The importance of leak detection in finished sterile containers cannot be overstated. Undetected container-closure defects can compromise the sterility of parenteral medicines, posing a significant risk to patient safety. Often invisible to the naked eye, these defects can be elusive but are more likely to occur—or even transiently appear—as the storage temperature decreases. The webinar shed light on why storage temperature is a crucial factor in validating a CCI method and how it impacts the physical properties of the container and its components, particularly when stored at deep cold or cryogenic temperatures.
The session also reviewed the foundational understanding of USP <1207>, a standard that recognizes several deterministic technologies for CCI testing, including Laser-based Headspace Analysis (HSA). HSA has emerged as an especially useful tool for validating the integrity of containers made from glass and polymers and stored under diverse conditions, including extremely cold temperatures. However, several nuances must be considered when designing, developing, and validating an HSA-based CCI method, and the webinar aims to navigate these intricacies effectively.
The brief overview of USP <1207> set the stage for a more in-depth discussion on how a laser headspace method can be validated in accordance with a product’s storage temperature. This was followed by practical examples and guidance on utilizing a validated HSA CCI method for various applications. From assessing the shelf life of containers to optimizing and validating filling lines, and even conducting shipping studies, the webinar provided a comprehensive resource for professionals in the pharmaceutical industry and offered a detailed and informative guide to mastering CCI at various temperatures.
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