Waters Alliance 2695 HPLC System with 2998 PDA, 2414 RI, and Fraction Collector III

Overview

The Waters Alliance 2695 is a high-performance, modular high-pressure liquid chromatography (HPLC) system engineered for robustness, reproducibility, and method transfer compatibility across QC, R&D, and regulatory environments. Designed around a dual-piston parallel-flow solvent delivery architecture, it delivers precise gradient formation and low pulse amplitude across flow rates from 0.001 to 10 mL/min. This refurbished system integrates three core detection modalities: the Waters 2998 Photodiode Array (PDA) Detector for full-spectrum UV-Vis characterization (190–800 nm, 1 nm resolution), the Waters 2414 Refractive Index (RI) Detector for universal, non-destructive quantification of non-UV-absorbing analytes (e.g., sugars, polymers), and the Fraction Collector III for automated, time- or peak-triggered collection of eluting fractions—enabling offline MS, NMR, or bioactivity analysis. All modules undergo comprehensive functional validation—including baseline noise, drift, wavelength accuracy, injection precision (RSD < 0.3%), and gradient dwell volume verification—prior to release.

Key Features

• Refurbished Alliance 2695 Separations Module: Includes quaternary solvent manager, column heater/cooling compartment (5–85 °C), and integrated sample manager with 100-position vial capacity and 0.1 µL minimum injection volume.
• 2998 PDA Detector: Equipped with deuterium/tungsten lamp source, real-time spectral acquisition (up to 80 Hz), and peak purity assessment algorithms compliant with USP and ICH Q2(R2) guidelines.
• 2414 RI Detector: Temperature-controlled flow cell (±0.01 °C stability), linear dynamic range >10⁴, compatible with THF, chloroform, and aqueous mobile phases—validated per ASTM D5296 for polymer molecular weight distribution analysis.
• Fraction Collector III: Supports 96-well plates, test tubes, or custom racks; programmable by time, volume, or UV threshold; includes leak detection and position calibration routines.
• System-wide firmware updated to Empower 3 Feature Release 3 (FR3) compatibility; all hardware interfaces verified for bidirectional communication and event logging.

Sample Compatibility & Compliance

This configuration supports reversed-phase, normal-phase, HILIC, size-exclusion, and ion-exchange chromatographic methods. It accommodates columns up to 300 mm in length and internal diameters from 2.1 mm to 4.6 mm, with pressure capability up to 5000 psi. All refurbished units comply with ISO 9001:2015 quality management requirements for reconditioned instrumentation. Operational documentation includes Certificate of Functional Verification, detector linearity reports (NIST-traceable standards), and system suitability test (SST) templates aligned with FDA 21 CFR Part 11 data integrity expectations. Audit trails, electronic signatures, and user access controls are fully enabled within Empower 3 software when deployed in validated environments.

Software & Data Management

The system operates natively with Waters Empower 3 Chromatography Data Software (CDS), supporting both Client/Server and Single-User deployments. Data acquisition, processing, reporting, and archiving adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Raw data (.raw files) and processed results are stored with embedded metadata—including instrument ID, method version, operator ID, and timestamped audit events. Backup and restore procedures follow NIST SP 800-88 Rev. 1 guidelines. Optional integration with LIMS via ASTM E1578-compliant interfaces is supported.

Applications

• Pharmaceutical QC: Assay, related substances, dissolution testing, and extractables/leachables profiling per USP , , and ICH Q5C.
• Food & Beverage: Quantification of sweeteners (sucrose, fructose), organic acids, preservatives, and mycotoxins using dual-detection confirmation.
• Polymers & Materials Science: Gel permeation chromatography (GPC) with RI detection for Mn, Mw, and dispersity (Đ) determination—validated against NIST SRM 1475a.
• Natural Products & Botanicals: Multi-wavelength PDA-based fingerprinting and peak tracking across complex extracts.
• Academic & Method Development Labs: Platform for orthogonal detection method development, column screening, and forced degradation studies.

FAQ

Is this system eligible for IQ/OQ/PQ protocol support?
Yes—SpectraLab Scientific provides customizable installation qualification (IQ) and operational qualification (OQ) documentation packages, including test scripts, acceptance criteria, and execution records traceable to ASTM E2500 and EU Annex 15.

Can the system be configured for GMP-regulated environments?
All refurbished Alliance 2695 systems ship with Empower 3 FR3 pre-installed and configured for 21 CFR Part 11 compliance, including electronic signature workflows, role-based permissions, and immutable audit trails.

What validation documentation is included?
Each unit ships with a Certificate of Functional Verification, detector calibration reports (PDA wavelength accuracy ±0.5 nm, RI linearity R² ≥ 0.9999), injection precision data (n = 6, RSD ≤ 0.25%), and system pressure stability logs over 24 hours.

Is extended warranty or service contract available?
Yes—annual preventive maintenance contracts include on-site technician visits, spare parts coverage, firmware updates, and priority remote diagnostics support.

Are original manufacturer manuals and software licenses provided?
Full digital archives of Waters Alliance 2695 hardware manuals, Empower 3 user guides, and valid software license certificates (with transfer authorization) are supplied with each system.