Full Name: SciLog SciFlex Filter and Dispense System
Team: Parker domnick hunter
Status: Game ready
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.
• Fluid flow path is completely single-use and the manifolds designed to allow closed system processing
• Closed system processing protects operators from exposure to the active biopharmaceutical compounds while minimizing the risk of contamination
• Up to 250L of bulk purified biopharmaceutical can be filtered and filled into either bioprocess containers or bottles with volumes which can be between 125 mL and 2 L
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.