Cryostorage Bag CCI Challenges Solution

Container Closure Integrity (CCI) testing is essential for evaluating the biological safety of pharmaceutical packaging systems and ensuring contaminants do not migrate into drug products. As regulatory expectations from the USP and FDA continue to evolve, deterministic CCIT methods are increasingly preferred for their reproducibility, reliability, and reduced sample requirements compared to traditional probabilistic methods such as Dye Immersion and Microbial Challenge Testing.

Eurofins BioPharma Product Testing offers a comprehensive range of both probabilistic and advanced deterministic CCI solutions — including Vacuum Decay, Pressure Decay, High Voltage Leak Detection, Oxygen Headspace, and Helium Leak Detection — supported by more than 15 years of expertise across a wide range of packaging configurations and testing applications.