The implementation of single use assemblies in manufacturing spaces has raised concerns around their proper functioning under process conditions. This is highlighted in qualification testing focusing on connections in final fill assemblies where product leaks result in high economic loss. The following case study examines the implementation of bubble emission, hydrostatic, and pressure decay tests to assess for leaks and possible egress points on final fill assemblies. These methods would be performed as part of Design Qualification (DQ) testing. DQ is performed once in the lifetime of an assembly to provide confidence that the design, included connections, tubing, fastenings, etc. will withstand process conditions. Testing in the case study was conducted on tubing engagements using model assemblies containing 89 tubing, hosebarb, and tri-clamp to tri-clamp (TC/TC) connections and fastener permutations. Execution of these tests during design qualification would provide risk mitigation to help ensure the success of single use assemblies in manufacturing.

Implementing single-use assemblies: Design qualification testing & implications

253rd National Meeting (2017)

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