A needle is inserted through the polyethylene surface of the package and the 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.
Please see our
Packaging Validation matrix for more information.
“My experience since switching to Nelson Laboratories has been excellent. Their customer service, technical assistance, and having my test reports available on line, provide me the confidence, dependability, and control of my routine testing and special projects that was just not obtainable with my former test lab. I have enthusiastically recommended Nelson Labs to my colleagues and will continue to do so.”
Rod , Quality Assurance Manager , Medical Device Manufacturer
Package Testing
Nelson Labs performs dye migration, seal peel, burst, and bubble emission package testing.
Minimum sample size: Complete package, no size restrictions
Recommended replicates: The number of test packages that are needed for this test are at the discretion of the sponsor. However, Nelson Labs recommends that at least 11 test packages be tested to make sure that the test is statistically significant.