Microbial Ingress No Longer an Effective CCI Test Method

Microbial Ingress No Longer an Effective CCI Test Method
In the realm of pharmaceutical sciences, ensuring the integrity of parenteral container closures is paramount to maintaining product sterility and safety.
The methods employed for container–closure integrity (CCI) testing play a crucial role in this process, influencing regulatory compliance and product quality assurance. At its core, CCI testing aims to prevent the ingress of contaminants into pharmaceutical products, particularly in parenteral formats where sterility is non-negotiable. Microbial-ingress testing was a practical mode for evaluating a container’s ability to maintain sterility. The integrity of a closure directly impacts the product's shelf life, efficacy and, overall, patient safety. Historically, the evaluation of sterility and CCI were tightly intertwined, and microbial-ingress testing was the gold standard to establish CCI and product sterility.
With the advent of new drug products, delivery systems and inspection technologies, the microbial-ingress test method has lost scientific relevance for CCI.