RephiLe Genie PURIST Ultra-Pure Water System
| Brand | RephiLe |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Regional Category | Domestic (China) |
| Model | Genie PURIST |
| Price Range | USD 14,000 – 42,000 (FOB Shanghai) |
| Feed Water | EDI-purified, RO, or distilled water |
| Resistivity | >18.2 MΩ·cm @ 25 °C |
| Heavy Metals & Soluble Silica | <0.01 ppb |
| Total Organic Carbon (TOC) | <2 ppb (typical <5 ppb under standard operation) |
| Microbial Count | <0.001 CFU/mL |
| Endotoxin | <0.001 EU/mL (with optional RephiBio terminal filter) |
| Particles (>0.2 µm) | Zero particles ≥0.22 µm (with 0.2 µm terminal filter) |
Overview
The RephiLe Genie PURIST Ultra-Pure Water System is an intelligent, modular laboratory water purification platform engineered for the consistent production of Type I ultrapure water per ISO 3696:1987, ASTM D1193-20, CLSI EP22-A, and GB/T 6682–2008 Grade 1 specifications. Unlike conventional single-point systems, Genie PURIST employs a multi-stage purification architecture integrating reverse osmosis (RO) pre-treatment compatibility, dual-wavelength UV photooxidation (172 nm + 254 nm), electro-deionization (EDI)-ready feed input, and customizable ultrafiltration modules. Its core measurement principle relies on real-time conductivity-to-resistivity conversion (temperature-compensated to 25 °C), coupled with continuous online TOC monitoring via high-sensitivity catalytic oxidation and NDIR detection. Designed for integration into regulated environments, the system supports audit-ready data integrity through time-stamped, non-modifiable water quality logs compliant with ALCOA+ principles.
Key Features
- 1+N Wireless Distribution Architecture: One central purification unit supports up to 10 independently addressable wireless dispensing handles—eliminating cable constraints and enabling flexible lab layout optimization.
- Multi-Sensor Integration Hub: Optional analog/digital inputs accept third-party probes (pH, dissolved oxygen, turbidity, conductivity) for synchronized parameter logging and unified reporting on the main HMI screen.
- High-Fidelity Touch Interface: IP65-rated capacitive touchscreen operates reliably with wet hands or nitrile/latex gloves; no stylus required.
- Configurable Purification Pathways: Interchangeable ultra-purification cartridges—including low-magnesium, low-boron, low-organic, ICP-grade, and DI-specific media—allow precise tailoring for HPLC mobile phase preparation, cell culture media formulation, or trace-metal analysis.
- RephiBio Terminal Filtration: Certified 0.2 µm hydrophilic polyethersulfone membrane with integrated endotoxin-removal layer ensures <0.001 EU/mL endotoxin, <0.5 pg/mL RNase, and <10 pg/mL DNase levels—validated per USP and .
- Intelligent Component Management: All consumables (RO membranes, UV lamps, UF filters, purification columns) embed NFC-enabled chips for automatic recognition, usage tracking, and predictive replacement alerts.
- Fail-Safe Protection Suite: Includes leak detection with automatic shutdown, dry-run pump protection, real-time inlet conductivity monitoring, and non-invasive liquid level sensing compatible with stainless steel, polyethylene, and glass reservoirs.
Sample Compatibility & Compliance
Genie PURIST delivers ultrapure water suitable for critical applications requiring stringent chemical and biological purity: HPLC, LC-MS, ICP-MS, and AAS mobile phase and rinse solutions; mammalian cell culture media and buffer preparation; molecular biology workflows including PCR, qRT-PCR, and CRISPR reagent synthesis; and nanomaterial dispersion stability studies. The system meets ISO 13485 design control requirements and carries CE marking per Directive 2014/30/EU (EMC) and 2011/65/EU (RoHS). All firmware and data management functions comply with FDA 21 CFR Part 11 Annex 11 expectations for electronic records and signatures when deployed in GxP environments. Full traceability is maintained via encrypted, timestamped audit trails for every dispense event, sensor reading, and maintenance action.
Software & Data Management
The embedded Linux-based operating system logs all water quality parameters—including resistivity, TOC, temperature, flow rate, and pressure—at user-defined intervals (1 sec to 60 min). Data exports as CSV or PDF files with digital signature verification and SHA-256 hash integrity checks. Optional cloud connectivity enables remote system health monitoring and centralized fleet management across multi-site laboratories. Calibration logs, consumable lifecycle history, and service technician sign-offs are stored in immutable format for GLP/GMP audits. No proprietary software installation is required: web-based configuration and diagnostics accessible via standard HTTPS browser interface.
Applications
- HPLC, IC, and LC-MS mobile phase preparation and column equilibration
- ICP-MS and GF-AAS trace metal analysis where boron, sodium, or potassium contamination must be minimized
- Cell culture media, PBS, and trypsin solution preparation per ATCC and EMA guidelines
- Molecular biology applications including plasmid isolation, RNA sequencing library prep, and synthetic biology vector construction
- Calibration standard and blank solution preparation for environmental and pharmaceutical QC labs
- Nanoparticle synthesis and colloidal stability testing requiring ultra-low ionic strength and organic residue
FAQ
What feed water sources are compatible with Genie PURIST?
Genie PURIST requires pre-purified feed water—specifically EDI effluent, RO permeate, or distilled water—with conductivity ≤5 µS/cm. It is not designed for direct tap water connection.
Does the system support 21 CFR Part 11 compliance?
Yes—when configured with password-protected user roles, electronic signatures, and immutable audit trails, Genie PURIST satisfies key technical controls outlined in FDA 21 CFR Part 11 and EU Annex 11 for electronic records and signatures.
How is TOC measured and validated?
TOC is quantified using a patented UV/persulfate oxidation module followed by non-dispersive infrared (NDIR) CO₂ detection. Calibration is traceable to NIST SRM 990b; system suitability testing includes sucrose and 1,4-benzoquinone challenge tests per USP .
Can the system integrate with building management systems (BMS)?
Yes—via Modbus TCP or optional 4–20 mA analog outputs, Genie PURIST provides real-time status signals (flow, alarm, UV lamp status) for integration into facility-wide monitoring platforms.
What validation documentation is provided?
Each unit ships with Factory Acceptance Test (FAT) report, IQ/OQ protocols (user-executable), and a Certificate of Conformance referencing ISO 9001:2015 and ISO/IEC 17025:2017 calibration practices for onboard sensors.
