Final sterilizing filtration is the last operation in downstream processing to assure sterility of medicinal products for human use. There is extensive regulatory guidance for final filtration encompassing both expectations for microbial retention, as well as approaches for confirming filter integrity. As single-use systems are increasingly being adopted in final filtration, there is a focus on implementing a more holistic approach to assuring sterility of the system that encompasses both filters and components. This poster will highlight new developments in filter technology that reduce the risk of introducing contamination in pre-sterilized redundant filtration systems. They also offer opportunities for: 1. Simplified pre-use integrity testing of critical sterile filters 2. Maximized product recovery of formulated product 3. Streamlined single-use assembly design with fewer connections These developments in assembly design reduce risk, improve operation and increase robustness of this critical filtration step. In an industry focused on driving efficiency, they offer an important advancement in process risk mitigation and yield improvements.

Optimization of final filtration operations using single-use systems

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.