Dye penetration / Seal integrity testing

Dye penetration testing is used to determine the integrity of the package seal.

The dye penetration test involves injecting a dye solution including a surfactant into the package and allowing it to contact each seal for a specific time. The package is examined for evidence of seal failure evidenced by dye penetrating through the seal.

Pira usually tests medical device packages for dye penetration in accordance with either ASTM F1929 or EN 868-1. ASTM F1929 is more applicable to porous material packaging such as Tyvek® pouches; whereas EN 868-1 is more suitable for non-porous materials including foils.

In cases where the material is not transparent the pouch is dried after introducing the dye, then peeled open and examined for dye penetration.

Expert Profile

  • Doug joined Pira in 1989 and has 20 years experience in the physical testing of packaging and packaging materials. He heads a team specialising in packaging and print related technical investigations. In 2004 Doug gained his postgraduate degree with distinction in Packaging Technology from Brunel University.

    Doug Leatherdale
    Doug Leatherdale

    Head of Physical Testing

    Pira International

    +44 1372 80 2108

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