WEBINAR

Testing and Control Strategies for Container Closure Integrity

Discover how evolving regulations, novel therapies, and advanced delivery systems are driving innovative strategies in container closure integrity testing, illustrated through real-world pharmaceutical case studies.

June 25, 2025

2:00 PM UTC

1 hour

Sponsored by

Available on: June 25, 2025
10:00 AM ET / 9:00 AM CT / 7:00 AM PT / 2:00 PM GMT

Sponsor: Lighthouse Instruments B.V.

Summary

Best practices for assuring container closure integrity have and will continue to evolve in response to the implementation of the revised EU GMP Annex 1 and the announced revision of the USP Package Integrity Evaluation – Sterile Products chapter. In addition, the continued development of novel therapies (cell & gene therapies) as well as the increased use of complex delivery systems such as autoinjectors, have required new approaches and methods for container closure integrity (CCI) testing.

This presentation uses industry case study examples to describe how pharmaceutical facilities are defining strategies and evolving best practices to comply with new container closure requirements. The case studies illustrate various topics including the validation of container closure integrity test methods for novel therapies and containers, generating CCI data in a product life cycle approach, and the choice to perform 100% leak detection vs. sampling in commercial manufacturing.

Speakers

Derek Duncan, PhD

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Lighthouse Instruments

Derek Duncan, PhD, began his career at the Dutch Institute for Atomic and Molecular Physics in Amsterdam. He moved into industry, holding product and application development positions. Having been at Lighthouse Instruments since 2003, Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

Josine Wilmer

Analytical Services Product Manager

Lighthouse Instruments

With a degree in chemistry from the Radboud University of Nijmegen, the Netherlands, Josine Wilmer, MSc, began her career at Lighthouse Instruments in 2014. In the position of application scientist, Wilmer gained experience in various applications of headspace analysis. Currently, as the analytical services product manager, Wilmer is globally responsible for the analytical services performed at the Lighthouse laboratories. Since container closure integrity testing is a leading application of headspace analysis, CCI has become an area of expertise for Wilmer.

Moderator: Andrea Corona

Senior Editor

Pharma Manufacturing

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