Waters 2695 Separations Module HPLC System
| Brand | Waters |
|---|---|
| Origin | USA |
| Model | 2695 |
| Instrument Type | Conventional High-Performance Liquid Chromatograph |
| Application Scope | General-purpose analytical HPLC |
Overview
The Waters 2695 Separations Module is a modular, high-reliability high-performance liquid chromatography (HPLC) system originally engineered by Waters Corporation in the United States. Designed for robust routine analysis in regulated and research environments, the 2695 platform operates on classical isocratic and gradient elution principles using dual-piston reciprocating pumps, precision solvent proportioning valves, and temperature-stabilized column compartments. Its architecture supports integration with UV/Vis detectors (e.g., Waters 2487, 2489), fluorescence detectors, or mass spectrometers via analog/digital interfaces. As a pre-2010 generation system, it complies with foundational chromatographic performance standards including USP , ASTM D5845 (for hydrocarbon analysis), and ISO 17025–aligned laboratory practices when maintained per manufacturer specifications.
Key Features
- Modular design enabling flexible configuration: separations module, sample manager, column heater, and detector interface operate independently yet synchronously
- Dual-plunger, high-pressure reciprocating pump with flow accuracy ±0.2% RSD and pressure stability up to 5000 psi (34.5 MPa)
- Autosampler with 120-position vial capacity, injection volume range 0.1–100 µL, and programmable needle wash cycles
- Column compartment with Peltier-based temperature control (5–60 °C), ±0.5 °C stability
- Integrated system controller with built-in Ethernet port and RS-232/485 serial communication for legacy instrument interfacing
- Full compatibility with Waters Millennium32 and Empower™ 1/2 software suites for method development, data acquisition, and audit-trail-enabled reporting
Sample Compatibility & Compliance
The 2695 system accommodates standard 3.9–4.6 mm ID analytical columns (up to 250 mm length) and is routinely deployed for small-molecule quantification in pharmaceutical QC, environmental contaminant screening (e.g., PAHs, pesticides), food additive profiling, and natural product fractionation. It meets baseline requirements for GLP-compliant laboratories when operated with validated methods and documented maintenance records. While not natively compliant with FDA 21 CFR Part 11 out-of-the-box, full electronic signature and audit trail functionality can be achieved through Empower™ 2 with appropriate server configuration and administrative controls. All hardware components conform to IEC 61010-1 safety standards for laboratory electrical equipment.
Software & Data Management
Data acquisition and processing are executed via Waters’ proprietary software platforms—primarily Millennium32 (for legacy method migration) and Empower™ 1 or 2 (for regulated environments). Empower™ provides secure user roles, electronic signatures, method versioning, raw data archiving, and automated report generation. Raw chromatograms are stored in .raw format; processed results export to CSV, PDF, or XML for LIMS integration. System suitability testing (SST) templates—including resolution, tailing factor, and %RSD calculations—are embedded per USP and EP guidelines. Audit trails record all parameter changes, injections, and report modifications with timestamps and operator IDs.
Applications
- Pharmaceutical quality control: assay of active pharmaceutical ingredients (APIs), related substances, and dissolution testing per USP monographs
- Environmental analysis: quantification of nitrate, phosphate, and organic pollutants in wastewater per EPA Method 8081B and ISO 10304-1
- Food and beverage testing: detection of preservatives (e.g., benzoic acid, sorbic acid), sweeteners, and mycotoxins in compliance with EU Regulation (EC) No 1881/2006
- Academic and industrial research: method development for chiral separations, polymer characterization, and natural extract profiling
- Method transfer support: stable retention time reproducibility (<0.2% RSD over 24 h) enables reliable inter-laboratory validation
FAQ
Is the Waters 2695 compatible with modern data systems such as LIMS or CDS?
Yes—when paired with Empower™ 2 or later, the system supports ODBC-compliant database connections and HL7/SOAP-based API integrations for bidirectional LIMS communication.
What maintenance documentation is provided with a refurbished unit?
Each unit undergoes full functional verification, pump seal replacement, detector lamp calibration, and leak testing. A comprehensive service report—including pressure profiles, baseline noise measurements, and SST results—is delivered with shipment.
Can the 2695 run UHPLC columns?
No—it is rated for maximum operating pressure of 5000 psi and lacks low-dead-volume fluidics required for sub-2 µm particle columns; use is limited to conventional HPLC columns (≥3 µm particles).
Does this system support gradient delay compensation?
Yes—the 2695’s built-in gradient dwell volume calculator allows manual input of system dwell volume (typically 1.2–1.8 mL) for precise retention time alignment across methods.
Is remote monitoring supported?
Via Empower™ Web Access or third-party OPC-UA gateways, real-time status (pressure, flow, temperature, run progress) can be viewed on enterprise networks with proper firewall configuration.
