Unimicro EasySep®-5010 Ultra-High Performance Liquid Chromatograph (UHPLC)

Overview

The Unimicro EasySep®-5010 is an ultra-high performance liquid chromatograph engineered for robust, reproducible, and high-resolution separations in routine and research-grade laboratories. Built upon a quaternary solvent delivery architecture, the system delivers precise gradient formation by independently controlling four mobile phase solvents—enabling complex method development, method transfer, and multi-analyte quantitation without manual solvent switching. Its hydraulic design complies with ISO 13485–aligned manufacturing protocols and supports operation across standard HPLC and UHPLC pressure regimes, with a maximum system pressure rating of 68 MPa (9,860 psi), compatible with sub-2 µm particle-packed columns and superficially porous particle (SPP) columns. The system integrates seamlessly into regulated environments, supporting audit trails, electronic signatures, and data integrity frameworks aligned with FDA 21 CFR Part 11 and EU Annex 11 requirements when deployed with validated software configurations.

Key Features

• Quaternary low-pulsation solvent delivery system with dual parallel piston pumps, delivering flow rate accuracy ≤ ±0.2% RSD and gradient precision ≤ ±0.15% absolute over 0.01–5.00 mL/min range
• Autosampler with 120-position refrigerated sample tray (4–40 °C), 10 µL minimum injection volume, and needle wash station with dual solvent capability to minimize carryover (<0.005% typical)
• Column oven with temperature control from ambient +5 °C to 80 °C (±0.1 °C stability), accommodating up to two 150 mm columns or one 300 mm column with integrated pressure monitoring
• UV/Vis photodiode array detector (PDA) with 190–800 nm spectral range, 1 nm resolution, and real-time peak purity assessment algorithms
• Modular chassis design supporting future expansion with optional fluorescence, conductivity, or mass spectrometry interfaces via standardized LC-MS coupling ports

Sample Compatibility & Compliance

The EasySep®-5010 accommodates a broad range of sample matrices—including pharmaceutical actives, small-molecule metabolites, natural product extracts, polymer additives, and environmental contaminants—without requiring hardware modification. It supports reversed-phase, normal-phase, hydrophilic interaction (HILIC), and ion-exchange chromatographic modes. Column compatibility spans 2.1–4.6 mm ID and 30–250 mm length, including narrow-bore and capillary formats. All fluidic pathways employ biocompatible stainless steel and PEEK-lined components rated for pH 1.5–12.0. The system meets IEC 61010-1 safety standards and conforms to electromagnetic compatibility (EMC) directives per EN 61326-1. For GxP laboratories, full IQ/OQ documentation packages are available, and hardware firmware supports GLP/GMP-compliant operation with timestamped event logging and user-access-level permissions.

Software & Data Management

Controlled by Unimicro’s ChromaDB™ workstation—a database-driven, SQL-based chromatography data system—the EasySep®-5010 enables centralized method storage, version-controlled sequence management, and automated report generation compliant with ASTM E2500 and USP . ChromaDB™ provides full 21 CFR Part 11 compliance out-of-the-box, including role-based access control, electronic signature workflows, and immutable audit trails for all acquisition, processing, and reporting actions. Raw data files are stored in vendor-neutral .cdf format (compatible with AIA/ANDI standards), ensuring long-term archival integrity and third-party software interoperability. Optional integration with LIMS platforms (e.g., LabVantage, Thermo SampleManager) is supported via HL7 and RESTful API interfaces.

Applications

The EasySep®-5010 serves as a primary analytical platform in QC/QA laboratories for dissolution testing, content uniformity, assay validation, and stability-indicating methods per ICH Q2(R2). It is routinely deployed in academic and industrial research for pharmacokinetic profiling, impurity identification, chiral separation (with compatible chiral columns), and peptide mapping. Environmental labs utilize its high-pressure capability for EPA Method 8330B (PAHs), 8082A (PCBs), and ISO 17993-compliant pesticide residue analysis. In food safety, it supports detection of mycotoxins, sweeteners, and preservatives per AOAC 2012.01 and EU Commission Regulation (EC) No 401/2006.

FAQ

Is the EasySep®-5010 compatible with mass spectrometry detectors?
Yes—the system features standard ESI and APCI interface ports, pressure-rated capillary connections, and synchronized timing signals for seamless LC-MS coupling.
Does the autosampler support micro-volume vials and 96-well plates?
It accepts 1.5 mL screw-thread vials, 2 mL push-in vials, and 96-well microtiter plates (SBS footprint) with optional plate carrier upgrade.
Can ChromaDB™ be validated for use in FDA-regulated facilities?
Yes—Unimicro provides comprehensive validation documentation (URS, FRS, DQ/IQ/OQ/PQ protocols) and on-site qualification support for 21 CFR Part 11 and Annex 11 compliance.
What maintenance intervals are recommended for pump seals and detector lamps?
Pump seal replacement is advised every 6,000 operational hours; deuterium and tungsten lamp lifetimes are rated at ≥2,000 and ≥5,000 hours respectively, with real-time usage tracking in ChromaDB™.
Is remote monitoring and troubleshooting supported?
Yes—via secure TLS-encrypted web interface and optional Unimicro Remote Assist module, enabling diagnostics, firmware updates, and collaborative troubleshooting under ITAR- and GDPR-compliant data handling policies.