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Smart-BioFlex™ Software Suite

Advanced SCADA & Automation for Bioreactors, Utilities, and GMP Bioprocessing

Smart-BioFlex™ is KBiotech’s powerful SCADA + HMI automation platform—designed to control, monitor, and scale bioprocesses from R&D labs to 50,000 L GMP production systems.

Built on robust PLC/DCS architecture, Smart-BioFlex™ seamlessly integrates with bioreactors, CIP/SIP units, filtration modules, and media prep tanks. It provides real-time control, adaptive automation, and full 21 CFR Part 11 compliance—ensuring both operational agility and regulatory traceability.

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Why Choose Smart-BioFlex™?

Smart-BioFlex™ offers a compelling set of advantages that make it suitable for both small-scale and large-scale bioprocessing. Its scalable architecture allows the same platform to be used seamlessly from benchtop reactors all the way to 50,000 L industrial fermenters.

Thanks to modular device drivers, new instruments can be added without any recoding or system restarts, ensuring true operational flexibility. The system’s adaptive automation supports cascade control, event-based logic, and real-time tuning, while built-in analytics provide DOE tools, batch comparison capabilities, and advanced process-optimization features. 

Smart-BioFlex™ is also 21 CFR Part 11 ready, offering full audit trails, secure user authentication, and electronic signatures. Designed with reliability in mind, it includes built-in redundancy so that SCADA automatically takes over control if a PLC fails. Finally, its plug-and-play connectivity ensures smooth integration with MES, LIMS, ERP, OPC-UA, and SmartFlex™ ecosystems.

Core Automation Capabilities

Multi-Unit Control

Manage up to 12 systems simultaneously (bioreactors, SIP, media prep)

Recipe Management

Build, execute, and reuse validated process workflows

Cascade Logic

Fine-tune pH, DO, agitation, gas flow, and biomass using multi-tiered logic

Event-Based Automation

Trigger steps via time, sensor feedback, or system events

Automated CIP/SIP

Fully validated sterilization and cleaning cycles

Data Logging & Filtering

SQL storage, offline recovery, statistical trend smoothing

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User Interface & Visualization Tools

  • Interactive Synoptic Views: Live, clickable P&IDs of full systems
  • Overlay Charting: Compare real-time performance to golden batches
  • Trend, Scatter, Bar Graphs: Visualize dynamic process relationships
  • Custom Dashboards: Role-based displays for QA, operators, and engineers

System Architecture

Local PLC Layer

  • Direct equipment control
  • Safety interlocks and
    redundancy
  • Operates independently from SCADA layer

SCADA Server Layer

  • Centralized logic and database
  • Alarm handling, recipe scheduling
  • 21 CFR Part 11 compliance and user management

Client & Enterprise Layer

  • Multi-user access with secure roles
  • OPC-UA, COM, and API integration to MES/LIMS/ERP
  • Cloud-ready and remote monitoring enabled

GMP Compliance & Validation

  • 21 CFR Part 11 – Audit trails, secure login, e-signature, time-stamped records
  • GAMP 5 Support – Validation packages: URS, FDS, DQ, IQ, OQ, PQ
  • Data Integrity – Encrypted SQL database with automatic redundancy
  • Audit-Ready Reporting – Built-in reporting engine with exportable logs

Compatible Hardware & Integration

Smart-BioFlex™ is designed for seamless integration with the full range of KBiotech equipment. It works natively with bioreactors of all scales—lab, pilot, and industrial—as well as with CIP/SIP skids and buffer or media preparation tanks. The platform also supports single-use systems and SmartFlex™ utility modules, while maintaining full compatibility with third-party sensors, mass-flow controllers, and analytical devices.

What Makes Smart-BioFlex™ Different?

Smart-BioFlex™ stands apart thanks to its advanced integrated capabilities. It includes built-in analytics that support DOE modeling, control tuning, and golden-batch comparisons, giving operators deeper insight and faster optimization. The platform is fully device-independent, working seamlessly with systems like Siemens, Rockwell, DeltaV, and many others. Its no-code architecture allows users to add pumps, sensors, and analyzers in just seconds, while the UX-driven interface is designed to be operator-friendly, multilingual, and responsive across devices.

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Call us or request a back call to contact our specialists

+41 916 300 115

For presales questions and your order status email us at

sales@kbiotech.ch
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Application Type
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Working Volume Range
Volumes range: 500L - 50.000L
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Sterilization in Place (SIP)
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Cleaning in Place (CIP)
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Automation Level
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Steam Generator Required
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Technical Specifications
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