There is a critical need in the pharmaceutical industry to perform leak detection testing on finished sterile containers. Container-closure defects pose a critical loss of sterility in parenteral medicines, which may affect patients adversely if not discovered. Container-closure defects are often hidden from view and are not easily detected by visual inspection. Although container-closure defects may occur infrequently, their occurrence becomes more probable and even transient as storage temperatures decrease.
Storage temperature is one of the most critical factors to consider when validating a CCI method. Temperature can dramatically impact the physical properties of the container and its components, especially when containers are stored at deep cold or cryogenic temperatures. Laser-based Headspace Analysis (HSA) is one of several deterministic, container-closure integrity (CCI) testing technologies acknowledged in USP <1207> that is suitable for detecting leaks in sterile containers. HSA is well-suited for testing the CCI of drug substances or products stored in glass and polymer vials at various storage conditions, especially containers stored at deep cold and cryogenic temperatures. However, several factors must be considered before embarking on designing, developing, and validating an HSA CCI method.
This webinar will begin with a brief USP <1207> overview and then discuss how a laser headspace method can be validated based on the product’s storage temperature. Finally, an overview and examples will be given on appropriately using a validated HSA CCI method to assess container shelf life, optimize and validate filling lines, and perform shipping studies.
Key Learning Objectives
- Overview of the USP <1207> chapter.
- Discuss laser-based headspace analysis and review the five container-closure formats it serves.
- Discuss how a laser-based headspace method can be validated based on storage temperature.
- Share examples of using validated CCI methods to assess shelf-life, optimize and validate filling lines, and perform shipping studies.
