Thermo Scientific HyPerforma G3Lab Intelligent Bioreactor Control System

Overview

The Thermo Scientific HyPerforma G3Lab Intelligent Bioreactor Control System is a purpose-engineered, cGMP-aligned distributed control system (DCS) designed for precise, scalable, and auditable operation of upstream bioprocessing equipment. Operating on the proven Emerson DeltaV™ automation platform, the G3Lab implements deterministic real-time control logic—based on IEC 61131-3 programming standards—to regulate critical bioreactor parameters including temperature, pH, dissolved oxygen (DO), agitation speed, gas flow rates (air, O₂, N₂, CO₂), antifoam addition, and liquid feed delivery. Its architecture supports both batch and fed-batch modes across stirred-tank reactors (STRs) and orbital shaker systems up to 250 L working volume, accommodating both single-use bioreactors (SUBs) and stainless-steel vessels with steam-in-place (SIP) capability. Unlike proprietary controllers, the G3Lab delivers vendor-agnostic interoperability without compromising control fidelity or audit readiness.

Key Features

• Open-system architecture enabling seamless integration with third-party bioreactors from Sartorius, Eppendorf, Merck Millipore, and Applikon—without custom firmware or protocol translation layers
• DeltaV™-based TruBio software environment providing consistent HMI navigation, alarm management (ISA-18.2 compliant), and electronic batch record (EBR) generation across development, pilot, and manufacturing scales
• Modular hardware chassis housing certified Class I, Division 2–rated I/O modules, redundant power supplies, calibrated analog/digital input channels, and integrated peristaltic pump drivers with pulse-width modulation (PWM) control
• Pre-validated cGMP DCS framework, including built-in calibration traceability (NIST-traceable reference points), electronic signature support, and full 21 CFR Part 11 compliance—including audit trail logging, role-based access control, and data integrity safeguards
• Configurable redundancy options for critical control loops (e.g., pH/DO cascades), supporting fault-tolerant operation in GMP environments where process continuity is essential
• Unified lifecycle platform: identical control logic, configuration tools, and validation documentation apply from lab-scale (2 L) through clinical manufacturing (200–250 L), eliminating requalification effort during tech transfer

Sample Compatibility & Compliance

The G3Lab controller interfaces with a broad range of bioreactor configurations—regardless of vessel material (polymeric SUBs or 316L stainless steel), sterilization method (gamma irradiation, ethylene oxide, or SIP), or agitation mechanism (mechanical stirring, magnetic coupling, or orbital oscillation). It supports industry-standard sensor protocols including 4–20 mA, RS-485 Modbus RTU, and Foundation Fieldbus HART, ensuring compatibility with pH, DO, conductivity, level, and pressure transmitters from major OEMs. All system components meet UL 61010-1, IEC 61326-1 (EMC), and IEC 62443-3-3 cybersecurity requirements. The system is pre-qualified against ISO 13485:2016, ASTM E2500-13 (user requirement specification guidance), and USP Analytical Instrument Qualification frameworks.

Software & Data Management

TruBio software provides an intuitive, context-sensitive interface for configuring control strategies, defining setpoint profiles, and executing multi-step feeding algorithms—including exponential, linear, and state-dependent feed schedules triggered by online biomass estimates (e.g., capacitance), metabolite concentrations (e.g., glucose via inline NIR), or process deviations. All control actions are timestamped, digitally signed, and stored in a relational SQL Server database with immutable audit trails. Data export complies with ASAM ATX and ISA-95 standards, facilitating direct ingestion into MES (Manufacturing Execution Systems) and LIMS platforms. Optional DeltaV DCS historian enables long-term trending, SPC charting, and multivariate analysis (MVA) integration for process understanding and continuous improvement initiatives.

Applications

The G3Lab serves as the central control node in cell culture (CHO, HEK293, CAP-T), microbial fermentation (E. coli, P. pastoris), and viral vector production workflows. It is routinely deployed in process development labs for DoE studies, in pilot plants for scale-up verification, and in commercial GMP suites for clinical and commercial manufacturing. Typical use cases include optimization of glycosylation profiles via pH/temperature modulation, control of lactate accumulation through adaptive glucose feeding, and maintenance of viable cell density (VCD) setpoints using real-time capacitance feedback. Its modularity also supports hybrid applications such as perfusion culture with alternating tangential flow (ATF) integration and dual-vessel seed train expansion.

FAQ

Does the G3Lab support integration with existing DeltaV DCS infrastructure?
Yes—the G3Lab is natively built on the DeltaV platform and shares identical engineering tools, controller firmware, and security policies, enabling plug-and-play integration into enterprise-wide automation networks.
Can TruBio software be used for remote monitoring and intervention?
Yes—via DeltaV’s secure web-based client (DeltaV InTouch) or OPC UA-enabled third-party dashboards, with configurable access levels and session timeouts aligned with 21 CFR Part 11 Annex 11 requirements.
Is validation documentation provided with the system?
Yes—Thermo Scientific supplies a complete validation package including URS, FRS, IQ/OQ protocols and reports, risk assessments (FMEA), and traceability matrices compliant with EU Annex 15 and FDA guidance on computerized systems.
What level of technical support is available post-installation?
Thermo Fisher offers global 24/7 support through certified DeltaV engineers, including remote diagnostics, periodic health checks, and annual revalidation assistance under service-level agreements (SLAs).