Determining the best approach for your Container Closure Integrity Testing needs

Lenn Harris, Manager of Chemistry and Container Testing, Eurofins Medical Device Testing

Container-Closure Integrity (CCI) is critical to ensuring that the quality and safety of marketed drug products are stable throughout the shelf life of the material.

Per the USP, “It is not practical to require that packages be absolutely leak-free. Rather, it is the significance of the leakage in relation to product quality that needs to be considered.” Basically, this means the container-closure system needs to contain the drug product and stop ingress of harmful materials such as microorganisms, contaminants and possibly gases from manufacture to the end use of the product.

In 2016, the USP issued guidance that deterministic methods should be examined in place of older probabilistic methods such as dye ingress or microbial ingress.

Deterministic methods can detect smaller defects more effectively and reliably in the container closure system than the older probabilistic methods.

The choice of an appropriate deterministic method is critical to the success of measurement in CCI in a system. Each technique has its advantages and disadvantages that must be considered as a method is chosen. Multiple technologies are mentioned in the USP for testing CCI.

While the USP does list technologies that can be used, there is no specific method in the USP <1207> monograph. There is no single method/technology that can be used for all testing.

Each product/closure system configuration needs to go through the process of proving that a specific technique can detect leaks at an appropriate level.

The Eurofins team is able to help you determine the best approach for your CCI testing and execute the development and validation of appropriate methods.