Agela FLEXA HP100 High-Pressure Preparative Liquid Chromatography System
| Brand | Agela |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | FL-H100G |
| Application Level | Laboratory-Scale |
| Instrument Type | High-Pressure Preparative Liquid Chromatograph |
| Flow Rate Range | 0–100 mL/min |
| Flow Accuracy | ±1 % |
| Maximum Operating Pressure | 20 MPa |
Overview
The Agela FLEXA HP100 is a modular, high-pressure preparative liquid chromatography (PLC) system engineered for reproducible, scalable purification of small molecules, natural products, synthetic intermediates, and early-stage pharmaceutical compounds in laboratory environments. It operates on the fundamental principle of differential partitioning between a mobile phase (typically solvent gradients) and a stationary phase (reversed-phase, silica, or specialty columns), enabling selective retention and elution of target analytes under precisely controlled pressure and flow conditions. With a maximum operating pressure of 20 MPa (2900 psi) and a flow rate range up to 100 mL/min, the HP100 bridges the performance gap between analytical HPLC and mid-scale preparative systems—supporting column diameters from 10 mm to 50 mm ID and accommodating both isocratic and gradient elution methods. Its architecture complies with core engineering requirements for GLP-aligned purification workflows, including pressure stability, flow consistency, and component traceability.
Key Features
- Modular design allowing flexible configuration: independently selectable high-pressure dual-piston pumps, UV/Vis detectors (200–400 nm, 10 mm flow cell), fraction collectors (timed or peak-triggered), autosamplers (up to 120 vials), and multi-column switching valves (up to 6 positions)
- Robust pump system delivering stable flow across full range (0.1–100 mL/min) with ≤±1 % accuracy and low pulsation—critical for baseline stability during extended gradient runs
- Integrated pressure monitoring with real-time feedback control and automatic shutdown at user-defined thresholds (e.g., >20 MPa)
- Chemically resistant fluidic path constructed from stainless steel 316L, PEEK, and sapphire components—compatible with common organic solvents (acetonitrile, methanol, THF) and aqueous buffers (pH 2–8)
- Front-panel touchscreen interface with embedded method storage (≥500 methods), USB export, and optional Ethernet connectivity for remote monitoring
Sample Compatibility & Compliance
The FLEXA HP100 supports purification of diverse compound classes including polar metabolites, lipophilic alkaloids, peptides (<5 kDa), and metal-coordinated complexes—provided they exhibit adequate solubility and chromatographic resolution under standard C18, phenyl-hexyl, or amino-silica phases. Sample loading capacity ranges from microgram to gram scale depending on column dimensions and matrix complexity. The system meets essential functional requirements outlined in ISO 17025 for calibration traceability of flow and pressure transducers. While not pre-certified for FDA 21 CFR Part 11, its software architecture permits integration with validated LIMS or ELN platforms supporting audit trails, electronic signatures, and change control—enabling compliance readiness for GMP-adjacent research labs and contract development organizations.
Software & Data Management
Control and data acquisition are managed via Agela’s FLEXA Control Suite (v3.2+), a Windows-based application supporting method development, real-time chromatogram visualization, peak integration (tangent skim, valley-to-valley), and fraction mapping. Raw data files adhere to ANDI/NetCDF format for interoperability with third-party processing tools (e.g., Chromeleon, OpenChrom). All system events—including method execution, pressure excursions, valve actuations, and fraction collection triggers—are logged with timestamp, operator ID, and checksum-verified metadata. Optional add-ons include automated method validation reports (per ICH Q2(R2) guidelines) and CSV-based batch record generation for regulatory submission packages.
Applications
- Purification of reaction mixtures post-Suzuki coupling or reductive amination to isolate single-isomer products
- Isolation of bioactive constituents from plant extracts (e.g., flavonoids, terpenoids) prior to structural elucidation by NMR or HRMS
- Desalting and buffer exchange of synthetic oligonucleotides prior to enzymatic assays
- Removal of residual catalysts (e.g., Pd, Ru) from API intermediates to meet ICH Q3D elemental impurity limits
- Method scouting for downstream process scale-up—data generated on the HP100 directly informs parameters for pilot-scale SMB or MPLC systems
FAQ
What column formats are compatible with the FLEXA HP100?
Standard stainless-steel or PEEK-packed columns with 1/4″ or 3/8″ fittings, ranging from 10 × 250 mm to 50 × 250 mm (ID × length); custom hardware kits available for guard column integration and in-line filtration.
Can the system perform pH-sensitive separations?
Yes—when paired with pH-stable columns (e.g., wide-pH C18, polymeric reversed-phase) and low-metal-content solvents; system wetted materials avoid catalytic leaching that compromises acidic/basic analytes.
Is remote operation supported?
Via optional Ethernet module and FLEXA Control Suite’s TCP/IP interface—enabling secure access through institutional VPNs for off-site method optimization and run monitoring.
How is flow accuracy verified during qualification?
Using gravimetric measurement per USP Chromatography guidance: collected fractions weighed over ≥5 min intervals at multiple setpoints (10, 50, 100 mL/min), with deviation calculated against theoretical mass based on solvent density.
Does Agela provide installation qualification (IQ) documentation?
Yes—standard IQ/OQ protocol templates (PDF + editable Word) are supplied with each system, aligned with ASTM E2500-13 for analytical instrument lifecycle management.
