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BioFlo® 320 for commercial manufacturing

产品信息

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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    • 用于 BioFlo® 320
    • 控制台
    更多产品详情...
    目录编号 M1379-0102

      • 基础控制台
      • 包含确认文件
      更多产品详情...
      目录编号 M137900000

      产品信息

      用途

      特征

      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.


      Eppendorf Bioprocess Products – application in GMP regulated environment
      Download document to find out which features you can expect at minimum from Eppendorf products that are deemed suitable or compatible for GMP.

      集成 智能传感器


      • Mettler Toledo智能传感器管理(ISM)平台
      • 配备通用接口,可以同时连接四个模拟或数字传感器
      • pH:模拟或数字(ISM)
      •  DO:模拟或数字(ISM)
      • 光学DO:数字(ISM)
      • 氧化还原:模拟或数字(ISM)
      •  CO 2: 数字(ISM)
      • 实时传感器诊断可预测传感器故障

      连接DASware control plus控制软件


      为应用于临床和商业生产, BioFlo 320可以连接功能强大的DASware control plusSCADA软件。
      • 符合21 CFR Part 11与EudraLex第4卷附录11相关规定
      • 用户身份验证与访问控制
      • 电子记录与签名

      使用DASware软件套件可为过程控制带来更多先进功能,如集成外部传感器、反馈回路脚本撰写。

      先进软件解决方案有助节省时间并降低风险
      • 通过单一用户界面同时控制最多八台设备
      • 自动气体混合算法,简化气体控制(4-gas,3-gas)、增O2、增N2流程
      • 十点级联,能够实施复杂的控制策略
      • 警报功能,可通过控制器上的警报历史概览自动通报工艺状态,也可在警报发生时向用户发送电子邮件。
      • 诊断屏幕显示硬件状态信息和下次维护信息。
      • 自动校准——一次性自动校准所有连接的溶氧传感器,能够显著缩短准备时间、确保一致性。

      无缝数据获取,增进协作


      由DASware control 采集的所有数据均可通过BioNsight cloud软件实现无缝可视化。
      便于用户实时跟踪和监测运行过程,并对运行过程进行远程分析。
      • 实时监测所有运行过程。
      • 与黄金批次运行进行对比。
      • 跨实验室、站点甚至合作伙伴共享数据。
      • 利用混合建模技术加快关键质量属性预测速度、大幅减少实验次数。

      占地面积小


      从研发实验室到中试生产工厂,所占空间大小是挑选合适设备时的一项重要考量因素。BioFlo 320应用灵活、控制出色、功能完善,但其占地面积较同类产品大幅减少,有助节省实验室宝贵空间。从而让您的实验室运行成本更低、效率和生产力更高。