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BioFlo® 320 for commercial manufacturing

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.

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    • base control station
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    N.o de catálogo M137900000

    Información del producto

    Aplicaciones

    Características

    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.

    Intelligent Sensors


    • Integrated Mettler Toledo Intelligent Sensor Management (ISM) platform
    • Universal connections for up to four analog or digital (ISM) sensors
    • pH: analog or digital (ISM)
    • DO: analog or digital (ISM)
    • Optical DO: digital (ISM)
    • Redox: analog or digital (ISM)
    • CO2: digital (ISM)
    • Real-time sensor diagnostics anticipate sensor failure

    Connectivity to DASware control plus


    To be used in clinical and commercial manufacturing, the BioFlo 320 can be connected to the powerful DASware control plus SCADA software.
    • Compatible to 21 CFR Part 11 and EudraLex Volume 4 Annex 11
    • User authentication and access control
    • Electronic records and signatures

    Use of the DASware software suite offers advanced features for process control, such as the integration of external sensors and scripting of feedback loops.

    Advanced Software Solutions to save time and mitigate risks
    • Control up to eight units from a single user interface.
    • Automatic gas mixing algorithms for simplified control (4-gas, 3-gas); O2 enrichment, N2 enrichment
    • Ten-point cascade feature for sophisticated control strategies
    • Alarm functions automatically inform about the status of the process through alarm history overview on the controller and the option to send emails when an alarm occurs.
    • The diagnostic screen provides information on the hardware status and upcoming maintenance.
    • Auto Calibrate – automatic calibration of all connected DO sensors at once significantly reduces preparation time and ensures consistency.

    Getting Insights Seamlessly and Foster Collaboration


    All data collected by DASware control can be visualized seamlessly in BioNsight cloud software.
    Enabling the user to track and monitor running processes in real-time and to analyze processes remotely.
    • Monitor all running processes in real-time.
    • Compare against the golden-batch run.
    • Share data across laboratories, sites, or even collaboration partners.
    • Leverage hybrid-modelling technology to predict critical quality attributes faster and reduce the number of experiments significantly.

    Small footprint


    From R&D laboratories to pilot-scale production facilities, space is an important factor when selecting the right equipment. The BioFlo 320 offers flexibility, better control, and maximum functionality while occupying a fraction of the valuable lab space of similar systems. This means greater efficiency and productivity at a lower operating cost for your lab.

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