Container Closure Integrity:A Holistic Strategy to Ensure Patient Safety

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