What is Dye Penetration Testing?

The dye penetration or dye penetrant test involves injecting a sealed non-porous package with dye solution and then observing any capillary movement of the dye through the sealed area. Visual inspection is used to detect any defects.

Why Perform Dye Penetration Testing?

The dye penetration test is carried out to ensure the integrity of the package seal, thus ensuring the sterility of the contents of the package. With sterile barrier packaging in particular, dye penetration testing is used to detect seal leaks in porous medical packaging such as Tyvek®. STERIS adheres to the latest test standards in detecting seal leaks in porous and non-porous medical packaging by dye penetration.

Guidance Documents/Standards:

ISO 11607 – Packaging for Terminally Sterilized Medical Devices

ASTM F1929-15 – Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

ASTM F3039-15 – Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration



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