Headspace Gas Ingress Methods: The Golden Tool for Container Closure Integrity Testing

This webinar will cover how headspace testing methods are developed and validated for a variety of product-container configurations, including assembled autoinjectors.

Register Free: https://www.pharmtech.com/pt_w/golden-tool

Event Overview:

It has become generally accepted that headspace gas ingress testing methods represent the most robust and flexible approaches for performing container closure integrity testing (CCIT) throughout the product life cycle. As one of the deterministic techniques in the USP <1207> chapter on package integrity testing, headspace testing methods are based on nondestructive analytical measurements and are recommended for use in container closure integrity testing throughout the product life cycle to generate science-based CCI data that, coupled with a risk-based approach, enables informed decisions about a CCIT strategy in commercial manufacturing. Headspace testing methods are the only ones to have been validated to detect gross leaks, submicron defects down to helium leak sensitivity, and leaks that are temporary.

Methods that are developed for lab-based CCIT can be scaled for automated in-line testing in the manufacturing environment. Headspace testing methods are now regularly being implemented as the “golden tool” for container closure integrity testing of all types of sterile pharmaceutical products. The use of headspace testing methods for recent mRNA therapies as part of a holistic science-based approach to container closure integrity assurance has further demonstrated headspace testing methods as the most flexible and reliable deterministic method for CCIT.

This webinar will cover how headspace testing methods are developed and validated for a variety of product-container configurations, including assembled autoinjectors. Case studies will be presented that demonstrate the utility of headspace testing methods for meeting recent specific European Union good manufacturing practice Annex 1 requirements, such as transport validation and raised stopper height sensor qualification.

Key Learning Objectives:

• Learn how to apply headspace CCI testing methods for all types of sterile pharmaceutical products.
• Learn how to design packaging development studies that enable CCI assurance.
• Learn how to design production line CCI qualification studies in a holistic science-based approach.

Who Should Attend:

• Personnel in packaging development, quality control, and manufacturing inspection
• Personnel in quality assurance and manufacturing science and technology

Speakers

Derek Duncan, PhD
Director
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, MSc
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.

Register Free: https://www.pharmtech.com/pt_w/golden-tool