Package Integrity Testing

Dye Penetration Testing is a destructive package integrity test that is applied to a transparent material that has been sealed to a porous material. A dye solution is injected into the package along the longest edge of the inner seal. Once the dye has been injected, a visual inspection is performed looking for channels of dye dispersed across the package’s heat seals. Potential defects within the seal of a sterile barrier system can then be visually assessed using this type of testing. There are three different dye penetration methodologies with Method A being the preferred testing methodology.

Method A – Injection: The dye solution is injected into the package along the longest seal edge and the seal is inspected for channeling or leaks.
Method B – Edge Dip: The edge of the package is physically dipped into the dye solution and then observed for any wicking upward for any channels.
Method C – Eye Dropper: After separating the two materials, an eye dropper is used to place a bead of dye solution along the outside edge of the package seal to detect a channel in the seal.

The ASTM standard used for dye penetration testing is ASTM F1929 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.