard covered in ISO 11607 "Packaging for terminally sterilized medical devices".
Study Outline
A needle is inserted through the polyethylene surface of the package and the a dye solution is injected with a syringe. The package is placed into a vertical position so that the dye comes in contact with the seal. The weight of the dye solution is maintained against the seal for a specific amount of time. If a surfactant has been included in the dye, the weight of the solution is maintained against the seal for a maximum of 20 seconds.
If the package is exposed to the dye solution for a greater length of time, the wetting agent will cause the dye to wick through the package material. Evidence of water slipping through the seal is observed. The package is reoriented so that each portion of the seal comes in contact with the dye for the same amount of time. Evidence of dye slipping through the seals will be considered failure.
Sample Requirements
Minimum sample size: Complete package, no size restrictions
Recommended replicates: 11 test packages
Nelson Experts:
- Jennifer Gygi 801-290-7847, 800-826-2088
