Unimicro EasySep-1010 HPLC System (Analytical & Semi-Preparative)
| Brand | Unimicro Technologies |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Instrument Type | Conventional High-Performance Liquid Chromatograph |
| Model | EasySep-1010 |
| Pump Types | Analytical (10 mL stainless steel head) & Semi-Preparative (50 mL stainless steel head) |
| Flow Range (Analytical) | 0.01–9.99 mL/min |
| Max Pressure (Analytical, SS) | 42 MPa |
| Flow Range (Semi-Prep) | 0.1–49.9 mL/min |
| Max Pressure (Semi-Prep, SS) | 30 MPa |
| Flow Accuracy (Analytical) | RSD ≤ 0.5% at 1 mL/min |
| Flow Precision (Analytical) | RSD ≤ 0.1% at 1 mL/min |
| Flow Accuracy (Semi-Prep) | RSD ≤ 2% at 1 & 10 mL/min |
| Flow Precision (Semi-Prep) | RSD ≤ 0.5% at 1 & 10 mL/min |
| UV-VIS Detector | Wavelength Range 190–360 nm |
| Wavelength Accuracy | ≤ ±1 nm |
| Spectral Bandwidth | 8 nm |
| Wavelength Repeatability | ≤ ±0.1 nm |
| Light Source | DX2 Dual-Life Deuterium Lamp |
| Detector Cell Options | Analytical & Semi-Preparative Flow Cells |
| Display | 320×240 dot-matrix LCD |
| System Protection | Soft-start/stop, programmable pressure limits, auto data backup |
Overview
The Unimicro EasySep-1010 is a modular, dual-purpose high-performance liquid chromatography (HPLC) system engineered for both analytical quantification and semi-preparative purification workflows. Based on classical reversed-phase and normal-phase separation principles, the system employs high-pressure solvent delivery via precision dual-piston reciprocating pumps and UV-Vis detection with wavelength-selective photometry to resolve, identify, and quantify compounds across diverse matrices. Its architecture supports ISO/IEC 17025-compliant method validation and aligns with GLP (Good Laboratory Practice) documentation requirements—making it suitable for regulated environments including pharmaceutical QC laboratories, academic research cores, and contract analytical service providers. Unlike single-role instruments, the EasySep-1010 is designed from the ground up for functional scalability: users may begin with a basic isocratic configuration and incrementally integrate binary or quaternary gradient capability, additional detectors (e.g., conductivity or refractive index), or autosampler modules without hardware replacement.
Key Features
- Modular pump architecture: Interchangeable stainless steel (SS) and PEEK pump heads enable seamless transition between analytical (10 mL head) and semi-preparative (50 mL head) operation—eliminating the need for separate dedicated systems.
- Bio-compatible fluidic path: Optional PEEK pump heads and flow cells minimize metal ion leaching, preserving integrity of sensitive biomolecules (e.g., peptides, monoclonal antibodies, oligonucleotides) during separation.
- High-fidelity solvent delivery: Analytical pump delivers flow accuracy ≤0.5% RSD at 1 mL/min and repeatability ≤0.1% RSD; semi-preparative pump maintains ≤2% RSD accuracy across 1–10 mL/min range—critical for reproducible fraction collection.
- UV-Vis detector with DX2 dual-life deuterium lamp: Offers 190–360 nm wavelength coverage, ±1 nm accuracy, and ≤0.1 nm wavelength repeatability—supporting compliance with USP , EP 2.2.46, and ASTM E2879 standards for detector qualification.
- Intuitive 320×240 LCD interface: Supports multi-step gradient programming with >1,000 line capacity, real-time pressure/flow monitoring, and user-defined alarm thresholds for pressure deviation or lamp exhaustion.
- Embedded system protection logic: Includes soft-start/stop sequencing, programmable upper/lower pressure limits, automatic data retention upon power loss, and 2-minute low-pressure shutdown safeguard.
Sample Compatibility & Compliance
The EasySep-1010 accommodates standard 4.6 mm I.D. analytical columns and 10–21.2 mm I.D. semi-preparative columns using industry-standard fittings (e.g., 10-32 UNF). It supports mobile phases containing aqueous buffers (e.g., ammonium acetate, phosphate), organic modifiers (acetonitrile, methanol), and additives (TFA, formic acid) within its pressure and chemical compatibility envelope. All firmware and data handling protocols are structured to support audit trails, electronic signatures, and secure user access control—enabling alignment with FDA 21 CFR Part 11 requirements when deployed with validated software extensions. The system meets CE marking criteria under Directive 2014/30/EU (EMC) and 2014/35/EU (LVD), and its mechanical design conforms to ISO 13849-1 for safety-related control functions.
Software & Data Management
Control and data acquisition are managed through Unimicro’s proprietary ChromaLink™ software suite (v3.x), compatible with Windows 10/11 64-bit platforms. The software provides full instrument control, real-time chromatogram visualization, peak integration using tangent skim and valley-to-valley algorithms, calibration curve generation (linear, quadratic, weighted), and report export in PDF, CSV, and XML formats. Audit trail functionality logs all method changes, sequence modifications, and user logins with timestamps and operator IDs—essential for GLP audits and internal quality reviews. Raw data files (.uwd) are stored in a non-proprietary hierarchical folder structure, facilitating long-term archival and third-party reprocessing using open-format tools (e.g., Python-based chromatogram parsers).
Applications
- Pharmaceutical QA/QC: Assay and impurity profiling of APIs per ICH Q2(R2) guidelines; stability-indicating method development for forced degradation studies.
- Biopharmaceutical analysis: Size-exclusion chromatography (SEC) of mAbs, ion-exchange analysis of charge variants, and reversed-phase characterization of peptide digests.
- Food & environmental testing: Multi-residue pesticide screening (EN 15662), mycotoxin quantification (aflatoxins, ochratoxin A), and PAH analysis in soil extracts.
- Fine chemical synthesis: Reaction monitoring, chiral separation of intermediates, and purity assessment prior to crystallization or lyophilization.
- Academic research: Method development for novel stationary phases, coupling with mass spectrometry (via post-column splitting), and teaching chromatographic theory in undergraduate analytical chemistry labs.
FAQ
Can the EasySep-1010 be upgraded from analytical to semi-preparative configuration in the field?
Yes—users may replace the 10 mL stainless steel pump head with the 50 mL variant and install a semi-preparative flow cell without requiring factory recalibration or firmware changes.
Does the system support gradient elution with four solvents?
Yes—the quaternary gradient option integrates a proportional high-pressure mixing valve and four independent solvent channels, fully programmable via ChromaLink™ software.
Is the UV detector compliant with pharmacopeial wavelength verification requirements?
Yes—its ±1 nm wavelength accuracy and ≤0.1 nm repeatability satisfy USP and EP 2.2.46 specifications for detector performance qualification.
What data integrity safeguards are built into the software?
ChromaLink™ implements role-based access control, immutable audit trails, electronic signature capture, and automatic backup of method parameters and raw chromatograms—fully traceable to individual operators.
Can PEEK pump heads be used with acidic or basic mobile phases?
PEEK components are chemically resistant to pH 2–12 under standard operating pressures; however, prolonged exposure to >0.1 M strong acids (e.g., TFA >0.5%) or bases >pH 10 is not recommended without validation.
