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Packaging: Dye Migration Test

Packaging: Dye Migration Test

The Dye Migration test determines the integrity of the package seal and enables manufacturers to see if there are channels that leak in the pouch seal. This test is designed to be conducted on porous packaging with a clear side. For double and triple packaging configuration, each article should be tested individually. Nelson Laboratories performs this test in compliance with ASTM F1929 and ISO 11607 “Packaging for terminally sterilized medical devices” and we are actively involved in the ASTM committees.

Applicable Standards

  • ASTM F1929
  • ISO 11607

Test Options

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PKG250 Packaging: Dye migration, ASTM F1929, per pouch Add
PKG250 - Packaging: Dye migration, ASTM F1929, per pouch

Study Outline

In the Dye Migration test, 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.
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