Container Closure Integrity Testing (CCIT) Checklist (USP <1207>)

Program Scope and Method Selection

Define what is tested and why.

• Is a documented rationale in place for selecting deterministic CCIT methods over probabilistic methods where feasible? *
• Are all sterile container closure systems in scope identified, including vials, syringes, cartridges, and ampoules? *
• Is the maximum allowable leakage limit (MALL) defined based on product and microbial ingress risk? *
• Select the primary CCIT method employed. *
• Has CCIT replaced or supplemented probabilistic dye ingress or microbial immersion methods where justified?

Method Validation and Sensitivity

• Is the CCIT method validated with positive controls at or below the MALL using known defect standards? *
• Are laser-drilled or micropipette defect standards traceable and characterized for defect size? *
• Is method sensitivity, specificity, and the limit of detection established and documented? *
• Record the smallest detectable defect size validated for the method (microns).

Lifecycle and Sampling

• Is CCIT applied at appropriate lifecycle stages, including package development, validation, and stability? *
• Is CCIT used to support stability rather than sterility testing for closed containers where appropriate?
• Are worst-case conditions, such as freezing, shipping, and capping variability, challenged? *
• Is the sampling plan statistically justified for routine and stability testing? *

Documentation and Change Control

• Are CCIT results reviewed and approved by the quality unit? *
• Is CCIT re-evaluated when the container, closure, capping process, or product formulation changes? *
• Are failed integrity results investigated with product impact assessment? *