Supplier Integrity Testing (SIT) for Celsius^®️ Bag Assemblies

Single-use frozen storage and shipping solutions are increasingly employed in bioprocesses owing to their robustness, flexibility, and ease of use. As they are in direct contact with drug substance | drug product, the integrity of these containers is crucial for drug quality and operator exposure. 

This application note summarizes the validation of our integrity testing method (which uses a helium tracer gas test) employed during the production of our Celsius^®️ FFT single-use assemblies. With its 2 µm detection limit, the test provides integrity assurance correlated to microbial ingress and liquid leaks under the most severe use-case conditions of these single-use assemblies.