Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products for human use. As single-use systems are increasingly being adopted in all areas of bioprocessing, there is a focus on implementing a more holistic approach to assuring the sterility of the system that encompasses the filters and components.
We will focus on aspects of new product and system design that help customers meet regulatory expectations and reduce contamination risk while maximizing product recovery. These changes offer an important opportunity for process risk mitigation and product yield improvements.
In this webinar, you will learn:
- How filter design can reduce the risk of contaminating the aseptic flow path
- How SURF assemblies can be optimized for PUPSIT and to maximize product recovery
- How SU needle packaging can reduce the risk of contamination during assembly handling and installation
Speaker
Chuck Raye
Merck
Senior Strategic Product Manager, Single-use Fill Finish Products
Chuck Raye has 14 years of experience in the bioprocessing industry, designing, validating, and managing single-use (SU) components and systems. He has also supported operational teams in the manufacturing of SU systems. In his current role, he works directly with customers, R&D, and operations to develop solutions that advance SU technology in the fill finish processes of sterile filtration and filling. Chuck holds a B.S. in mechanical engineering from Syracuse University.
Pharma and biopharma manufacturing
- Final Sterile Filtration
Duration:43min
Language:English
Session 1:presented June 25, 2020
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