Millipore Elix 35 Laboratory Pure Water System

Overview

The Millipore Elix 35 is a robust, modular laboratory pure water system engineered for continuous production of Type II analytical-grade water in compliance with ASTM D1193-20, ISO 3696:1995, CLSI EP21-A, and pharmacopoeial standards including USP , Ph. Eur. 2.2.44, and JP 2.07. Utilizing a multi-stage purification architecture—comprising pretreatment (activated carbon + dual-grade sediment filtration), reverse osmosis (RO), and continuous electrodeionization (CEDI) via patented Elix technology—the system delivers stable, low-conductivity water without chemical regeneration or downtime. Unlike batch-mode deionization systems, the Elix CEDI module enables real-time ion exchange resin regeneration through applied DC current, ensuring consistent resistivity (>5 MΩ·cm at 25°C) and minimizing operational variability across fluctuating feed water quality. Designed for integration into centralized distribution networks, the Elix 35 serves as both a standalone point-of-use unit and a primary feed source for downstream ultra-pure water systems such as Milli-Q® or Super-Q® platforms.

Key Features

• Patented Elix continuous electrodeionization (CEDI) technology ensures uninterrupted resin regeneration and stable water quality without manual intervention or chemical regeneration cycles.
• Integrated real-time monitoring: built-in temperature-compensated resistivity sensor (0.01–18.2 MΩ·cm range) and TOC analyzer (<30 ppb detection limit) provide continuous, auditable water quality verification.
• UV lamp (185/254 nm) integrated into the polishing loop suppresses microbial proliferation and photo-oxidizes trace organics—critical for cell culture media preparation and molecular biology applications.
• Pretreatment flexibility: modular, field-replaceable prefilter cartridges (carbon + sediment) allow customization based on local feed water hardness, chlorine content, and particulate load—eliminating the need for external softeners in most municipal supplies.
• Full-system control architecture: touchscreen HMI enables configuration and logging of all operational parameters—including flow rate, pressure differentials, RO rejection ratio, CEDI voltage/current, and alarm thresholds—with configurable user access levels.
• Centralized distribution readiness: supports connection to recirculating loops via optional pump modules, ASM (air-gap sanitary manifold), and distributed sensors (remote resistivity/TOC nodes), enabling GMP-aligned water system validation per FDA 21 CFR Part 11 requirements.

Sample Compatibility & Compliance

The Elix 35 is validated for use with standard municipal tap water (feed conductivity ≤500 µS/cm, [CO₂] <30 ppm, free chlorine ≤2 ppm). It meets or exceeds purity specifications required for ISO/IEC 17025-accredited laboratories and complies with GLP and GMP environmental monitoring protocols. All electronic logs—including sensor outputs, maintenance events, and parameter changes—are time-stamped, user-identified, and exportable in CSV format for audit readiness. The system’s firmware supports electronic signature capability and audit trail functionality aligned with FDA 21 CFR Part 11 Annex 11 and EU GMP Annex 11 requirements when deployed in regulated pharmaceutical QC environments.

Software & Data Management

Equipped with Millipore’s Elix Control Software v3.x, the system provides secure remote monitoring via Ethernet or optional Wi-Fi interface. Data logging intervals are configurable from 1 second to 24 hours; historical records are retained for ≥12 months onboard and can be exported via USB or network share. Alarm management includes tiered notifications (visual, audible, email/SMS via SMTP integration) for critical deviations—e.g., TOC excursion >30 ppb, resistivity drop below 4.5 MΩ·cm, or UV lamp failure. All calibration events, consumable replacements, and service interventions are automatically timestamped and linked to operator ID, supporting full traceability during regulatory inspections.

Applications

• Preparation of microbiological growth media, PBS, Tris-HCl buffers, and electrophoresis solutions requiring low ionic background and minimal organic contamination.
• Feed water for Milli-Q® IQ7000, Milli-Q® Integral, or Super-Q® ultra-pure water systems—ensuring optimal lifetime of final polishing cartridges and ultraviolet oxidation units.
• Pharmaceutical manufacturing support: compliant with USP Purified Water monograph for non-sterile formulation processes and equipment rinsing.
• Automated analyzers (e.g., ICP-MS, HPLC, GC-MS) where dissolved ions or organics may cause baseline drift or column fouling.
• Hydroponic research and plant tissue culture, where silicate-free water prevents precipitate formation in nutrient solutions.
• Calibration standards preparation and reference material dilution in metrology labs accredited to ISO/IEC 17025.

FAQ

What feed water quality is required for optimal Elix 35 performance?
Municipal tap water with total dissolved solids (TDS) ≤500 ppm, free chlorine ≤2 ppm, and turbidity <1 NTU is suitable. Pre-treatment cartridge life is extended when feed water hardness is <10°dH; no external softener is needed under these conditions.
Can the Elix 35 be validated for GMP environments?
Yes—the system supports IQ/OQ documentation packages, electronic audit trails, user access control, and 21 CFR Part 11-compliant data integrity features when configured with optional software modules and qualified peripherals.
How often must consumables be replaced?
Pretreatment cartridges require replacement every 6–12 months depending on feed water quality; the Elix CEDI module has a typical service life of 3–5 years under continuous operation and does not require periodic chemical regeneration.
Is remote monitoring supported out of the box?
Ethernet connectivity is standard; remote access requires configuration of the embedded web server and network firewall rules. Optional Wi-Fi dongle and cloud-based dashboard subscription are available for enterprise fleet management.
Does the system include TOC monitoring as standard?
Yes—integrated TOC analyzer with UV/persulfate oxidation and NDIR detection is included in all Elix 35 configurations, delivering real-time measurements with <30 ppb sensitivity and automatic zero/sensitivity verification.