Microbial Ingress No Longer An Effective CCI Test Method

By Oliver Stauffer and Tyler Harris, PTI

Microbial ingress testing has long been considered a standard for container closure integrity (CCI), but evolving scientific understanding and regulatory expectations reveal its limitations. This method, which relies on detecting microbial contamination as a proxy for closure integrity, is inherently variable and lacks the sensitivity required for modern risk-based quality assurance. Factors such as microbial behavior, environmental conditions, and test reproducibility introduce uncertainty, making it an unreliable indicator of true CCI performance. Today, advanced deterministic methods offer more precise, validated approaches that align with regulatory guidance and industry best practices. Transitioning away from microbial ingress testing is critical for ensuring product sterility and patient safety.

Explore why this shift is necessary and what alternatives provide robust, science-driven assurance.