SciLog SciFlex Filter and Dispense System
Full Name: SciLog SciFlex Filter and Dispense System Debut: June, 2014 Field Position: Downstream biopharmaceutical process environments Skill Set: Automates final bulk filtration and container filling, a step previously performed in a manual fashion within a vertical laminar flow cabinet. Performance Stats: Regulatory Profile: Supports cGMP and QbD-based biopharmaceutical processing regimes Coach’s Notes: “The system can perform manual filtrations, constant pressure, constant flow rate or Parker domnick hunter’s patented R/P Stat Method, a hybrid method that maximizes filtration capacity. Following the filtration and prior to the fill into the containers an automated, in-situ filter integrity test is performed. In the event of an integrity test fail the system allows for reprocessing and a second filtration to be performed. A barcode interlocking mechanism prevents operation with incorrectly loaded manifolds. The system can be used with a Parker domnick hunter filter or any commercially available filter capsule, as part of an open architecture design. A touch-screen interface allows operators to access intuitive, easy to learn and use software." Scout’s Notes: “Fujifilm Diosynth Biotechnologies sees the installation of the SciFlex Filter and Dispense System into cGMP manufacturing as a critical success factor in achieving compliant, right the first time manufacture of biologic pharmaceuticals," says Dr. Paul Bird, Manufacturing Engineering Group Head, Fujifilm Diosynth Biotechnologies." Team Resources: Parker domnick hunter provides integrated bioprocessing solutions that speed up development times, increase efficiency and safety, and enable reproducible quality. Incorporating SciLog, we combine filtration, single-use fluid-handling systems and sensors, and automated single-use solutions.
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