The superior strength and flexibility of Flexsafe® bags make them safe for critical liquid shipping applications. The robustness of Flexsafe® bags is proven by applying extensive qualification regimes that combine the most stringent standard ASTM D4169 testing and real shipping conditions. Standard shipping test data can be leveraged by end-users to support their own qualification for liquid handling & shipping in single-use systems.
A 100 % bag chamber leak test is then performed in-process before line assembly for all Flexsafe® 2D bags. In addition, we are currently developing a Supplier Integrity Test (SIT) for the complete bag and line assemblies used in critical drug substance and drug product process steps.
For those critical process steps, a 100 % point-of-use leak test avoids the risk of losing high value product and enhances patient and operator safety by ensuring that no damage occurred during shipping, storage and handling of single-use single-use 2D and 3D bags at the user site.