Case Study: CCI Test Method Validation for Prefilled Syringes

Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. For detection of CCI defects at the plunger seal of a pre-filled syringe, using an FMS Headspace Gas Analyzer and a CCI Test Vessel has been validated as an accurate and reproducible method.

In this Case Study, learn more about the method that was developed and then validated for detection of CCI defects at the plunger seal of a pre-filled syringe.