Headspace Gas Ingress As A Replacement Of Dye Ingress For Container Closure Integrity Testing

By Derek Duncan

Container closure integrity (CCI) is fundamental for maintaining the sterility and stability of sterile injectable products. Regulators are requiring the execution of robust CCI studies that generate data throughout the product life cycle using analytical test methods when possible. This shift in industry best practices acknowledges the importance of quantitative method validation demonstrating the detection of critical leaks. Recently, a headspace gas ingress method has been developed that both resembles and improves upon the traditional blue dye ingress test. This eBook includes:

• An Introduction to Headspace Gas Ingress as a replacement for Blue Dye
• Method Development for a CCI Test using Headspace Gas Ingress
• Case study examples, including CCI Test Method Validation for Pre-filled Syringes
• Key features and system specifications of the Headspace Analyzer