Headspace Gas Ingress Methods – The Golden Tool For CCI Testing
Understanding how to develop and validate headspace methods is increasingly critical for pharmaceutical teams working with complex product-container systems. In this webinar, Dr. Derek Duncan and MSc. Josine Wilmer explores the nuances of headspace analysis across a range of configurations, including pre-filled syringes. Through detailed case studies, they demonstrate how these methods can be applied to meet evolving regulatory expectations, particularly those outlined in EU GMP Annex 1. Special attention is given to transport validation for products requiring ultracold storage, a growing concern in biologics and advanced therapies.
Whether you're optimizing container closure integrity testing or preparing for regulatory audits, gain practical insights into aligning analytical strategies with compliance demands.
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