Waters 2695 Separations Module (Used, Refurbished HPLC System)

Overview

The Waters 2695 Separations Module is a robust, modular high-performance liquid chromatography (HPLC) system originally engineered for method development, quality control, and routine analytical applications in regulated pharmaceutical, environmental, and food safety laboratories. Based on Waters’ proven Alliance architecture, the 2695 employs low-dead-volume quaternary gradient pumping (0.001–10.000 mL/min, ≤0.1% RSD flow precision), precise temperature-controlled autosampling (±0.5 °C stability), and a dual-beam UV-Vis detector with real-time baseline correction. This refurbished unit undergoes full mechanical and electronic validation—including pump linearity, injector carryover (<0.01%), detector noise (<±0.5 mAU), and system dwell volume verification—prior to deployment. It is not a “used-only” instrument but a factory-refurbished system requalified per Waters’ Service Technical Bulletin TB-001-05, ensuring performance alignment with original OEM specifications under ISO/IEC 17025 traceable calibration protocols.

Key Features

• Quaternary solvent delivery system with pulse-free flow, programmable gradient profiles (0–100% B in 0.1% increments), and integrated degasser
• Autosampler with 21-position vial capacity, 100 µL fixed-loop injection (optional 1–1000 µL variable loop upgrade), and needle wash station
• Column compartment with Peltier-based temperature control (ambient to 60 °C, ±0.5 °C stability), accommodating up to two 250 mm columns
• Variable Wavelength Detector (VWD) featuring 190–700 nm spectral range, 1 nm wavelength accuracy, and <0.001 AU/h baseline drift
• Modular design supporting future integration of additional detectors (e.g., fluorescence, conductivity) or auxiliary modules (e.g., fraction collector)
• Refurbishment includes replacement of all high-wear components: piston seals, check valves, rotor seals, lamp, and flow cell; full firmware update to latest stable release

Sample Compatibility & Compliance

The Waters 2695 supports reversed-phase, normal-phase, ion-exchange, and size-exclusion chromatography across diverse matrices—including small-molecule APIs, residual solvents, pesticide residues, organic acids, and natural product extracts. Its hardware meets mechanical and operational prerequisites for compliance with pharmacopeial methods (USP , EP 2.2.46, JP 6.03), EPA Method 8081B/8270D, and ISO 17025-accredited testing workflows. All refurbished units ship with a Certificate of Refurbishment and a complete System Suitability Test Report (SSTR) documenting peak symmetry (Asymmetry Factor ≤1.5 @ 10% height), resolution (Rs ≥2.0 for critical pairs), and tailing factor (Tf ≤1.5) using certified NIST-traceable standards.

Software & Data Management

The system operates natively with Waters Empower 2 or Empower 3 (in legacy compatibility mode), supporting audit trail-enabled data acquisition, processing, and reporting. Full 21 CFR Part 11 compliance is achievable when deployed with validated Empower configurations—including electronic signatures, user role-based access control, and immutable audit logs. Raw data (.raw files) are fully interoperable with third-party processing tools (e.g., Chromeleon, OpenLab CDS) via AIA/ANDI export. All units include licensed software media, activation keys, and installation support documentation—but do not include perpetual software maintenance; optional annual support contracts available upon request.

Applications

• Pharmaceutical QC: Assay, related substances, dissolution testing, and stability-indicating method execution per ICH Q2(R2)
• Environmental analysis: PAHs, PCBs, chlorinated pesticides, and emerging contaminants in water/soil extracts
• Food & beverage: Mycotoxin quantification (aflatoxins, ochratoxin A), preservative profiling (sorbates, benzoates), and vitamin analysis
• Academic & contract research: Method scouting, column screening, and preparative-scale method transfer
• Biopharma support: Peptide mapping, excipient characterization, and residual host-cell protein detection (when coupled with appropriate columns/detectors)

FAQ

Is this system qualified for GMP-regulated environments?
Yes—each unit undergoes IQ/OQ documentation per ASTM E2500 and includes a full SSTR. Final PQ must be performed by the end user in their operational context.
What detector options were originally available with the 2695 platform?
Standard configuration includes the VWD; optional upgrades included the 2487 Dual λ Absorbance Detector, 2489 UV/Vis Detector, or 2475 Multi λ Fluorescence Detector.
Can this system be upgraded to UPLC performance?
No—the 2695 is an HPLC-grade platform with maximum pressure rating of 5,000 psi; UPLC-capable systems require the ACQUITY family (e.g., ACQUITY UPLC H-Class).
Does the refurbishment include column oven calibration verification?
Yes—temperature uniformity and ramp rate are verified across the full operating range using NIST-traceable thermocouple probes.
Is method transfer from older Alliance systems supported?
Yes—method parameters (flow rates, gradients, detection wavelengths) are directly portable; minor retention time shifts may occur due to column aging or mobile phase composition and require re-optimization.