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. In this Case Study a method was developed for CCI testing of pre-filled syringes and then validated.

Download this Case Study to learn more about the validation of CCI testing methods, in particular for prefilled syringes.