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.
Smithers Pira usually tests medical device packages for dye penetration in accordance with either ASTM F1929, ASTM F3039 or EN 868-1. ASTM F1929 is more applicable to porous material packaging such as Tyvek® pouches; whereas ASTM F3039 and EN 868-1 are more suitable for non-porous materials including foils.