ELGA PURELAB Classic Ultra Pure Water System

Overview

The ELGA PURELAB Classic is a benchtop ultra-pure water system engineered for laboratories requiring consistent, high-fidelity Type I water per ISO 3696 and ASTM D1193 Grade I specifications—without compromising operational simplicity or long-term cost efficiency. It employs a multi-stage purification architecture integrating deionization (DI), dual-wavelength ultraviolet oxidation (185/254 nm), and ultrafiltration (UF) to remove ions, organic contaminants, microorganisms, nucleases, and endotoxins. Unlike modular or high-throughput systems, the PURELAB Classic prioritizes reliability and ease-of-use in mid-volume research and QC environments where daily demand ranges from 20 to 100 liters. Its design adheres to core principles of water purity assurance: closed-loop recirculation with continuous UV exposure, low-dead-volume distribution paths, and non-leaching wetted materials (e.g., PTFE, PVDF, and pharmaceutical-grade stainless steel). The system delivers water meeting stringent requirements for sensitive analytical techniques—including those governed by USP , CLSI EP22-A, and ISO 15195—while maintaining full traceability under GLP and GMP-aligned operational protocols.

Key Features

• Stable resistivity output of 18.2 MΩ·cm at 25 °C, continuously monitored via integrated high-accuracy conductivity sensor with automatic temperature compensation.
• Low TOC performance: 1–3 ppb typical, achieved through 185 nm UV photo-oxidation followed by ion exchange and 254 nm UV germicidal treatment.
• Endotoxin-free water (<0.001 EU/mL) enabled by optional LC197 pyrogen-removing ultrafilter, certified to meet USP and EP 2.6.14 standards.
• Front-access service design: All consumables—including DI cartridges, UV lamps, and UF modules—are replaced without tools or system disassembly.
• Intuitive single-knob interface with real-time display of resistivity, TOC, flow rate, and cartridge life indicators—no software installation required for basic operation.
• Integrated air-gap dispensing valve prevents back-contamination; compatible with wall-mounted or countertop point-of-use (POU) outlets.

Sample Compatibility & Compliance

The PURELAB Classic produces water suitable for preparation of critical reagents, calibration standards, and mobile phases used in HPLC, IC, GC-MS, ICP-MS, and electrophoresis applications. Its microbial and nuclease specifications support molecular biology workflows including PCR setup, cell culture media preparation, and RNA/DNA extraction. The system complies with ISO 3696:1987 (Grade 1), ASTM D1193-20 (Type I), and CLSI EP22-A (for water used in clinical laboratory testing). When equipped with the LC197 filter and operated per ELGA’s validated maintenance schedule, it satisfies FDA 21 CFR Part 11 data integrity expectations for audit trails when paired with optional logging accessories. All wetted components are USP Class VI compliant and extractables-tested per ICH Q5C guidelines.

Software & Data Management

While the base PURELAB Classic operates without embedded software, optional connectivity modules enable integration with ELGA’s AquaLogic™ remote monitoring platform. This provides secure, encrypted access to historical water quality logs (resistivity, TOC, UV intensity, flow volume), predictive cartridge replacement alerts, and electronic maintenance records—all exportable in CSV or PDF for internal QA review. Audit trail functionality meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) and supports 21 CFR Part 11 compliance when deployed with user authentication and electronic signature capability. No local database installation is required; data resides on validated cloud infrastructure hosted within EU-based data centers.

Applications

• HPLC and UHPLC mobile phase preparation and instrument rinsing
• ICP-MS sample dilution and blank matrix generation
• TOC analyzer calibration and system suitability testing
• Atomic absorption spectroscopy (AAS) standard dilution and flame/gas introduction
• Electrophoresis buffer preparation and gel casting
• Cell culture media formulation and sterile filtration support
• Clinical diagnostics assay development per CLIA and CAP requirements

FAQ

What is the maximum recommended daily usage volume for sustained 18.2 MΩ·cm output?
For optimal performance and cartridge longevity, ELGA recommends average daily consumption below 80 liters. Higher intermittent demands may be accommodated, but extended >100 L/day operation requires evaluation of feed water quality and DI resin capacity.
Can the PURELAB Classic supply water directly to an HPLC autosampler?
Yes—when connected via a dedicated POU outlet with integrated 0.22 µm sterilizing-grade filter, the system meets ASTM D1193 Type I requirements for HPLC-grade water delivery. Tubing must be non-reactive (e.g., PTFE or fluorinated ethylene propylene) and installed with minimal dead legs.
Is validation documentation available for IQ/OQ/PQ protocols?
ELGA provides comprehensive qualification templates, including test scripts, acceptance criteria, and blank record forms aligned with ISO/IEC 17025 and Annex 15. Site-specific OQ execution requires third-party verification of feed water parameters and environmental conditions.
How often must the UV lamp be replaced?
The 185/254 nm dual-band UV lamp is rated for 12 months of continuous operation or 9,000 hours—whichever occurs first—and is automatically flagged via the front-panel indicator upon reaching end-of-life.
Does the system support remote diagnostics?
With the AquaLogic™ Connect module installed, authorized service engineers can perform secure remote health checks—including pressure drop analysis across filters, UV intensity decay profiling, and historical alarm review—subject to customer network policy approval.