Strategies to Evaluate Container Closure Integrity of Vial Systems

This case study by West Pharmaceutical Services explores strategies for evaluating the container closure integrity (CCI) of vial and syringe systems over varying time and temperature conditions. It discusses the use of multiple techniques, including helium leak detection and laser-based gas headspace analysis, to ensure systems meet maximum allowable leakage limits (MALL). The findings highlight the importance of proper characterization in pharmaceutical manufacturing to maintain product integri