What Do You Need To Do To Qualify A Single-Use Assembly?

Single-use technology (SUT) is now well-established across all stages of bioprocess manufacturing, encompassing upstream, downstream, and fill/finish operations. The adoption of SUT typically begins with the creation of a user requirement specification (URS). Biopharmaceutical company end users collaborate closely with suppliers to choose components and assemblies that align with the requirements of their application. The qualification of single-use systems and related regulatory considerations often involve evaluating physical, functional, biological, chemical, and sterilization properties. In this webinar, you will learn about best practices for single-use qualification, including the necessary quality and regulatory documentation.