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BioFlo® 320 for commercial manufacturing
BioFlo 320 with BioBLU 50c and scale

El BioFlo 320 es compatible con recipientes de un solo uso BioBLU de 250 mL - 40 L.
Información del producto
The BioFlo 320 is a universal bench-scale bioreactor system for both process development and clinical and commercial manufacturing. Powerful technology for precise process monitoring and control, a large working volume range, and software features that save time and reduce risks make it a reliable partner for developing robust processes and scaling them up from R&D to manufacturing. It is suitable for cell culture as well as fermentation application.Encontrará material adicional para descargar en laparte inferior de esta página
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Información del producto
Aplicaciones
Características
Información del producto
The BioFlo 320 seamlessly connects R&D to clinical and commercial manufacturing
The BioFlo 320 is compatible with a wide selection of bioreactors, providing working volumes from 400 mL to 40 L on a single platform. In combination with the BioFlo 720 bioreactor control system, the BioFlo platform supports one of the widest range of single-use solutions, allowing the scale-up of your process to up to 500 L.
• Validation Guide available to support controller qualification for manufacturing applications.
• In combination with BioBLU HNQ Single-Use Bioreactors, DASware control plus SCADA software, and service offerings for qualification and calibration, the BioFlo 320 provides a unified solution to support compliance with GMP requirements.
• Integrated Scale Up Assist software feature simplifies the calculation of important process parameters necessary to scale up and down.
• Emerson® DeltaV integration with the BioFlo 320 simplifies tech-transfer, scale-up, and recipe sharing.
The BioFlo 320 is highly configurable to meet your application needs
Advanced technical features make the BioFlo 320 a powerful tool for R&D as well as manufacturing. A high level of application flexibility is made possible by features like universal connections for analog and digital sensors, up to six integrated pumps, a highly configurable gas flow control, and compatibility with a wide range of glass and single-use bioreactors.
• Suitable for the cultivation of human and animal cells, including stem cells, as well as microbial fermentation.
• Supports batch, fed-batch, continuous, and perfusion mode.
• Suitable for many applications, including the production of cells, secreted proteins, viral vectors, plasmids, and small molecules.
The BioFlo 320 is compatible with a wide selection of bioreactors, providing working volumes from 400 mL to 40 L on a single platform. In combination with the BioFlo 720 bioreactor control system, the BioFlo platform supports one of the widest range of single-use solutions, allowing the scale-up of your process to up to 500 L.
• Validation Guide available to support controller qualification for manufacturing applications.
• In combination with BioBLU HNQ Single-Use Bioreactors, DASware control plus SCADA software, and service offerings for qualification and calibration, the BioFlo 320 provides a unified solution to support compliance with GMP requirements.
• Integrated Scale Up Assist software feature simplifies the calculation of important process parameters necessary to scale up and down.
• Emerson® DeltaV integration with the BioFlo 320 simplifies tech-transfer, scale-up, and recipe sharing.
The BioFlo 320 is highly configurable to meet your application needs
Advanced technical features make the BioFlo 320 a powerful tool for R&D as well as manufacturing. A high level of application flexibility is made possible by features like universal connections for analog and digital sensors, up to six integrated pumps, a highly configurable gas flow control, and compatibility with a wide range of glass and single-use bioreactors.
• Suitable for the cultivation of human and animal cells, including stem cells, as well as microbial fermentation.
• Supports batch, fed-batch, continuous, and perfusion mode.
• Suitable for many applications, including the production of cells, secreted proteins, viral vectors, plasmids, and small molecules.


Sensores inteligentes
• Plataforma integrada de gestión inteligente de sensores (ISM) de Mettler Toledo
• Conexiones universales para hasta cuatro sensores analógicos o digitales (ISM)
• pH: analógico o digital (ISM)
• OD: analógico o digital (ISM)
• OD óptico: digital (ISM)
• Redox: analógico o digital (ISM)
• CO2: digital (ISM)
• El diagnóstico de los sensores en tiempo real anticipa su fallo




Conectividad con DASware control plus
Para su uso en la fabricación clínica y comercial, el BioFlo 320 puede conectarse al potente software SCADA DASware control plus.
• Compatible con las normas 21 CFR Part 11 y EudraLex Volume 4 Annex 11
• Autenticación de usuarios y control de acceso
• Registros y firmas electrónicos
El uso del paquete de software DASware ofrece funciones avanzadas para el control de procesos, como la integración de sensores externos y la programación de bucles de realimentación.
Soluciones informáticas avanzadas para ahorrar tiempo y mitigar riesgos
• Controle hasta ocho unidades desde una única interfaz de usuario.
• Algoritmos automáticos de mezcla de gases para un control simplificado (4 gases, 3 gases); enriquecimiento de O2, enriquecimiento de N2
• Función de cascada de diez puntos para estrategias de control sofisticadas
• Las funciones de alarma informan automáticamente sobre el estado del proceso mediante un resumen del historial de alarmas en el controlador y la opción de enviar correos electrónicos cuando se produce una alarma.
• La pantalla de diagnóstico proporciona información sobre el estado del hardware y el próximo mantenimiento.
• Auto Calibrate: la calibración automática de todos los sensores de OD conectados a la vez reduce significativamente el tiempo de preparación y garantiza la coherencia.




Obtenga información sin dificultades y fomente la colaboración
Todos los datos recogidos por DASware control pueden visualizarse perfectamente en el software BioNsight cloud.
Esto permite al usuario rastrear y supervisar los procesos en ejecución en tiempo real y analizar los procesos de forma remota.
• Supervise todos los procesos en ejecución en tiempo real.
• Compare con la ejecución del lote de oro (golden batch).
• Comparta datos entre laboratorios, centros o incluso socios colaboradores.
• Aproveche la tecnología de modelización híbrida para predecir atributos de calidad críticos con mayor rapidez y reducir significativamente el número de experimentos.




Diseño compacto
Desde los laboratorios de I+D hasta las instalaciones de producción a escala piloto, el espacio es un factor importante a la hora de seleccionar el equipo adecuado. El BioFlo 320 ofrece flexibilidad, mejor control y máxima funcionalidad, al tiempo que sólo ocupa una fracción del valioso espacio de laboratorio de sistemas similares. Esto se traduce en una mayor eficiencia y productividad con un coste de funcionamiento inferior para su laboratorio.


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Aplicaciones
- Universal bench-scale controller for cell culture and fermentation applications in R&D and clinical and commercial manufacturing
- Fermentation of aerobic and anaerobic bacteria, yeasts, and fungi
- Cultivation of mammalian, insect, and human cell lines
- Cultivation of stem cells
- Specialized packed-bed impeller for the cultivation of anchorage and non-anchorage dependent cells, for example for vaccine process development
- Cell culture on microcarriers using specialized cell-lift impeller
- Suitable for batch, fed-batch, and continuous/perfusion processes
- Validation Guide available to support controller qualification for manufacturing applications1)
Características
- Universal control for both microbial and cell culture applications
- Controls up to eight systems from a single user interface
- Compatible with BioBLU HNQ Single-Use Bioreactors
- Up to six integrated pumps capable of operating in variable-speed mode
- Integrated Mettler Toledo® ISM® platform
- Built-in optical pH sensing technology for use with the BioBLU HNQ Single-Use Bioreactors
- Field-upgradable TMFC drawers for sparge and overlay gas
- Eight independently controlled process gas supplies
- Enhanced software package with new cascade and time profile features
- DeltaV compatibility available through DeltaV Discovery and DeltaV ProPlus PAS
- Validation Guide available to support controller qualification for manufacturing applications.
- Compatible with 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compatible DASware control plus SCADA software
Descargas: BioFlo® 320 for commercial manufacturing
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