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Materials Science and Engineering
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
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Risk Reduction In Single-Use Assemblies By Implementing Helium Integrity Test And A New Point-Of-Use Leak Test Using Palltronic® Flowstar Lgr Instrument For Critical Formulation And Filling Applications, Anil Kumar, Vishwas Pethe, Ralf Kuriyel, Helene Pora
Risk Reduction In Single-Use Assemblies By Implementing Helium Integrity Test And A New Point-Of-Use Leak Test Using Palltronic® Flowstar Lgr Instrument For Critical Formulation And Filling Applications, Anil Kumar, Vishwas Pethe, Ralf Kuriyel, Helene Pora
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
This presentation will focus on challenges with implementation of single use, including robustness concerns, ensuring closures, integrity of multi-polymer systems both during manufacturing as well as at point of use. Despite numerous challenges, rapid adoption of single-use technologies still continues due its application in both more critical applications and expansion to commercial scale. More particularly, single use bioprocessing assemblies (Biocontainers and multi component single use systems) are being utilized in increasingly critical and demanding applications such as for holding and transporting sterile bulk drug substance and formulation and final filling. Therefore, potential of product loss and operator safety risk, have …
Container Closure Integrity (Cci) For Single-Use Systems (Sus): Regulatory Trends, Challenges And Technology Transfer Of Test Methods, Carole Langlois, Marc Horeve
Container Closure Integrity (Cci) For Single-Use Systems (Sus): Regulatory Trends, Challenges And Technology Transfer Of Test Methods, Carole Langlois, Marc Horeve
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
Single-use fluid management solutions are being applied in critical downstream and final filling applications including applications requiring container closure integrity testing. Single-use bags are increasingly used for the storage, mixing, shipping, freezing of drug substances and drug products. Since single use bags are migrating towards more critical process steps and applications, there is a growing regulatory scrutiny and industry requirement for testing the containers in order to guarantee their integrity and their sterility before their use in commercial production processes.
This presentation will consider the regulatory trends for Container Closure Integrity of single-use systems with a focus on the proposed …