New Guidelines Offer Menu Of Standard Sterile Package Tests

The dye ingress test method continues to be a widely used test method for Container Closure Integrity (CCI) within the pharmaceutical industry. For high risk parenteral applications this method is not a suitable approach due to reliability of the method and measure. For applications with large molecule drugs or for pre-filled injectable container formats, the use of a dye ingress test method will simply not work. There is an active campaign to understand all the dynamics and implications of deploying a CCI test method. The transition to a deterministic test method for high risk CCI applications is a matter of common-sense patient safety. High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated. Packaging integrity can literally be a matter of life or death to an ailing individual. It can have a significant impact on the well-being of a manufacturer as well.

This is a major reason that many pharma and medical device companies are intensifying their package testing and enhancing their test methods. Visual spot checks performed by humans are being augmented or replaced by non-destructive quantitative test solutions, ensuring that the container closure system performs as needed. New test methods have been developed that generate quantitative data that can provide objective pass/fail standards for every package.