Waters 2695 Separations Module HPLC System (Refurbished, 90% Condition)
| Brand | Waters |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Import Status | Imported |
| Model | 2695 |
| Product Category | Chromatography |
| Operational Age | 2–3 Years |
| Warranty | 6 Months |
| Price Range | USD 8,200 – 11,000 (FOB China Port) |
Overview
The Waters 2695 Separations Module is a modular, high-performance liquid chromatography (HPLC) system originally engineered for robustness, method transfer fidelity, and regulatory compliance in pharmaceutical, environmental, and food safety laboratories. As a core component of the Alliance family, the 2695 integrates a quaternary solvent manager, sample manager, column heater/cooling module, and optional detector interfaces (e.g., UV/Vis, fluorescence, or mass spectrometry couplings). This refurbished unit has undergone full functional validation—including gradient accuracy verification, dwell volume calibration, injection precision testing (RSD < 0.5% at 10 µL), and baseline noise/stability assessment—per ASTM E2647-22 and USP . All critical fluidic paths have been inspected for wear; pump seals, injector rotor seals, and autosampler needle assemblies have been replaced. The system retains its original Waters firmware architecture (Empower 2 or 3 compatible) and supports both isocratic and gradient elution with flow rate stability ±0.1% RSD over 24 h.
Key Features
- Quaternary low-pressure mixing solvent delivery with flow range 0.001–10.000 mL/min and pressure rating up to 5000 psi (345 bar)
- Autosampler with 120-position vial capacity, 0.1–100 µL injection volume range, and temperature-controlled tray (4–40 °C)
- Column compartment with programmable temperature control (5–90 °C), dual-column capability, and real-time pressure monitoring
- Integrated degasser (four-channel helium sparging or vacuum membrane type) ensuring consistent mobile phase composition
- Modular design enabling seamless integration with Waters 2487 UV/Vis detectors, 2475 Multi λ Fluorescence Detectors, or third-party MS systems via analog/digital I/O
- Full Empower 2/3 software compatibility including audit trail, electronic signatures, and 21 CFR Part 11 compliance packages (optional activation)
Sample Compatibility & Compliance
The 2695 accommodates standard 3.9–4.6 mm ID analytical columns (up to 250 mm length) and narrow-bore formats (2.1 mm ID). It supports reversed-phase, normal-phase, ion-exchange, size-exclusion, and hydrophilic interaction liquid chromatography (HILIC) methods. All refurbished units comply with ISO/IEC 17025:2017 calibration traceability requirements through documented instrument qualification (IQ/OQ/PQ) reports. System suitability testing per USP , EP 2.2.46, and JP 6.03 is fully supported. Electrical safety meets UL 61010-1 and IEC 61010-1 standards; CE marking is retained from original manufacturing.
Software & Data Management
The system operates natively with Waters Empower Chromatography Data Software (CDS) versions 2 and 3. Refurbished units ship with validated installation media and license keys for basic acquisition and reporting. Audit trail functionality records all user actions—including method edits, sequence modifications, and result reprocessing—with immutable timestamps. Raw data (.raw files) are stored in vendor-native format and exportable to ASCII, CSV, or AIA/CDF for LIMS integration. Optional GxP modules enable electronic signature enforcement, role-based access control, and automated backup to network-attached storage (NAS) or cloud repositories compliant with HIPAA and GDPR data residency rules.
Applications
This 2695 system is routinely deployed in QC/QA labs for assay validation of active pharmaceutical ingredients (APIs), impurity profiling per ICH Q3B(R2), residual solvent analysis (USP ), and dissolution testing (USP ). Environmental applications include EPA Method 8081B (PCBs), 8270D (semivolatiles), and 548 (pesticides) analysis. Food safety use cases cover mycotoxin quantification (aflatoxins, ochratoxin A), vitamin profiling (B-complex, D3), and adulterant screening (melamine, Sudan dyes). Its proven reproducibility across multi-lab collaborative studies supports GLP and GMP environments requiring long-term method stability.
FAQ
Is this unit eligible for Waters service contracts?
Yes—refurbished 2695 systems retain full eligibility for Waters Care Plans (Basic, Advanced, or Premium tiers) upon registration with Waters Customer Support.
What documentation accompanies the system?
Each unit ships with IQ/OQ/PQ qualification reports, calibration certificates traceable to NIST standards, firmware version logs, and a complete set of operational manuals (English).
Can it be upgraded to support UPLC pressures?
No—the 2695 is an HPLC platform rated to 5000 psi; UPLC-capable operation requires a separate ACQUITY system. However, it fully supports sub-2-µm particle columns at appropriate flow rates and backpressures.
Are spare parts and consumables available?
All OEM parts (pump heads, seal wash kits, injector stators, frits) remain in production and are stocked by global Waters distributors. Third-party consumables meeting ASTM D7219 specifications are also widely available.
Does the warranty cover software updates?
The 6-month hardware warranty excludes software licensing or upgrades; however, Empower patch releases and security updates remain freely accessible via Waters Connect portal during the warranty period.
