Dye Penetration

Dye penetration testing is used to determine the integrity of the package seal in accordance with ASTM F1929 (porous materials) or EN 868-1 (non-porous materials).

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.

Smithers Pira commonly 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.