Thermo Scientific HyPerforma SUM Single-Use Mixer
| Brand | Thermo Scientific |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Import Status | Imported |
| Model | HyPerforma SUM |
| Instrument Category | Mixing & Homogenization Equipment |
| Volumes Available | 50 L, 100 L, 200 L, 500 L, 1,000 L, 2,000 L |
| Motor Options | AC or Brushless DC with Encoder Feedback |
| Temperature Control | Non-jacketed or Water-jacketed (side & bottom) |
| Weighing System | Triple-load-cell integrated scale |
| Sensor Integration | Temperature, pH, Conductivity, Pressure |
| Film Options | CX5-14 and Aegis5-14 single-use bioprocess containers (BPCs) |
| Sterile Port Configuration | Fill, drain, sampling, vent, and aseptic connection ports |
| Compliance | Designed for cGMP environments |
Overview
The Thermo Scientific™ HyPerforma™ SUM (Single-Use Mixer) is an engineered platform for scalable, sterile mixing in biopharmaceutical manufacturing—designed to replace stainless-steel vessels in both upstream and downstream unit operations. Operating on the principle of top-driven mechanical agitation within a disposable bioprocess container (BPC), the HyPerforma SUM delivers consistent shear profiles, uniform mass transfer, and controlled gas exchange without compromising container integrity or sterility. Its modular architecture supports process intensification strategies including powder hydration, buffer dilution, harvest hold, viral inactivation, intermediate blending, and final formulation—enabling seamless transition from clinical-scale batches to commercial production. The system’s core design philosophy centers on operational robustness, operator ergonomics, and regulatory alignment: all wetted surfaces are single-use, eliminating cleaning validation burdens while maintaining precise rotational control via brushless DC or AC motor options with real-time RPM feedback.
Key Features
- Patented top-drive agitator mechanism that maintains BPC seal integrity and sterility during operation—no rotating seals or shaft penetrations required.
- Ergonomic vertical access door (standard on 500 L, 1,000 L, and 2,000 L models) enabling rapid, tool-free installation and removal of single-use bags.
- Integrated triple-load-cell weighing system with ±0.1% full-scale accuracy, supporting real-time mass tracking and gravimetric feed control.
- Flexible thermal management: non-jacketed configuration for ambient or external heat-exchanger integration, or full water-jacketed design (side + bottom) compatible with external chillers/heaters.
- Dedicated cable and tubing management frame—reducing entanglement risk, simplifying CIP/SIP preparation, and improving cleanroom workflow efficiency.
- Modular tool rack with height-adjustable mounting points for pipettes, probes, clamps, and calibration devices—optimized for ALCOA+ compliant documentation practices.
- Electrical interface includes factory-ready communication cables (e.g., 4–20 mA, RS-485, Ethernet/IP) for integration into distributed control systems (DCS) or SCADA platforms.
- Motor options include AC induction for high-torque low-RPM applications or brushless DC with encoder feedback for ±0.5 RPM repeatability across 10–150 rpm range (dependent on volume and impeller geometry).
Sample Compatibility & Compliance
The HyPerforma SUM is qualified for use with industry-standard single-use bioprocess containers, including Thermo Scientific CX5-14 and Aegis5-14 films—both tested per USP , ISO 10993-5/10, and extractables/leachables protocols (E&L) per ICH Q5A(R2) and BioPhorum standards. All contact materials comply with USP Class VI and FDA 21 CFR 177.2600 requirements. The system meets mechanical safety standards per IEC 61000-6-2/6-4 and is designed for installation in ISO Class 5–8 environments. When paired with validated control software (e.g., Thermo Fisher Connect or third-party MES), it supports audit trails, electronic signatures, and change control per 21 CFR Part 11 and EU Annex 11. Process validation packages—including mixing time, homogeneity, oxygen transfer rate (kLa), and temperature uniformity studies—are available upon request.
Software & Data Management
Data acquisition and control are managed via an embedded controller with configurable analog/digital I/O and optional HMI panel. Real-time parameters—including RPM, weight, temperature, pH, conductivity, pressure, and motor current—are logged at user-defined intervals (minimum 1-second resolution) and exported in CSV or ASTM E1384-compliant formats. Alarm thresholds, interlocks (e.g., over-torque shutdown, low-level weight cutoff), and batch event tagging are fully programmable. For enterprise integration, OPC UA and MQTT protocols support secure bidirectional communication with LIMS, MES, and digital twin platforms. All electronic records maintain immutable timestamps, operator IDs, and revision history—fully traceable for GLP/GMP audits.
Applications
- Powdered media and buffer hydration under controlled shear to prevent foaming and particle aggregation.
- Dilution of concentrated cell culture media with precise gravimetric dosing and mixing time optimization.
- Harvest hold tanks for clarified bioreactor broth prior to chromatography—maintaining viability and stability via temperature-controlled agitation.
- Viral inactivation steps requiring homogeneous mixing of low-pH or solvent/detergent reagents at defined residence times.
- Downstream intermediate blending (e.g., eluate pooling, formulation buffer addition) with strict adherence to hold time and temperature specifications.
- Final drug substance storage and additive suspension (e.g., polysorbate 80, human serum albumin) where minimal dead volume and complete emptying are critical for yield recovery.
FAQ
What single-use bag films are qualified for use with the HyPerforma SUM?
CX5-14 and Aegis5-14 films from Thermo Scientific are fully qualified; compatibility with other vendor films requires joint qualification per ASTM F2714 and user-specific risk assessment.
Is the HyPerforma SUM suitable for GMP manufacturing environments?
Yes—the system is designed and documented to support cGMP operations, including IQ/OQ protocols, material traceability, and change control documentation.
Can the mixer be integrated into an automated process train?
Yes—via standard industrial communication protocols (OPC UA, Modbus TCP, Ethernet/IP) and configurable digital I/O for interlocking with pumps, valves, and sensors.
What is the typical mixing time for a 1,000 L buffer dilution step?
Under standard operating conditions (120 rpm, pitched-blade impeller, 25°C), homogeneity (RSD <5% conductivity) is typically achieved within 12–18 minutes; exact values depend on fluid rheology and initial concentration gradient.
Does the system support temperature control during mixing?
Yes—either through external jacketed heat exchangers connected to the water-jacketed vessel or via immersion probes coupled to independent thermal control units.
