Workshop | Container Closure Integrity - Copenhagen, Denmark

The newly updated EU GMP Annex 1 regulations now require that sterile pharmaceutical products comply with stricter container closure integrity (CCI) standards. This change has led to the development of new best practices for container closure integrity testing of sterile pharmaceutical containers.

To help you navigate these changes, Lighthouse - with decades of experience in laser-based headspace analysis and CCI testing is offering a unique workshop.

This workshop is designed to provide delegates with the knowledge and tools required to develop a customized CCIT strategy and roadmap that covers the entire product life cycle, from primary package component selection to final product testing.

In addition to technical presentations from CCI Application Experts, the workshop will feature industry case studies and in-depth laboratory demonstrations that will give delegates practical insights and hands-on experience.

• Understanding the new EU GMP Annex 1 regulations and requirements for CCI testing

• Learning from industry case studies and practical examples that cover a range of container configurations, including vials, syringes, cartridges, bottles, and cryo tubes

• Developing a science-based and holistic approach to CCI testing throughout the product life cycle, from primary package component selection to final product testing

• Recognizing the importance of detecting temporary leaks for freeze-dried products and products that require cold storage

• Identifying when and how to apply laser-based headspace analysis as a CCI testing solution

• Gaining hands-on experience with CCI test methods for different product types and packages

Host or Publisher LIGHTHOUSE Instruments