Thermo Scientific Nanopure Ultra Pure Water Purification System

Overview

The Thermo Scientific Nanopure Ultra Pure Water Purification System is an engineered solution for laboratories requiring continuous, on-demand production of Type I ultrapure water compliant with stringent analytical, pharmaceutical, and life science applications. Based on a multi-stage purification architecture—including reverse osmosis pre-treatment, dual-wavelength UV oxidation (185/254 nm), ion exchange, ultrafiltration, and final 0.2 µm membrane filtration—the Nanopure system delivers water with resistivity exceeding 18.2 MΩ·cm at 25 °C, TOC consistently below 5 ppb, and endotoxin levels under 0.001 EU/mL. Its design reflects over 125 years of Thermo Fisher Scientific’s expertise in laboratory water systems, integrating robust fluidic pathways, low-dead-volume distribution manifolds, and non-leaching wetted materials (e.g., PFA, PVDF, and high-purity quartz) to prevent recontamination. Unlike modular benchtop systems, the Nanopure platform is purpose-built for reproducibility across variable feedwater conditions—whether municipal tap, distilled, or RO source—and maintains stable output quality even during extended operation cycles.

Key Features

• Integrated real-time TOC monitoring with dual-wavelength UV detection, enabling continuous verification of organic removal efficiency without manual sampling.
• Four-in-one high-capacity purification cartridge assembly—configurable based on inlet water quality (e.g., high-silica, high-chloride, or high-hardness feed)—reducing service frequency and total cost of ownership.
• Precision dispensing functionality with volumetric accuracy of ±5% and repeatability of ±3% across a range from 0.25 L to 60 L per dispense, supporting automated workflows in cell culture, HPLC mobile phase preparation, and ICP-MS calibration.
• Detachable touchscreen control panel with password-protected user access levels, supporting remote operation via wall-mounted or under-bench mounting options—ideal for cleanroom integration or space-constrained environments.
• Self-diagnostic firmware with predictive maintenance alerts, automatic system sanitization cycles, and audible/visual fault notifications for pressure drop, UV lamp degradation, or cartridge exhaustion.
• NIST-traceable conductivity calibration module included as standard—eliminating reliance on third-party calibration services while ensuring compliance with ISO/IEC 17025 internal audit requirements.

Sample Compatibility & Compliance

The Nanopure system produces water meeting or exceeding the specifications defined in ASTM D1193 Type I, CLSI (formerly NCCLS) EP21-A, and College of American Pathologists (CAP) water quality standards for clinical and research laboratories. Its endotoxin and particle specifications (<0.001 EU/mL and 0.2 µm particles) support applications in monoclonal antibody formulation, stem cell expansion, and pyrogen-sensitive assays. All wetted components comply with USP Class VI biocompatibility testing, and the system architecture supports GLP/GMP-aligned operational documentation when paired with optional audit trail-enabled software. Electrical safety conforms to CSA C22.2 No. 61010-1 and CE marking per Directive 2014/30/EU (EMC) and 2014/35/EU (LVD).

Software & Data Management

Equipped with an RS-232 serial interface as standard, the Nanopure system enables direct connection to laboratory information management systems (LIMS), networked printers, or dedicated data acquisition workstations. Timestamped water quality logs—including resistivity, TOC, UV absorbance, flow volume, and cartridge life metrics—are exportable in CSV format for traceability. When deployed in regulated environments, the system supports 21 CFR Part 11-compliant electronic records when integrated with Thermo Fisher’s optional H2O SELECT Analytics Suite, which provides role-based user authentication, electronic signatures, and immutable audit trails for all system events and calibration actions.

Applications

• HPLC, UHPLC, and LC-MS mobile phase and blank preparation where low TOC and silica are critical to column longevity and baseline stability.
• Cell and tissue culture media preparation requiring endotoxin-free water to prevent cytokine induction and false phenotypic responses.
• Atomic absorption spectroscopy (AAS), inductively coupled plasma mass spectrometry (ICP-MS), and graphite furnace AAS, where sub-ppt metal contamination must be excluded.
• Molecular biology workflows including PCR, qRT-PCR, and next-generation sequencing library prep, where DNase/RNase-free water is essential.
• Pharmaceutical QC testing per USP “Water for Pharmaceutical Purposes” and EP 2.2.44 “Water for Injection (WFI) – Purified Water” specifications.

FAQ

Does the Nanopure system require external pretreatment for municipal feed water?
Yes—while the system includes integrated RO and dual-wavelength UV, optimal performance and cartridge lifetime depend on feed water meeting minimum pretreatment criteria (e.g., <5 ppm chlorine, <1 ppm iron, <10 ppm hardness). Thermo Fisher’s free H2O SELECT assessment evaluates site-specific feedwater and recommends appropriate upstream conditioning.
Can the Nanopure system be validated for GMP use?
Yes—the platform supports IQ/OQ/PQ documentation packages, and its firmware and hardware architecture align with Annex 15 and FDA guidance on computerized system validation. Optional IQ/OQ kits and 21 CFR Part 11-compliant software modules are available.
Is real-time TOC monitoring calibrated automatically?
No—TOC sensor calibration requires periodic verification using certified standard solutions; however, the system logs calibration history and prompts users at configurable intervals per internal SOPs.
What is the expected service interval for the four-in-one purification cartridge?
Cartridge life varies by feedwater quality and daily usage volume; typical replacement intervals range from 6 to 12 months under standard lab conditions (≤100 L/day, municipal feed with ≤200 ppm TDS). The system calculates remaining capacity based on actual flow and resistivity decay trends.
Does the Nanopure system support Ethernet or Wi-Fi connectivity?
No—only RS-232 is provided as standard. For network integration, a serial-to-Ethernet converter or Thermo Fisher’s optional H2O CONNECT gateway (sold separately) is required to enable TCP/IP communication and cloud-based monitoring.