Thermo Scientific HyPerforma SUF Single-Use Fermenter
| Brand | Thermo Scientific |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Origin Category | Imported |
| Model | HyPerforma SUF |
| Volume Options | 30 L and 300 L |
| Scale-up Ratio | 5:1 |
| Aspect Ratio (H | D): 3:1 |
| Drive Configuration | Top-mounted agitator |
| Mixing System | Patented Rushton turbine–based impeller set with integrated sparger and exhaust management |
| Jacketing | Side and bottom thermal jacket for efficient heat transfer |
| Sensor Integration | Integrated temperature, pH, DO, foam, and pressure sensors (single-use compatible) |
| Sterile Port Count | ≥8 (for aseptic filling, sampling, draining, gas inlets/outlets) |
| Foam Detection | Advanced capacitive foam sensor with real-time feedback loop |
| Cable Management | Modular, service-loop–optimized routing system |
| Tooling Support | Adjustable tool rack with ergonomic access |
| Compliance | Designed to support cGMP, FDA 21 CFR Part 11, and ISO 13485-aligned workflows |
| Software Platform | Compatible with Thermo Scientific™ BioProcess™ Control Software (BPCS) v4.0+ |
Overview
The Thermo Scientific HyPerforma SUF Single-Use Fermenter is an engineered solution for scalable, regulatory-compliant bioprocess development and manufacturing of therapeutic proteins, monoclonal antibodies, viral vectors, and other biologics. Based on the well-established stirred-tank reactor (STR) architecture, the HyPerforma SUF maintains critical hydrodynamic and mass-transfer characteristics—including a fixed 3:1 height-to-diameter ratio and top-driven agitation—ensuring consistent mixing efficiency, oxygen transfer (kLa), shear profile, and cell viability across scales. Unlike conventional stainless-steel fermenters, the SUF integrates all fluid-contact components into a pre-sterilized, gamma-irradiated single-use bag assembly (S.U.F. BPC), eliminating cleaning-in-place (CIP) and sterilization-in-place (SIP) validation burdens while reducing cross-contamination risk and turnaround time between batches. Its 30 L and 300 L configurations are designed for direct process transfer from lab-scale development to clinical or commercial manufacturing, supporting platform process strategies under current Good Manufacturing Practice (cGMP) environments.
Key Features
- Patented triple-Rushton impeller configuration with integrated sparger and exhaust manifold—enabling uniform gas dispersion, controlled foam generation, and stable headspace pressure regulation.
- Optimized thermal management via dual-zone jacketing (side + bottom), ensuring precise temperature control (±0.2 °C) without reliance on internal cooling coils that compromise bag integrity.
- Low dead-volume tank geometry with vertical baffle placement—maximizing working volume utilization while minimizing residual holdup during harvest.
- Front-access inspection door with quick-release clamps—facilitating rapid, tool-free installation and visual verification of bag positioning, sensor alignment, and seal integrity.
- Modular cable and tubing management system with color-coded, strain-relieved connectors—reducing entanglement, simplifying maintenance, and enabling reproducible reconfiguration per batch.
- Capacitive foam detection with adaptive thresholding—providing early warning of antifoam overfeed or filter wetting, thereby protecting downstream exhaust filters and preventing process deviation.
Sample Compatibility & Compliance
The HyPerforma SUF supports suspension and adherent mammalian cell cultures (e.g., CHO, HEK293), microbial fermentation (E. coli, Pichia pastoris), and viral vector production (lentivirus, AAV). All single-use components comply with USP and cytotoxicity and extractables testing, and are manufactured under ISO 13485-certified conditions. The system’s architecture aligns with ICH Q5A(R2) and Q5D guidelines for cell line characterization and process consistency. When operated with Thermo Scientific BioProcess Control Software (BPCS), full audit trails, electronic signatures, and data integrity controls meet FDA 21 CFR Part 11 and EU Annex 11 requirements. Validation packages—including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols—are available for GMP audits.
Software & Data Management
The HyPerforma SUF integrates natively with Thermo Scientific BioProcess Control Software (BPCS), a validated, server-based platform supporting real-time monitoring, closed-loop control (pH, DO, temperature, agitation speed, feed rate), and automated event logging. BPCS provides configurable alarm thresholds, trend analysis dashboards, and export functionality compliant with ASTM E2500-13 for raw data archival. All sensor inputs—including analog signals from single-use pH/DO probes and digital outputs from embedded pressure and foam sensors—are timestamped, encrypted, and stored with immutable audit trails. Optional integration with MES (Manufacturing Execution Systems) and LIMS enables seamless batch record generation and electronic batch record (EBR) compliance.
Applications
- Upstream process development and tech transfer from 30 L to 300 L scale.
- Accelerated clinical manufacturing of Phase I–III biologics under cGMP.
- Flexible multiproduct facility operations leveraging shared infrastructure and reduced changeover time.
- Cell and gene therapy (CGT) manufacturing where product-specific contamination control is critical.
- Quality-by-Design (QbD) studies requiring high-resolution parameter mapping (e.g., agitation vs. kLa, sparge rate vs. foam dynamics).
- Regulatory filing support with complete traceability from raw material lot numbers to final harvest data.
FAQ
What materials are used in the single-use bag assembly?
The S.U.F. BPC bag is constructed from multi-layer, USP Class VI-certified polyethylene–polyolefin film with ethylene vinyl alcohol (EVOH) barrier layer, optimized for low leachables, high gas permeability (O2/CO2), and gamma stability up to 50 kGy.
Is the system compatible with existing bioreactor control hardware?
Yes—the HyPerforma SUF interfaces with standard 4–20 mA and RS-485 industrial I/O modules and supports Modbus TCP and OPC UA protocols for third-party SCADA or DCS integration.
How is sensor calibration handled for single-use applications?
Pre-calibrated, factory-trimmed single-use sensors (pH, DO, temperature) are supplied with NIST-traceable calibration certificates; no field recalibration is required prior to use.
Can the 30 L and 300 L systems be operated with identical control parameters?
Yes—dimensionless scaling parameters (e.g., P/V, Njs, tip speed) are preserved across volumes, enabling direct parameter transfer validated per ASTM E2656-20 guidelines.
What documentation is provided for regulatory submissions?
Thermo Scientific supplies a comprehensive validation toolkit including Design Qualification (DQ), Risk Assessment (FMEA), and User Requirement Specification (URS) templates aligned with ICH Q9 and ISO 14971.
