Waters e2695 HPLC System with 2998 PDA Detector (Refurbished)

Overview

The Waters e2695 HPLC System is a modular, high-performance liquid chromatography platform originally engineered for robustness, regulatory compliance, and method transfer fidelity in pharmaceutical, clinical, and contract research laboratory environments. Built upon the Alliance architecture, the e2695 employs a dual-piston, pulseless quaternary solvent delivery system capable of precise gradient formation across a wide flow rate range (0.001–10.0 mL/min) and pressure capability up to 20 MPa (2900 psi). Its integrated Sample Manager provides low-dead-volume injection with temperature-controlled sample storage (4–40 °C), while the column heater/cooler maintains thermal stability from 4–90 °C—critical for retention time reproducibility and method ruggedness. Coupled with the Waters 2998 Photodiode Array Detector, this system delivers full-spectrum acquisition (190–800 nm) at up to 80 Hz sampling rate, enabling real-time spectral deconvolution, peak purity assessment, and wavelength optimization without re-injection. As a pre-21 CFR Part 11–enabled platform, the e2695 was widely deployed in GLP and early GMP settings and remains fully compatible with Empower 3 software for audit-trail-enabled data acquisition, processing, and reporting.

Key Features

• Modular Alliance architecture supporting seamless integration of solvent manager, autosampler, column oven, and PDA detector
• Quaternary gradient pumping with active solvent proportioning and integrated degassing
• Sample Manager with 120-position vial capacity, programmable injection volume (0.1–100 µL), and adjustable needle wash protocol
• Column heater/cooler with ±0.5 °C temperature accuracy and ramp rate control
• 2998 PDA Detector featuring linear array of 1024 photodiodes, variable slit width (1–8 nm), and real-time spectral library matching
• Empower 3 Software compatibility for method validation, system suitability testing, and electronic signature support
• Fully refurbished and functionally validated per ISO/IEC 17025-aligned internal protocol including pressure leak testing, gradient accuracy verification, and detector linearity calibration

Sample Compatibility & Compliance

The e2695–2998 configuration supports reversed-phase, normal-phase, ion-exchange, and size-exclusion chromatography across diverse sample matrices—including small-molecule APIs, natural product extracts, peptides, and polar metabolites. Its low dwell volume (< 700 µL) and minimized extra-column dispersion ensure compatibility with narrow-bore and UHPLC-compatible columns (down to 2.1 mm ID). All refurbished units undergo comprehensive compliance verification: baseline noise and drift are measured per USP , detection limit is confirmed using caffeine standard (≤ 0.1 ng on-column), and gradient precision is verified per ASTM E2203. While not supplied with 21 CFR Part 11-compliant audit trail enabled by default, the system is fully upgradeable via Empower 3 licensing and meets foundational requirements for FDA-submitted analytical methods referenced in USP monographs and ICH Q2(R2).

Software & Data Management

Operation and data handling are managed through Waters Empower 3 Software (version 3.0 or later), installed and pre-configured on a dedicated Windows workstation. The software provides full instrument control, sequence scheduling, peak integration with customizable algorithms (e.g., valley-to-valley, baseline drop), spectral overlay and purity angle calculation (using both target and reference spectra), and automated system suitability report generation. Raw data files (.raw) are stored in a secure, timestamped hierarchy with embedded metadata (method parameters, instrument logs, user ID). Audit trails are enabled and reviewable; all critical events—including method edits, result reprocessing, and user logins—are time-stamped and immutable. Backups are performed daily to network-attached storage with versioned archive retention.

Applications

This system is routinely applied in QC release testing of pharmaceutical intermediates and finished dosage forms, stability-indicating assay development per ICH Q5C, impurity profiling of synthetic compounds, dissolution testing per USP , and natural product fingerprinting in botanical analysis. Its PDA capability enables co-elution resolution in complex mixtures—such as degradation product identification in forced-stability studies—and facilitates method scouting by rapid spectral interrogation across multiple wavelengths. Laboratories performing extractables/leachables analysis, excipient compatibility screening, or pharmacokinetic bioanalysis also leverage its reproducible retention time control and broad dynamic range (up to 3 AU full-scale absorbance).

FAQ

Is this system compliant with current FDA data integrity expectations?
Yes—when operated with Empower 3 under configured audit trail and electronic signature settings, it satisfies ALCOA+ principles. Full 21 CFR Part 11 readiness requires site-specific validation documentation.
What refurbishment standards are applied prior to shipment?
Each unit undergoes mechanical inspection, fluidic path cleaning and passivation, pressure/leak testing, UV lamp energy calibration, and full-system performance qualification using NIST-traceable standards.
Can I integrate this system with my existing LIMS or CDS?
Yes—the e2695 supports standard ASCII and XML-based data export, and Empower 3 offers ODBC connectivity and RESTful API endpoints for enterprise integration.
Does the 6-month warranty cover labor and parts globally?
Warranty covers functional defects and includes remote diagnostics and on-site service within North America, Europe, and select APAC regions; extended coverage options are available.
Are original manufacturer manuals and certificates included?
Yes—all delivered units include digitized operation manuals, maintenance guides, factory calibration certificates, and a SpectraLab Refurbishment Certificate of Conformance.