Waters ACQUITY UPLC System (Refurbished)

Overview

The Waters ACQUITY UPLC System is a high-pressure, high-resolution liquid chromatography platform engineered for precision separations under ultra-high performance conditions. Built upon the principles of small-particle chromatography (<2 µm particles) and elevated system pressure capability (up to 15,000 psi), this refurbished instrument delivers significantly enhanced resolution, speed, and sensitivity compared to conventional HPLC systems. Its core architecture integrates a low-dispersion binary solvent manager, a high-reproducibility sample manager with needle-in-loop injection, and a column manager capable of precise thermal control (ambient to 90 °C). The system is designed for use in regulated environments—particularly pharmaceutical QC/QA, environmental residue analysis, and food safety testing—where method robustness, data integrity, and compliance with analytical validation requirements are essential.

Key Features

• Refurbished and fully functionally tested by certified technicians to meet original Waters performance specifications.
• High-pressure gradient pumping system with active solvent compressibility compensation for improved flow accuracy and retention time stability.
• Low-volume, low-dead-volume fluidic path minimizing band broadening and maximizing peak capacity.
• Autosampler with wash-port and needle seal cleaning options to reduce carryover and ensure long-term reproducibility.
• Column oven with rapid thermal equilibration and uniform temperature distribution across multiple column configurations.
• Modular design supporting integration with UV/Vis, photodiode array (PDA), or mass spectrometry (MS) detectors via standardized analog/digital I/O and LC-MS synchronization protocols.
• Compliance-ready firmware architecture compatible with Empower 3 software for audit trail, electronic signature, and 21 CFR Part 11 functionality (subject to software licensing and configuration).

Sample Compatibility & Compliance

The ACQUITY UPLC accommodates a wide range of sample matrices—including aqueous, organic, and mixed-solvent extracts—from pharmaceutical actives, environmental water extracts, pesticide residues, and complex biological fluids. It supports reversed-phase, hydrophilic interaction (HILIC), ion-exchange, and size-exclusion chromatographic modes when paired with appropriate columns. All refurbished units undergo full IQ/OQ verification per ASTM E2500 and ISO/IEC 17025-aligned procedures. Documentation packages include calibration records, system suitability test results, and traceable maintenance logs. The platform is routinely deployed in laboratories adhering to USP , ICH Q2(R2), and FDA guidance on analytical method validation.

Software & Data Management

Operation and data acquisition are managed through Waters Empower Chromatography Data Software (CDS), with support for both Empower 3 Feature Release 2 (or later) and legacy Empower 2 installations depending on system configuration. The software provides comprehensive tools for method development, sequence definition, real-time monitoring, peak integration, and report generation. Audit trail functionality captures all user actions—including method edits, result modifications, and reprocessing events—with timestamps and operator identification. Data files are stored in secure, encrypted project databases compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Raw data export formats include .raw, .cdf, and .csv for third-party analysis or regulatory submission.

Applications

• Pharmaceutical impurity profiling and assay quantitation per ICH guidelines.
• Residual solvent analysis in drug substances using headspace-GC coupling or direct UPLC-UV methods.
• Environmental monitoring of polar contaminants (e.g., PFAS, pharmaceuticals in wastewater) requiring high-resolution separation and low detection limits.
• Food allergen marker detection and mycotoxin screening in cereals, dairy, and infant formula.
• Biopharmaceutical characterization—including monoclonal antibody subunit analysis and glycan mapping—when interfaced with MS detectors.
• Academic and contract research laboratories performing method transfer, stability-indicating assay development, or high-throughput screening.

FAQ

Is this unit covered by a manufacturer warranty?
No. As a refurbished instrument sourced through an independent distributor, it carries a 6-month limited hardware warranty covering defects in materials and workmanship.
Can this system be validated for GMP use?
Yes. Each unit ships with IQ/OQ documentation templates and test reports. Full 3Q validation (including PQ) must be performed by the end-user laboratory in accordance with internal SOPs and regulatory expectations.
What software version is included?
Empower 3 FR2 (or latest compatible release at time of refurbishment) is pre-installed; license status and upgrade eligibility depend on Waters’ current entitlement policy and require direct coordination with Waters support.
Are consumables and spare parts available?
All standard ACQUITY UPLC consumables—including seal kits, frits, check valves, and column hardware—are commercially available from Waters and authorized distributors worldwide.
Does the system include a detector?
Detector configuration varies per unit. Common options include the ACQUITY UV/Vis Detector, PDA Detector, or TUV Detector. MS interface capability is retained but requires separate MS instrumentation.