News And Announcements

Helium mass spectrometry has a long history of implementation for high-sensitivity leak detection in a range of industries. Intended for individuals of all CCI experience levels, this first of two helium-related webinars provides participants with historical context on the use of helium leak detection, an understanding of its key operating principles, and how the technology is most commonly applied to assess pharmaceutical packaging.

As with all CCI methods, helium leak detection has advantages and disadvantages that largely dictate the applicability of the technology in a specific use-case. Key considerations for applications of helium shall be discussed, including a brief comparison to other deterministic CCIT methodologies listed in USP <1207>.

Comprehensive CCI strategies reflecting best practices often implement various methods at different lifecycle stages. The toolbox approach is a way of conceptualizing this process. Each CCI technology has appropriate applications, as would each tool in a toolbox. However, even for a given tool, there may be multiple applications: a hammer is just as suitable for removing a popped nail as pushing one in. The same can be said for a given CCI technology, such as helium leak detection.

Building off of the basic operating principles and test techniques employed for pharmaceutical packaging discussed in Webinar 1, this second webinar seeks to discuss helium leak detection in the context of USP <1207> Lifecycle approach to CCI and its applicability in package development and validation, including assessment to the MALL. Participants shall gain insight into real-world applications through review of use-cases such as vial capping optimization, plunger movement studies, and cold-storage assessments.

CS Analytical