Evaluating The Container Closure Integrity Of A Vial Using Headspace Gas Ingress Methods

By Allison Alix, Application Scientist at Lighthouse Instruments

To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use. Proper packaging prevents ingress of contaminants, including microbes and degradational gases, that can potentially alter the properties and functions of the drug. Unfortunately, these contaminants are not always visible to the human eye, and auxiliary tests, known as container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.