Lukas Engel
Leak Testing Expert Pharma CCIT
The Integrity Dilemma: Open Precision or Closed Reality?
Open vs. closed container CCIT: understand helium testing limits and explore OES as a reliable alternative for production environments.
What is the webinar about?
Helium leak detection provides highly sensitive and quantitative results, but its application varies depending on the objective of the test – from packaging validation in R&D to process qualification and, in some cases, testing of closed containers in production.
While precise tracer gas concentration can be ensured when testing open containers, closed containers introduce a key challenge: the helium concentration inside the container may change over time, directly impacting the reliability of the measurement.
This webinar compares open and closed container testing approaches and highlights the implications for tracer gas management and result interpretation. It also addresses how these differences influence testing strategies across development and production environments.
In addition, Optical Emission Spectroscopy (OES) is introduced as a non-destructive alternative for closed-container testing. By eliminating tracer gas handling, it avoids risks related to permeation or contamination while still achieving sensitivity close to the Maximum Allowable Leakage Limit (MALL).
Finally, we discuss when helium testing reaches practical limits and how to select the most appropriate CCIT strategy depending on the application.
Who should attend?
This webinar is intended for professionals involved in pharmaceutical packaging, quality assurance, validation, and process development who want to understand the differences between open and closed container testing and select the right CCIT strategy.
