The Container Closure Integrity Testing (CCIT) concern the techniques to control the integrity of a closed container, that contain a product, as for example a pharmaceutical product.
Integrity definition: a compliant container does not show any discontinuity on the surface that divide the outer part from the inner part of a container. Consequently, the definition of leak is a detectable and measurable access possibility between the outer and inner part when the container is closed.
The aim of the integrity control has been generated by two essential needs:
- The protection of the product from the potential contaminant agents coming from the external environment.
- The protection of the environment and the operators from the effects of powerful pharmaceutical products leaked from the container.
The product protection.
The contamination of a product caused by the unexpected contact with the outside can have different nature:
Chemical: Oxygen (for products packed under inert gas because these are sensitives to oxidation)
H2O (Humidity) for dry product that can spoil.
Biological: Microorganism that can deteriorate the product and be dangerous for the patient, above all in case of injectables, ophthalmic products, etc.
Particulate: Leak in the integrity of the closure can be rarely the cause of a contamination from external particles, that more often is caused during the filling or by particles released by container itself.
Protection of Environment, operator, and patient.
The risk of unexpected release of pharmaceutical products with high biological activity is a threat for
Environment: for the subsequent contamination of living being, but also for the potential cross contamination of the pharmaceutical production premises.
Operators and patients: because they can be exposed to the product.
Clearly, the detection of leaks or alteration of the product after its distribution can cause a series of negative effects as product recall, investigation of the production and control processes, etc.
When leak is a problem: The leak is critical only when has negative effects? NO.
A detected leak in a container is an issue itself and must be avoided.
