Unimicro EasySep®3050PLC Preparative High-Performance Liquid Chromatography System

Overview

The Unimicro EasySep®3050PLC is a fully integrated preparative high-performance liquid chromatography (HPLC) system engineered for scalable purification of organic compounds, natural products, peptides, and small-molecule pharmaceuticals. Built upon robust dual-piston reciprocating pump architecture, it delivers precise, pulse-free solvent delivery across a wide flow range—up to 50 mL/min—enabling seamless transition from analytical method development to gram-scale isolation. Its modular design supports both isocratic and gradient elution, with pressure stability maintained up to 42 MPa (6090 psi), ensuring compatibility with sub-5 µm particle-packed preparative columns and core-shell media. The system operates under ISO/IEC 17025-aligned engineering practices and is designed to meet the operational rigor required in QC laboratories, process R&D, and GLP-compliant purification workflows.

Key Features

• High-precision binary or quaternary solvent delivery system with flow accuracy < 0.06% RSD, validated per ASTM E260 and USP <621> guidelines.
• Integrated column oven with active air-circulation heating and cooling, maintaining temperature uniformity ±0.5 °C across the 5–100 °C operating range—critical for retention time reproducibility in multi-day purification campaigns.
• Standard dual-wavelength UV-Vis detector featuring deuterium and tungsten lamp sources, covering 190–800 nm with real-time spectral acquisition at 20 Hz—supporting peak purity assessment and fraction-triggered collection.
• Modular detector interface accommodating optional DAD, fluorescence (FLD), evaporative light scattering (ELSD), and mass spectrometry (MS) detectors via standardized analog/digital I/O and Ethernet-based communication protocols.
• Autosampler with 24-position 10 mL vial capacity, programmable injection volumes from 0.1 to 10 mL in 0.1 µL increments, and needle wash station with dual-solvent capability to minimize carryover.
• Integrated fraction collector with timed, peak-based, or threshold-triggered collection modes, supporting 12–96-tube configurations and customizable tube rack geometry.

Sample Compatibility & Compliance

The EasySep®3050PLC accommodates diverse sample matrices—including crude extracts, reaction mixtures, fermentation broths, and synthetic intermediates—across reversed-phase (C18, C8, phenyl), normal-phase (silica, cyano), and ion-exchange chemistries. Its fluidic path employs biocompatible wetted materials (316L stainless steel, PEEK, sapphire, and fused silica), minimizing adsorption and metal leaching. System validation documentation supports IQ/OQ/PQ execution per FDA 21 CFR Part 11 requirements, including electronic signature support, audit trail logging, and user-access-level configuration control. All hardware components comply with CE, RoHS, and IEC 61010-1 safety standards.

Software & Data Management

Unimicro ChromStation software provides full bidirectional control of all modules—including pump, detector, autosampler, column oven, and fraction collector—through a unified graphical interface. It supports method development workflows with gradient editor, peak integration using ISO 11095-compliant algorithms, and customizable reporting templates compliant with ALCOA+ data integrity principles. Raw data are stored in vendor-neutral .CDF format (compatible with OpenLab CDS, Chromeleon, and Empower), while audit trails are encrypted and timestamped with SHA-256 hashing. Remote monitoring via HTTPS-enabled web interface allows secure access from laboratory networks without exposing internal infrastructure.

Applications

• Purification of synthetic APIs and impurity reference standards in accordance with ICH Q5 and Q7 guidance.
• Isolation of bioactive natural product fractions for structure elucidation (NMR, HRMS) and biological screening.
• Desalting and buffer exchange of oligonucleotides and peptides prior to lyophilization or formulation studies.
• Chiral separation of enantiomers using polysaccharide-based preparative columns under SFC or HPLC conditions.
• Process optimization of chromatographic steps in continuous manufacturing environments, supported by real-time fraction analytics integration.

FAQ

What is the maximum column backpressure the EasySep®3050PLC can sustain during extended operation?
The system is rated for continuous operation at up to 42 MPa (6090 psi), with pressure sensors calibrated and verified annually per ISO/IEC 17025-accredited procedures.
Can the UV-Vis detector perform simultaneous dual-wavelength quantitation without spectral scanning?
Yes—the detector supports independent, real-time absorbance measurement at two user-defined wavelengths (e.g., 214 nm and 254 nm) with no duty cycle penalty or signal averaging delay.
Is method transfer from analytical to preparative scale supported in ChromStation?
ChromStation includes a scale-up calculator that applies linear velocity and column volume scaling rules per USP <621> Chapter, enabling direct translation of gradient profiles and flow rates between analytical (4.6 mm ID) and preparative (20–50 mm ID) columns.
Does the system support 21 CFR Part 11 compliance out-of-the-box?
Yes—electronic signatures, role-based access control, immutable audit trails, and data encryption are enabled by default and configurable during initial setup per organizational SOPs.