Sartorius arium® pro Ultra Pure Water System

Overview

The Sartorius arium® pro Ultra Pure Water System is an engineered solution for the continuous on-demand production of ASTM Type I ultrapure water (18.2 MΩ·cm at 25 °C), meeting stringent requirements for life science research, analytical instrumentation, and regulated pharmaceutical applications. It employs a multi-stage purification architecture grounded in validated physical and chemical separation principles: reverse osmosis (RO) pre-treatment (integrated or external), mixed-bed ion exchange, dual-wavelength ultraviolet photo-oxidation (185 nm for TOC mineralization, 254 nm for microbial inactivation), ultrafiltration (5 kDa cutoff), and terminal sterile filtration using Sartopore® 2 150 polyethersulfone (PES) membranes. This cascaded design ensures consistent removal of ionic contaminants, organic compounds, endotoxins, nucleases, particulates, and viable microorganisms—enabling reproducible water quality essential for HPLC, LC-MS, cell culture, PCR, and trace elemental analysis.

Key Features

• Patented downward-flow purification column design prevents resin stratification, maximizing bed utilization and extending service life.
• Dual-wavelength UV lamp system (185/254 nm) provides simultaneous TOC reduction and microbial control; optional integrated TOC monitor enables real-time verification per USP and EP 2.2.44.
• 5 kDa ultrafiltration module removes endotoxins (<0.001 EU/mL), RNase (<0.004 ng/mL), DNase (<0.024 pg/µL), and other macromolecular impurities critical for molecular biology workflows.
• Sartopore® 2 150 capsule filter features dual-layer 0.45 + 0.2 µm PES membrane certified to HIMA and ASTM F838-22 standards for sterile filtration compliance.
• Full-color touchscreen interface with intuitive menu navigation, multilingual text support, and PIN-protected access control for parameter configuration and alarm thresholds.
• Comprehensive water quality monitoring: real-time resistivity/conductivity at inlet and outlet, temperature-compensated measurements, and visual countdown timers for consumables replacement.
• Flexible dispensing modes: manual (0.1–2.0 L/min via slider), quantitative, and time-based delivery—each logged with timestamp and volume metadata.
• Regulatory-ready data handling: SD card logging (≥1 year of 1-min interval data), RS-232 output for PC integration, and optional thermal printer support for audit trails compliant with FDA 21 CFR Part 11 and GLP/GMP environments.

Sample Compatibility & Compliance

The arium® pro is designed to accommodate variable feed water qualities (e.g., municipal tap, RO permeate, or distilled water) while maintaining output stability across dynamic demand profiles. Its modular architecture supports configuration-specific validation protocols—including IQ/OQ documentation packages aligned with ISO 9001, ISO 13485, and GMP Annex 1. All models meet or exceed ASTM D1193-20 (Type I), CLSI GP30-A4, and ISO 3696:1987 specifications. The arium® pro VF variant—equipped with both UV and UF—is explicitly qualified for applications requiring endotoxin- and nuclease-free water per USP , , and . System materials comply with USP Class VI biocompatibility testing, and wetted components are non-leaching per EP 3.1.1.

Software & Data Management

The embedded firmware supports full lifecycle data capture without third-party software dependency. Each dispense event records volume, time, resistivity, TOC (if equipped), temperature, and user ID (where PIN-authenticated). Data export formats include CSV and PDF reports compatible with LIMS integration. Audit trail functionality satisfies ALCOA+ principles: attributable, legible, contemporaneous, original, and accurate—with immutable timestamps and change logs for all configuration modifications. Optional Ethernet connectivity (via external adapter) enables remote status monitoring and centralized fleet management in multi-lab facilities.

Applications

• HPLC, UHPLC, and LC-MS mobile phase preparation where low TOC and ionic background prevent column fouling and signal drift.
• Cell culture media formulation and passaging, where endotoxin and nuclease contamination compromise viability and experimental reproducibility.
• Molecular assays including RT-qPCR, NGS library prep, and CRISPR editing—requiring DNase/RNase-free water to preserve nucleic acid integrity.
• Atomic absorption spectroscopy (AAS), inductively coupled plasma (ICP-OES/MS), and ion chromatography (IC), where sub-ppt metal contamination must be excluded.
• Pharmaceutical QC testing under USP and EP 2.2.44, supporting validation of water for injection (WFI)-adjacent processes.
• Electrophoresis buffer preparation and glassware rinsing for trace-level elemental analysis.

FAQ

What feed water quality is required for optimal performance?
The arium® pro is designed for use with pretreated water (e.g., RO permeate or deionized water). Feed conductivity should remain below 50 µS/cm; higher levels require optional pre-filtration upgrades.
Can the system be validated for GMP compliance?
Yes—Sartorius provides IQ/OQ documentation templates, calibration certificates for sensors, and material traceability records suitable for regulatory submissions.
How often must consumables be replaced?
Replacement intervals depend on feed water quality and daily usage volume; the system calculates remaining service life in real time and triggers visual/audible alerts when thresholds are reached.
Is remote monitoring supported natively?
Native Ethernet is not included but can be added via approved external adapters; RS-232 and SD card logging provide primary data export paths.
Does the arium® pro meet USP requirements for purified water?
While optimized for ultrapure output, its base configuration (arium® pro DI) meets USP specifications for Purified Water when fed with appropriate pretreated source water.