Thermo Scientific HyPerforma Benchtop Single-Use Bioreactor System
| Brand | Thermo Scientific |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Import Status | Imported |
| Model | Benchtop Bioreactors |
| Price Range | USD 135,000 – 405,000 |
Overview
The Thermo Scientific HyPerforma Benchtop Single-Use Bioreactor System is an engineered platform for scalable, reproducible mammalian and microbial cell culture under research, process development, and cGMP-compliant manufacturing conditions. Designed around a sterile, pre-sterilized (γ-irradiated), single-use vessel architecture, the system eliminates cleaning-in-place (CIP) and sterilization-in-place (SIP) validation burdens while maintaining strict control over critical process parameters—pH, dissolved oxygen (DO), temperature, agitation, and gas sparging. Its core measurement principle relies on optical fluorescence-based sensing (TruFluor™ technology) for non-invasive, drift-free, real-time monitoring of pH and DO, complemented by integrated temperature feedback and motor-driven impeller control. The system’s modular design supports seamless transition from lab-scale feasibility studies to clinical batch production, aligning with Quality-by-Design (QbD) frameworks and early-stage bioprocess digitalization requirements.
Key Features
- Pre-sterilized 3 L single-use vessel delivered γ-irradiated (25–40 kGy), ready for immediate aseptic connection and operation without autoclaving or validation of sterility.
- Material compliance: latex-free, phthalate-free, bisphenol-A (BPA)-free, and animal-derived component-free construction—validated per ISO 10993 (biocompatibility) and USP Class VI testing for cytotoxicity, sensitization, and systemic toxicity.
- Integrated TruFluor™ optical sensors embedded in the vessel base: simultaneous, recalibration-free measurement of pH, DO, and temperature with high signal stability across extended culture durations (>14 days).
- Modular top plate configuration supporting optional electrochemical electrodes (e.g., redox, CO₂, glucose), enabling multi-parameter monitoring within laminar flow hoods or isolators without compromising sterility.
- Optional electric heating jacket with dual-limit thermal protection: redundant bimetallic cut-off switches prevent overheating and eliminate fire risk during ambient temperature excursions or controller failure.
- Scalable hardware configuration: customizable impeller type (e.g., marine, Rushton, pitched-blade), sparger geometry (large-bubble A-type for minimum working volume ≥1.5 L), and port layout based on cell line sensitivity and mass transfer requirements.
Sample Compatibility & Compliance
The HyPerforma system accommodates suspension-adapted CHO, HEK293, CAP-T, and hybridoma cell lines, as well as select microbial strains (e.g., E. coli BL21, Pichia pastoris) under aerobic or microaerobic conditions. Vessel wetted materials—polyethylene terephthalate glycol (PETG) body, ethylene vinyl alcohol (EVOH)-coated film, and medical-grade silicone tubing—are compliant with USP , ISO 10993-5/-10/-11, and EU Regulation (EC) No 1935/2004. Process data integrity meets ALCOA+ principles; audit trails, electronic signatures, and user access controls are fully supported in TruBio software per FDA 21 CFR Part 11 and Annex 11 requirements.
Software & Data Management
TruBio software serves as the unified control and analytics interface, providing real-time PID-regulated parameter control (pH via CO₂/NaOH, DO via O₂/N₂/air blending, temperature via jacket setpoint), automated calibration logging, and configurable alarm thresholds. All sensor data—including raw fluorescence intensity, calculated pH/DO values, and actuator status—are timestamped, encrypted, and stored in a relational database compliant with ICH M7 and GAMP5 standards. Export formats include CSV, PDF batch reports, and native .trubio files for trend analysis in third-party platforms (e.g., SIMCA, MATLAB). Full version history, change logs, and 21 CFR Part 11-compliant electronic records ensure traceability through regulatory audits.
Applications
- Monoclonal antibody (mAb) and recombinant protein process development under DOE-guided experimental designs.
- Cell line selection and clone screening with parallel 3 L runs under identical environmental setpoints.
- cGMP-compliant production of Phase I/II clinical material in qualified cleanroom environments (ISO Class 5/7).
- Process characterization studies including scale-down model qualification per ICH Q5A(R2) and Q5D guidelines.
- Education and training in bioprocess engineering curricula requiring hands-on, low-risk exposure to cGMP-aligned workflows.
FAQ
Is the 3 L vessel compatible with perfusion-mode operation?
Yes—the vessel supports gravity-fed or pump-driven perfusion configurations using optional bottom-outlet manifolds and external filter housings; maximum viable cell density exceeds 20 × 10⁶ cells/mL under continuous harvest.
Can TruFluor sensors be recalibrated in situ?
No—TruFluor optical sensors are factory-calibrated and do not require field recalibration; their drift is <±0.05 pH units and <±0.2% air saturation over 14 days per ISO 13485-verified QC release testing.
What level of cybersecurity is implemented in TruBio software?
TruBio v3.2+ implements TLS 1.2 encryption for network communications, Windows Active Directory integration, role-based permissions (Admin/Operator/Viewer), and automatic log rotation with 90-day retention—fully aligned with NIST SP 800-53 Rev. 5 IA-2 and RA-5 controls.
Does the system support integration with MES or SCADA platforms?
Yes—OPC UA (v1.04) server functionality is embedded, enabling bidirectional data exchange with Siemens SIMATIC IT, Rockwell FactoryTalk, and other ISA-95 Level 2/3 systems via secure authenticated channels.
