Currently, there are no industry standards for how engagement qualifications should be performed when verifying that all components of a single-use assembly are securely connected. This leaves room for individual organizations to interpret on what factors to consider in testing. In lieu of formal industry guidance, it’s important to review the factors related to the selection of retention device and assembly, along with the variables to be considered in selecting a testing approach.
The BPE is currently developing an information-sharing questionnaire around single-use mechanical hose barb connections, which will allow end users to ask the right questions to single-use integrators to help them assess the robustness of any performed engagement qualification testing on the supplier side. Review important information on engagement factors, engagement testing considerations, and single-use integrator considerations.