(593b) Practical Implementation of Single Use Filtration Assemblies in the Final Filling Operation

Single use assemblies have gained broader acceptance over the past decade with more recent focus further downstream in the formulation and filling area.  However, installing single use filling lines can also prove challenging for operators who are more familiar with stainless steel systems.  The handling and the operation of a single use assembly is different compared to a stainless steel filtration train.  This paper will describe the practical experiences of implementing a single use final filtration assembly from the design stage through to the day to day operation.  It will cover such topics as process design considerations, unforeseen problems with the implementation of the assembly, and the operational steps involved to conduct a pre-use, post-sterilization integrity test.