ELGA PURELAB Classic Series Ultra-Pure Water System
| Brand | ELGA |
|---|---|
| Origin | United Kingdom |
| Model | DI/UV/UF/UVF |
| Resistivity | 18.2 MΩ·cm @ 25 °C |
| Heavy Metals & Soluble Silica | <0.1 ppb |
| Total Organic Carbon (TOC) | 1–3 ppb |
| Microbial Count | <0.1 CFU/mL |
| Endotoxins | <0.001 EU/mL |
| Particles (>0.1 µm) | <0.2 particles/mL |
| DNase | <0.02 pg/mL |
| RNase | <0.002 ng/mL |
Overview
The ELGA PURELAB Classic Series is a benchtop ultra-pure water system engineered for laboratories requiring consistent, high-fidelity Type I water (ASTM D1193-20, ISO 3696:1987, CLSI EP22-A2) under cost-conscious operational constraints. It employs a multi-stage purification architecture—comprising deionization (DI), dual-wavelength ultraviolet oxidation (UV at 185 nm and 254 nm), ultrafiltration (UF), and optional final UV filtration (UVF)—to achieve and sustain resistivity of 18.2 MΩ·cm at 25 °C, with TOC consistently maintained between 1–3 ppb. The system operates on a closed-loop recirculation principle with continuous UV irradiation and membrane-based endotoxin removal, ensuring microbiological integrity and molecular purity essential for sensitive analytical and life science applications.
Key Features
- Stable 18.2 MΩ·cm resistivity output, continuously monitored via in-line high-accuracy conductivity sensor calibrated to NIST-traceable standards
- Integrated dual-wavelength UV lamps (185 nm for advanced TOC oxidation; 254 nm for microbial inactivation) with real-time lamp intensity monitoring and automatic replacement alerts
- Final-stage ultrafiltration (UF) cartridge incorporating low-protein-binding regenerated cellulose membrane (nominal pore size: 10 kDa MWCO), validated for endotoxin removal (<0.001 EU/mL) and nuclease depletion (DNase <0.02 pg/mL; RNase <0.002 ng/mL)
- Front-access service design enabling tool-free, single-handed replacement of all consumables—including DI cartridges, UV sleeves, and UF modules—minimizing downtime and supporting GLP-compliant maintenance logging
- Programmable flow rate up to 2.0 L/min at point-of-use, with adjustable dispensing modes (volume, time, continuous) and ergonomic wall- or bench-mounted dispensing arm options
- Compliance-ready architecture: supports audit trails, user access levels, and electronic logbooks compatible with FDA 21 CFR Part 11 requirements when integrated with ELGA’s optional DataTrace software suite
Sample Compatibility & Compliance
The PURELAB Classic Series delivers water meeting or exceeding the strictest international specifications for Type I reagent water: ASTM D1193-20 (Grade I), ISO 3696:1987 (Grade 1), CLSI EP22-A2 (for molecular diagnostics), and USP Purified Water and Water for Injection (WFI) support protocols when paired with appropriate terminal filtration. Its low endotoxin and nuclease content make it suitable for cell culture media preparation, qPCR master mix formulation, and monoclonal antibody purification workflows. All wetted materials comply with USP Class VI biocompatibility standards; system validation documentation (DQ/IQ/OQ) is available per GMP Annex 15 guidelines.
Software & Data Management
While the base PURELAB Classic operates via intuitive tactile controls and an LCD status display, optional connectivity modules enable integration into centralized lab infrastructure. The ELGA DataTrace software provides secure, encrypted data capture—including resistivity, TOC, UV transmittance, filter lifetime, and dispense event logs—with configurable alarm thresholds and automated report generation (PDF/CSV). All electronic records include date/time stamps, operator ID, and immutable audit trails compliant with GLP and GMP data integrity principles (ALCOA+ framework). Remote diagnostics and predictive maintenance alerts are supported via ELGA’s cloud-enabled ServiceLink platform (subscription required).
Applications
- HPLC and UHPLC mobile phase preparation and column equilibration
- ICP-MS and ICP-OES sample dilution and blank matrix generation
- Atomic absorption spectroscopy (AAS) standard calibration and rinse solutions
- Electrophoresis buffer preparation and gel casting
- TOC analyzer calibration and system suitability testing
- Cell culture media, transfection reagents, and CRISPR-Cas9 reaction buffers
- Cleaning of precision optical components and semiconductor-grade glassware
FAQ
What is the recommended maintenance schedule for the PURELAB Classic system?
Routine maintenance includes quarterly verification of resistivity and TOC performance, biannual replacement of UV lamps (with intensity decay tracking), and consumable replacement based on system-generated usage metrics—typically every 6–12 months depending on feed water quality and daily throughput.
Can the system be validated for GMP-regulated environments?
Yes. ELGA provides full qualification documentation packages (DQ/IQ/OQ/PQ), IQ/OQ execution support, and customizable validation protocols aligned with EU GMP Annex 15 and FDA guidance on computerized systems.
Is the output water suitable for LC-MS applications?
The UVF configuration (with final 254 nm UV + UF) delivers water with sub-ppb TOC and undetectable phosphatase activity—validated for electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) source compatibility in routine LC-MS workflows.
How does the system handle variable inlet water quality?
Integrated pre-treatment monitoring (feed conductivity, hardness, chlorine) triggers adaptive regeneration cycles in the DI stage and adjusts UV exposure duration to maintain consistent outlet specifications—even with municipal tap water inputs meeting ASTM D1193 Type IV standards.
What certifications apply to the wetted components?
All fluid path materials—including tubing, seals, membranes, and housings—are certified to USP Class VI, FDA 21 CFR 177, and EC 1935/2004 food-contact compliance, with full material traceability documentation available upon request.
