Container Closure Integrity Test CCIT

Packaging development begins with the preparation of a product–package profile (e.g., user requirements specification), defining the proper product–package quality requirements and the package's maximum allowable leakage limit (MALL).

Taking into account these preliminary evaluations, the second phase concerns the choice of each package component's materials of construction, the choice of suitable component sources, and establish critical physical attributes and component dimensional tolerances.

The primary objective in package development and subsequent validation is to arrive at a quality product–package prepared using processes that reliably and consistently run within specified operating parameters as defined in the user requirement specifications, yielding critical package defects at a satisfactorily low rate.

The process validation through the CCIT is a mandatory step for the product manufacturing since evaluates the integrity of the packaging during the whole production process, by collecting the samples to be tested in specific steps of the process which have been highlighted as the most critical in the Risk Assessment.

After the process validation the CCIT should be moreover considered as a routine testing for the product batch release to evaluate potential failure in the manufacturing chain. The number of test samples in this phase can be usually significantly decreased with respect to the process validation phase.

Container–closure integrity tests have been recommended as alternative to sterility testing as part of commercial product stability programs. Validated package integrity test methods are usually more sensitive and reliable than standard sterility testing for detecting a breach in package integrity that could lead to sterility loss or failure in relevant product physicochemical quality attributes.

The transportation of the products is one of the most critical steps on which the CCIT has to focus the attention. The outer pressure variation depending from the variation in the altitude or the damage which could occur during transportation are situations that shall be considered in the Risk Assessment and properly justified in the testing strategy.