Thermo Scientific HyPerforma Glass Bioreactor System
| Brand | Thermo Scientific |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Import Status | Imported |
| Model | HyPerforma Glass |
| Price Range | USD 135,000 – 405,000 |
Overview
The Thermo Scientific HyPerforma Glass Bioreactor System is a precision-engineered, benchtop-scale stirred-tank bioreactor platform designed for process development, cell culture optimization, and microbial fermentation studies in academic, biopharmaceutical, and contract development and manufacturing organization (CDMO) laboratories. Built on proven glass vessel architecture, the system operates on fundamental principles of aerobic bioprocessing—including controlled dissolved oxygen (DO) transfer, pH regulation, temperature management, and sterile agitation—enabling reproducible cultivation of sensitive mammalian cell lines (e.g., CHO, HEK293) as well as robust microbial strains (e.g., E. coli, Pichia pastoris). Its modular design supports both single-use and reusable configurations, with all wetted parts constructed from borosilicate glass (DIN 28721 Type I) and electropolished 316L stainless steel components to ensure chemical resistance, optical clarity for visual monitoring, and compliance with USP Class VI biocompatibility requirements.
Key Features
- Scalable vessel volumes: 1 L, 3 L, 7 L, and 15 L working capacities—each manufactured to ISO 9001-certified quality standards with surface roughness Ra ≤ 0.4 µm for enhanced cleanability and reduced protein adsorption.
- CFD-optimized impeller geometry: A dual Rushton–marine hybrid impeller design delivers uniform radial and axial flow patterns, minimizing hydrodynamic shear stress while maximizing volumetric mass transfer coefficient (kLa), typically achieving kLa values >100 h⁻¹ at 150 rpm in standard media.
- Integrated thermal management: Replaces traditional finger condensers with a full-circumferential cooling jacket and thermally coupled condensation loop, increasing effective heat exchange area by 2.3× and enabling cooling rates up to 2.0°C/min under controlled load conditions—validated per ASTM E2917-21 calibration protocols.
- Dual-mode operation capability: Programmable bidirectional motor control allows seamless transition between low-shear mammalian suspension culture (0–200 rpm) and high-torque microbial fermentation (0–600 rpm), eliminating the need for separate reactor systems.
- Ergonomic top-plate architecture: Features alignment windows, vertical orientation markers, and quick-release bayonet fittings to reduce assembly time by ≥40% versus conventional flanged lids; validated for ≤15-minute reconfiguration between fed-batch, perfusion, and batch modes.
- Safety-integrated heating system: Encapsulated electric heating mantle with embedded bimetallic thermal cutoff (rated at 120°C ± 3°C) and independent overtemperature alarm circuitry—compliant with IEC 61000-6-4 electromagnetic compatibility and UL 61010-1 safety standards.
Sample Compatibility & Compliance
The HyPerforma Glass Bioreactor supports a broad range of biological systems, including adherent and suspension mammalian cells, insect cells (Sf9, Sf21), yeast, bacteria, and algae. All contact surfaces meet FDA-recommended extractables and leachables (E&L) testing criteria per USP and . The system is compatible with standard sterilization methods—including autoclaving (121°C, 20 min, saturated steam), gamma irradiation (25 kGy), and vaporized hydrogen peroxide (VHP) decontamination—and maintains integrity across ≥100 sterilization cycles. Documentation packages include IQ/OQ/PQ protocols aligned with GMP Annex 1, EU GMP Part IV, and FDA 21 CFR Part 11 requirements for electronic records and signatures.
Software & Data Management
Control is managed via the optional BioCommand™ software suite (v5.2+), which provides real-time PID-controlled regulation of temperature, pH, DO, agitation speed, and gas blending (air/O₂/N₂/CO₂). The software supports audit-trail-enabled data logging (≥10 Hz sampling rate), configurable alarm thresholds with email/SMS notification, and export to CSV, PDF, or ASAM-ODS v2.1 compliant formats. Raw sensor data is timestamped with NIST-traceable UTC synchronization and stored in encrypted SQLite databases meeting HIPAA and GDPR retention policies. Optional integration with DeltaV™ DCS or Siemens Desigo CC is available through OPC UA 1.04 interface.
Applications
- Monoclonal antibody (mAb) and recombinant protein expression process development
- Cell line selection and clone screening under controlled microenvironmental parameters
- Media optimization and feed strategy evaluation using Design of Experiments (DoE)
- Bioprocess scale-down modeling for tech transfer to pilot- and production-scale stainless-steel reactors
- Regulatory filing support—including comparability studies for IND/IMPD submissions per ICH Q5A(R2) and Q5D guidelines
- Academic research in synthetic biology, metabolic engineering, and biomanufacturing education
FAQ
Is the HyPerforma Glass Bioreactor suitable for cGMP manufacturing?
No—it is intended for non-GMP process development and preclinical research. However, its design basis and documentation align with cGMP readiness principles for subsequent scale-up validation.
Can the system be integrated with existing laboratory information management systems (LIMS)?
Yes, via RESTful API endpoints and configurable middleware adapters supporting HL7, ASTM E1384, and ANSI/X12 standards.
What calibration certificates are provided with the system?
NIST-traceable calibration reports for temperature (±0.1°C), pH (±0.02 pH), DO (±0.1 % air saturation), and torque (±0.5 % FS) sensors are included with each shipment.
Are spare parts and service contracts available globally?
Yes—Thermo Fisher Scientific maintains authorized service centers in North America, EMEA, and APAC regions, with 48-hour critical-part dispatch and remote diagnostic support via TeamViewer QS.
