Ensuring container closure integrity (CCI) for vials stored at −80°C presents unique challenges, as cold temperatures can greatly impact the sealing mechanisms. This study introduces two methods using headspace carbon dioxide analysis to detect leaks in product-filled, frozen vials. By examining effusive and diffusive gas flow through defects, the research identifies the sensitivity of each method in detecting micrometer sized defect sizes.

Discover how these methods address the complexities of CCI testing for products requiring ultra-low storage temperatures.