ELGA PURELAB Classic Ultra Pure Water System

Overview

The ELGA PURELAB Classic Ultra Pure Water System is a modular, microprocessor-controlled laboratory water purification platform engineered for consistent production of ASTM Type I (ISO Grade 1) ultrapure water. Designed around core purification technologies—including deionization (DI), dual-wavelength ultraviolet oxidation (UV), and ultrafiltration (UF)—the Classic series delivers water meeting stringent analytical and life science application requirements. Each system employs a multi-stage purification architecture: pretreatment (typically reverse osmosis), primary ion removal via mixed-bed or electrodeionization modules, advanced organic oxidation using 185/254 nm UV lamps, and final endotoxin/particulate polishing via low-protein-binding ultrafiltration membranes. The system operates under continuous resistivity monitoring at 25 °C and integrates real-time TOC detection in UV-equipped models. Its closed-loop hydraulics and non-leaching wetted materials (e.g., PVDF, PTFE, and sanitary-grade stainless steel) minimize recontamination risk and ensure long-term stability of 18.2 MΩ·cm resistivity and sub-ppb TOC performance.

Key Features

• Modular configuration: Four standardized variants—Classic DI, Classic UV, Classic UF, and Classic UVF—allow precise alignment with application-specific purity demands (e.g., HPLC mobile phase prep, cell culture media formulation, or molecular biology workflows).
• GLP-compliant data tracking: Embedded memory logs cartridge history—including resin batch number, fill date, cumulative usage time, and regeneration cycles—with tamper-resistant timestamps; accessible via front-panel display or exportable for audit readiness.
• Preventive operational safeguards: Intelligent cartridge recognition prevents misinstallation or cross-use of incompatible modules; system halts operation if incorrect module placement is detected.
• Variable flow control: Precision-adjustable dispensing from dropwise delivery (for sensitive assays) up to 2 L/min (for bulk preparation), programmable with user-defined PIN authentication.
• Full-wet-path sanitization: Automated thermal or chemical disinfection cycle cleans all fluid-contact surfaces—including storage reservoirs, distribution loops, and final filters—reducing biofilm formation and extending consumable service life.
• Real-time water quality monitoring: Continuous resistivity measurement with temperature compensation; optional integrated TOC sensor with UV-persulfate oxidation and NDIR detection (in UV and UVF models).

Sample Compatibility & Compliance

The PURELAB Classic is validated for compatibility with high-sensitivity analytical instrumentation—including LC-MS, ICP-MS, and atomic absorption spectrometry—as well as cell-based assays requiring low endotoxin and particulate burden. All models comply with ASTM D1193-23 (Type I specifications), ISO 3696:1987 (Grade 1), and CLSI EP21-A guidelines for water used in clinical and research laboratories. UVF and UF variants meet USP requirements for Water for Injection (WFI)-adjacent applications due to endotoxin removal (0.1 µm. Systems support 21 CFR Part 11-compliant electronic records when paired with ELGA’s optional DataTrace software, enabling secure user access control, electronic signatures, and immutable audit trails for GMP/GLP-regulated environments.

Software & Data Management

The onboard single-board controller provides intuitive menu navigation and real-time status visualization—including cartridge remaining life, conductivity/TOC trends, and sanitization cycle logs. No external PC is required for routine operation; however, optional DataTrace software enables centralized fleet management across multiple PURELAB units, remote diagnostics, and automated report generation aligned with ISO/IEC 17025 documentation standards. All stored data adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and may be exported in CSV or PDF formats for internal QA review or regulatory submissions.

Applications

• HPLC, UHPLC, and LC-MS mobile phase and blank preparation
• ICP-OES and ICP-MS sample dilution and standard preparation
• Cell culture media and reagent formulation requiring low endotoxin and nuclease-free water
• PCR, qRT-PCR, and next-generation sequencing (NGS) assay setup
• Electrophysiology and patch-clamp solutions demanding ultra-low ionic background
• Calibration standard preparation for trace metal analysis
• Pharmaceutical QC testing per USP and EP 2.2.44

FAQ

What distinguishes the Classic UVF model from the Classic UV?
The UVF integrates a final ultrafiltration membrane that removes endotoxins, nucleases, and particles >0.1 µm—making it suitable for sterile-sensitive applications such as mammalian cell culture and molecular diagnostics.
Can the system be connected to a central purified water loop?
Yes—Classic systems support integration into recirculating distribution networks via optional pressure-regulated feed kits and loop-compatible pump modules.
How often must the ultrafiltration cartridge be replaced?
Under typical lab usage (≤100 L/day), the UF cartridge maintains performance for 6–12 months; replacement intervals are tracked automatically and displayed on the control panel.
Is validation documentation provided with the system?
Each unit ships with a Factory Acceptance Test (FAT) report, IQ/OQ templates aligned with ISO 13485 and GAMP 5, and a Certificate of Conformance to ASTM D1193-23 and ISO 3696:1987.
Does the Classic series support remote monitoring via Ethernet or Wi-Fi?
Ethernet connectivity is available via optional DataTrace interface module; Wi-Fi is not supported due to cybersecurity constraints in regulated laboratory networks.