Package Integrity is the absence of gaps/breaches in packages that could risk product quality by allowing contaminant ingress and/or product loss. Although parenteral packages must keep products sterile, package integrity is not defined as absence of microbial or liquid ingress nor product sterility. As per the proposed revisions to the USP <1207> guidelines, sole reliance on ingress tests (bubble testing, microbial and dye ingress) to confirm Container Closure Integrity (CCI) is not recommended since ingress is a probabilistic event which is difficult to control, predict and measure.
Package integrity verification requires careful examination of package leakage given the specific product and its life cycle. Cryopak Testing Center’s Container Closure Integrity division is privileged to offer the pharmaceutical and biotech companies along with their respective medical device manufacturers with the most recent deterministic capabilities. Our experienced scientists; dedicated to CCI and the full range of methods; develop, validate and execute Container Closure Integrity Testing (CCIT) methods. We can provide tailored expertise to design and execute a CCI study based on your system, providing the support you need.
CCI method selection depends upon the container system being evaluated; a single method is not suitable for all systems. Cryopak Testing Center can help. Let our experts assist with the determination of the right test method for your system.