Thermo Fisher Vanquish Flex UHPLC System (Domestically Manufactured in Shanghai)
| Brand | Thermo Fisher |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic |
| Model | Vanquish Flex UHPLC System |
| Pricing | Upon Request |
Overview
The Thermo Fisher Vanquish Flex UHPLC System (Domestically Manufactured in Shanghai) is a high-performance, modular ultra-high performance liquid chromatography platform engineered for precision, robustness, and regulatory compliance in pharmaceutical QC, biopharmaceutical characterization, clinical research, and academic analytical laboratories. Built upon the established Vanquish architecture, this domestically manufactured variant retains full functional equivalence to globally supplied Vanquish Flex systems—including identical fluidic design, pressure rating, detector compatibility, and software integration—while meeting localized manufacturing and supply chain requirements. It operates on the fundamental principle of high-pressure liquid separation using sub-2-µm particle-packed columns, enabling superior resolution, sensitivity, and analysis speed compared to conventional HPLC. The system supports pressures up to 1000 bar, facilitating rapid method development and transfer across R&D, QC, and stability testing environments.
Key Features
- SmartFlow Pump Technology: Dual-piston, low-dispersion binary or quaternary gradient pumps with real-time eluent compressibility compensation—ensuring consistent flow accuracy (<±0.05% RSD) and gradient fidelity independent of mobile phase composition or system backpressure.
- SmartInject Autosampler: FT-series autosampler with needle-in-loop injection, 216-position standard tray capacity (expandable to 8832 positions via optional Vanquish Loader), and <0.25% RSD injection precision at volumes ≥1 µL.
- Viper Fingertight Fitting System: Bio-inert, zero-dead-volume, tool-free connections throughout the flow path—compatible with stainless steel, PEEK, and titanium components; certified for use with aggressive solvents and biological matrices.
- Integrated Solvent Monitoring: Real-time solvent level sensing across all channels, with automated pump shutdown and alert generation to prevent dry-run conditions and waste overflow—critical for unattended overnight operation.
- Touchscreen Control Interface: 9-inch capacitive display with intuitive workflow navigation, system diagnostics, and status visualization—supporting local operator interaction without external PC dependency.
Sample Compatibility & Compliance
The Vanquish Flex UHPLC System accommodates a broad range of sample types, including small-molecule APIs, peptides, monoclonal antibodies, oligonucleotides, and complex natural product extracts. Its fully bio-compatible fluidic path—utilizing titanium, PEEKsil, and inert ceramic components—minimizes adsorption and degradation risks for sensitive biomolecules. The system meets essential regulatory requirements for GxP environments: it supports 21 CFR Part 11-compliant electronic records and signatures when operated with Chromeleon CDS v7.3 or later; includes audit trail, user access control, and electronic signature capabilities; and is validated per ICH Q2(R2) guidelines for method suitability. All hardware modules are CE-marked and comply with IEC 61010-1 safety standards.
Software & Data Management
The system is natively integrated with Thermo Scientific Chromeleon Chromatography Data System (CDS) v7.3+, providing end-to-end workflow automation—from sequence setup and instrument control to peak integration, reporting, and data archival. Chromeleon supports Standard Instrument Integration (SII), enabling seamless interoperability with third-party mass spectrometers (e.g., Orbitrap, Q Exactive platforms) and enterprise LIMS or ELN systems. Audit trail functionality logs all user actions, parameter changes, and data modifications with timestamps and operator IDs. Raw data files (.RAW) and processed results are stored in vendor-neutral formats compliant with ASTM E2524 and ISO/IEC 17025 traceability frameworks.
Applications
- Pharmaceutical impurity profiling and stability-indicating assay development (ICH Q5, Q6B)
- Monoclonal antibody charge variant analysis using cation-exchange UHPLC
- Peptide mapping workflows coupled to high-resolution MS detection
- Small-molecule quantification in biological matrices (LC-MS/MS bioanalysis)
- Method transfer from HPLC to UHPLC for accelerated development timelines
- Quality control release testing under GMP-compliant SOPs
FAQ
Is this system functionally identical to the globally manufactured Vanquish Flex?
Yes—the Shanghai-manufactured Vanquish Flex UHPLC system undergoes the same engineering validation, performance qualification, and firmware/software release cycle as its international counterparts.
Does it support FDA 21 CFR Part 11 compliance?
Yes—when configured with Chromeleon CDS v7.3+ and appropriate administrative controls (e.g., role-based permissions, electronic signatures, and audit trail activation).
Can it be integrated with non-Thermo mass spectrometers?
Yes—via Standard Instrument Integration (SII) protocols and vendor-provided API drivers for major LC-MS platforms.
What column chemistries and dimensions are supported?
All commercially available UHPLC columns (1.7–2.6 µm particles) with internal diameters from 2.1 mm to 4.6 mm and lengths up to 150 mm.
Is remote monitoring and control possible?
Yes—Chromeleon CDS supports secure web-based remote access, real-time system health dashboards, and email/SNMP alerting for critical events.
