Whether acting in an advisory capacity, or discussing with a new client for contract laboratory work, it is entirely common to receive the following request:
“I need a CCI method (or vacuum decay method, helium method, headspace method, etc) for my product.”
However, this phrase almost never accurately reflects the need of the individual, the product-package system, or the organization. CCI method selection is entirely dependent on the requirements and limitations imposed by the product, the package, and the study goals to be assessed. Further discussions yield more information regarding why there is a need for CCI testing, such as:
“I need to implement a CCI test for stability samples.”
“I need to prove that my new package system is equivalent or better than the existing system.”
or, more simply,
“I need to ensure that the product-package system meets all relevant CCI regulatory expectations.”
Even in each circumstance above, the potential solutions are myriad. In each and every case, CCIT is a custom test program. Failure to consider it as such is failure to understand CCI holistically. Understanding the complex inter-workings of regulatory requirements and guidance documents, product-package limitations, CCI test options, and broader control and risk mitigation strategies is paramount. While CS Analytical lists the types of technologies available, the ability to integrate these technologies into a comprehensive package directly addressing concerns is the true value-add. CS Analytical maintains a state-of-the-art CCI laboratory with all relevant technologies not simply to offer clients the choice of an instrument, but rather to be able to leverage all equipment necessary to ensure client success.
- Evaluation of package performance at cold and ultra-cold storage conditions. Elastomeric materials are known to reach glass transition around -60° Storage below these temperatures risks leakage that is otherwise not present at ambient conditions.
- Capping studies intended to identify ideal capping conditions for vials or cartridges, evaluating the impact of sealing parameters and component dimensions on leak rates. This is immensely valuable in package development and assembly validation, but not as relevant for final product testing, on batch release, stability, etc.
- Alignment of multiple test methods of varying sensitivity across a product-package’s lifecycle. This is applicable to many product-packages, but autoinjectors are a prime example. Testing the final, filled, and in-device injection system to any reasonable level of sensitivity relative to defects of concern is notoriously challenging. Breaking the product-package down into different stages of assembly, verifying integrity as complexity increases, is key to both fully characterize the system from an integrity perspective, but also to meet regulatory expectations for leak test sensitivity.
CS Analytical consists of founding members of the world’s first cGMP, FDA-registered contract CCI laboratory housing all deterministic technologies as listed in USP <1207>. The resulting laboratory set standards and best practices for industry still used today, many of which are directly incorporated into USP <1207>. CS Analytical is the most trusted source for designing and implementing a comprehensive container closure integrity strategy to industry best practices that reduce organizational risk and exceed regulatory expectations.