Integrity Testing of Flexible 2D/3D Bags and Manifolds Using Helium Integrity Testing Platform (HITtm)

摘要

Switching to single-use systems can have financial and performance benefits. However, one critical challenge for complete acceptance of single-use systems is assurance of bag integrity — and in turn, product sterility and operator safety. The main risk with single-use technology is associated with leaks that can be induced by transport and handling (1). The second greatest concern regarding the use of disposables is bag breakage and related loss of production materials (2).