The science of container closure: Headspace gas ingress methods as the golden tool
Available On-Demand:
July 11, 2024
11:00 AM ET / 10:00 AM CT / 8:00 AM PT / 3:00 PM GMT
Duration: 1 hour
Summary
It has become generally accepted that headspace gas ingress methods represent the most robust and flexible approaches for performing container closure integrity (CCI) testing throughout the product life
cycle. As one of the deterministic techniques in the USP <1207> chapter on package integrity testing, headspace methods are based on non-destructive 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 methods are the only ones to have been validated to detect gross leaks, sub-micron defects down to helium leak sensitivity, and leaks that are temporary. Methods that are developed for lab-based CCI testing can be scaled for automated in-line testing in the manufacturing environment.
Headspace methods are now regularly being implemented as the ‘golden tool’ for container closure integrity testing of all types of sterile pharmaceutical product (see references [1-4]). The use of headspace methods for recent mRNA therapies as part of a holistic science-based approach to container closure integrity assurance [5] has further demonstrated headspace as the most flexible and reliable deterministic method for CCIT.
This webinar will cover how headspace methods are developed and validated for a variety of product-container configurations including pre-filled syringes. Case studies will be presented that demonstrate
the utility of headspace methods for meeting recent specific EU GMP Annex 1 requirements such as transport validation for products needing ultracold storage temperatures.
Speaker
Derek Duncan, PhD | Director Lighthouse Instruments | Lighthouse Instruments
Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. 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
With a degree in Chemistry from the Radboud University of Nijmegen, Josine Wilmer began her career at Lighthouse Instruments in 2014. In the position of Application Scientist, Josine gained experience in various applications of headspace analysis. Currently, as the Analytical Services Product Manager, Josine 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 Josine.
Moderator
Andrea Corona | Senior Editor | Pharma Manufacturing
