DYE INGRESS, A POOR BET IN A HIGH STAKES GAME

Pharmaceutical industry continues to use the dye ingress method widely for container closure integrity testing. But, this method has been found inapplicable for high risk parenteral applications due to the reliability of the method and measure. For applications with large molecule drugs and for pre-filled injectable container formats, the application of dye ingress method is simply not effective. There is an on-going campaign to understand the dynamics and implications of using a container closure integrity test method. The preference of deterministic test methods over probabilistic methods for high risk applications is considered more apt for patient safety.