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.