Holistic CCI strategy
•Container Closure Integrity (CCI)
–Introduction, Complex Regulatory Environment
•Container Closure Integrity Testing (CCIT) in the drug product (DP) life cycle
–CCS Qualification, Process Characterization/ Validation (Case Study 1)
–Holistic CCI strategy
Case Studies
•Case 2: Considerations for Frozen DP’s
•Case 3: Tightness of CSTD’s using He-Leak CCIT
•Case 4: He-Leak of PFS/Cartridges
