Key Considerations For Pharmaceutical Packaging: Determining The Limit Of Detection In CCIT

By Oliver Stauffer

Ensuring container closure integrity is critical for maintaining pharmaceutical product sterility and meeting regulatory standards. Deterministic test methods, such as helium leak detection, MicroCurrent HVLD, and vacuum decay, offer precise and reproducible results, but their effectiveness hinges on understanding the limit of detection (LOD). LOD defines the smallest defect size a method can reliably identify, and factors like drug product interaction, defect geometry, and test sensitivity all play a role. Laser-drilled positive controls are widely regarded as the gold standard for validating CCIT methods, yet even these have limitations when defects fall below 5µm. With evolving USP guidance and stricter expectations for validated deterministic methods, pharmaceutical companies must demonstrate due diligence in selecting and validating the most appropriate approach.

Explore how to navigate these complexities and align with regulatory requirements.