What Do You Need To Qualify A Single-Use Assembly?
Single-use technology (SUT) has become a cornerstone across all phases of bioprocess manufacturing, from upstream to downstream processes, as well as in fill/finish operations. The integration of SUT typically begins with the creation of a user requirement specification (URS), where biopharmaceutical companies collaborate closely with suppliers to choose the appropriate components and assemblies to meet specific application needs. Key considerations for qualifying single-use systems often include physical, functional, biological, chemical, and sterilization properties. This webinar covers best practices for qualifying single-use systems, focusing on quality and regulatory documentation.
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