Xiangyi VORTEX 22K High-Capacity High-Speed Refrigerated Centrifuge

Overview

The Xiangyi VORTEX 22K is a floor-standing, high-capacity, refrigerated centrifuge engineered for demanding separation tasks in biopharmaceutical manufacturing, academic research, and clinical diagnostics laboratories. It operates on the principle of sedimentation under controlled gravitational force (RCF), enabling efficient isolation of biomolecules—including plasmids, viral vectors, exosomes, and subcellular organelles—based on differences in density, size, and shape. With a maximum rotational speed of 22,000 rpm and a peak relative centrifugal force of 52,020 × g, the VORTEX 22K delivers reproducible, scalable separations across both angle and horizontal rotor configurations. Its integrated refrigeration system maintains precise temperature control from –20 °C to +40 °C during operation, minimizing thermal denaturation of heat-sensitive biological samples. The unit complies with foundational design expectations for Good Manufacturing Practice (GMP) environments, including secure data integrity, traceable operational history, and hardware-level safety interlocks.

Key Features

• Intelligent remote management: Monitor and control up to 100 units simultaneously via Ethernet-connected PC or dedicated mobile application; supports real-time status display, start/stop commands, and secure authentication.
• Automated motorized lid with anti-pinch detection: Eliminates manual handling risks and ensures consistent sealing integrity before acceleration.
• Multi-layer safety architecture: Includes rotor auto-recognition, imbalance detection, overspeed cutoff, overtemperature shutdown, motor thermal protection, and lid interlock verification.
• High-integrity rotor construction: Angle and horizontal rotors fabricated from aerospace-grade 7075-T6 aluminum alloy, titanium, or carbon fiber—each certified with full material traceability (chemical composition, tensile strength, non-destructive ultrasonic testing, anodization thickness).
• Durable chamber design: 316L stainless steel inner chamber (2 mm wall thickness), corrosion-resistant and compliant with ISO 13485 cleanroom-compatible surface finish standards.
• Precision acceleration/deceleration profiling: 10 programmable ramp-up and 11 ramp-down curves to prevent sample resuspension and optimize pellet integrity.
• Efficient workflow integration: Stores up to 100 user-defined protocols with alphanumeric (Pinyin-enabled) naming; supports 5-step gradient runs (speed/time/temperature) with single-button activation.

Sample Compatibility & Compliance

The VORTEX 22K accommodates a broad range of sample containers—from 0.2 mL PCR tubes to 750 mL disposable bottles—via interchangeable rotors (e.g., 6 × 500 mL angle rotor, 4 × 750 mL horizontal rotor). It is routinely employed in applications requiring adherence to USP , ISO 20395 (biomolecular quantification), and ICH Q5A (viral clearance validation). All operational parameters—including run time, setpoint temperature, actual RCF, rotor ID, and error logs—are timestamped and stored locally with optional export to LIMS or MES systems. Data recording meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and supports FDA 21 CFR Part 11 compliance when deployed with validated software controls and electronic signature modules.

Software & Data Management

The embedded control system provides a standardized Modbus TCP and OPC UA–compatible Ethernet interface, enabling seamless integration into centralized laboratory automation platforms. Critical process variables—including actual vs. setpoint temperature, real-time RCF, cumulative rotor lifetime (in hours and cycles), and door status—are exposed via documented tag mapping. Audit trails retain all user actions, parameter changes, and alarm events with immutable timestamps. Export formats include CSV and XML, compatible with third-party analytics tools. Optional firmware upgrades support enhanced cybersecurity features, including TLS 1.2 encryption for remote sessions and role-based access control (RBAC) configuration.

Applications

• Large-volume cell harvesting and clarification in upstream bioprocessing (e.g., CHO, HEK293 suspension cultures)
• Downstream purification of monoclonal antibodies, mRNA-LNPs, and AAV vectors
• Isolation of extracellular vesicles (EVs) and exosomes from plasma, serum, or conditioned media
• Preparative ultracentrifugation of ribosomes, nucleic acid complexes, and membrane fractions
• Quality control testing in vaccine production, including residual host cell DNA and protein assays
• Environmental microbiology workflows requiring high-throughput water or soil extract processing

FAQ

Does the VORTEX 22K support 21 CFR Part 11-compliant electronic records?

Yes—when paired with validated software configuration and appropriate administrative controls (e.g., password policies, audit trail review procedures), the system satisfies core requirements for electronic signatures and record retention.
What rotor certifications are provided with each unit?

Each rotor includes full traceability documentation: material certificate (EN 10204 3.1), tensile test report, chemical composition analysis, ultrasonic inspection report, and hard-anodization thickness verification.
Can the centrifuge be integrated into a SCADA or MES environment?

Yes—the standard Ethernet port supports Modbus TCP and OPC UA protocols; tag lists and communication specifications are supplied upon request.
Is the 316L stainless steel chamber independently verified?

Yes—a certified mill test report (MTR) for the chamber material is included with delivery.
How is rotor lifetime tracked and managed?

The onboard controller logs cumulative operating hours and acceleration cycles per rotor ID; alerts trigger at predefined service thresholds to support preventive maintenance planning.