Me-Pak Ultra-Pure Water Cartridge A
| Brand | Deepflow |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (PRC) |
| Model | CYPAKMETEX |
| Pricing | Available Upon Request |
Overview
The Me-Pak Ultra-Pure Water Cartridge A (Model CYPAKMETEX) is a high-performance, single-use polishing cartridge engineered for integration into modular ultra-pure water (UPW) distribution systems in analytical and life science laboratories. Designed as a final-stage purification component, it operates downstream of primary reverse osmosis (RO) and electrodeionization (EDI) units to remove trace ionic, organic, particulate, and microbial contaminants—ensuring consistent delivery of Type I ultrapure water per ISO 3696:1987, ASTM D1193-20, and CLSI EP21-A guidelines. Its core architecture employs a multi-layered composite media bed comprising mixed-bed ion exchange resins, sub-micron depth filtration matrix, and endotoxin-retentive activated carbon, configured to achieve <0.1 EU/mL endotoxin levels, <5 ppb total organic carbon (TOC), and resistivity ≥18.2 MΩ·cm at 25 °C.
Key Features
- Final-polishing configuration optimized for point-of-use (POU) or loop-loop bypass applications in centralized UPW networks
- Pre-validated, pre-packed media with lot-specific Certificate of Analysis (CoA) including TOC leachables, silica breakthrough profile, and bacterial retention test data (≥log 4 reduction of Pseudomonas diminuta per ASTM F838-22)
- Integral 0.22 µm hydrophilic polyethersulfone (PES) membrane vent filter to prevent atmospheric ingress during installation and storage
- Pressure-rated housing (max 6.0 bar @ 25 °C) with sanitary tri-clamp (DIN 11851) end connections for seamless integration into stainless-steel distribution loops
- Integrated RFID tag enabling automated cartridge lifecycle tracking, usage logging, and compatibility verification with Deepflow’s SmartLoop™ monitoring platform
- Compliant with USP Water for Pharmaceutical Purposes and EP 2.2.48 Purified Water specifications when used within validated system parameters
Sample Compatibility & Compliance
The Me-Pak Cartridge A is compatible with all Deepflow CY-series UPW generators and third-party systems delivering feed water meeting minimum inlet specifications: conductivity ≤1.0 µS/cm, TOC ≤50 ppb, and SDI ≤3. It is not intended for direct use with raw municipal or well water. Each cartridge undergoes full functional testing per ISO 9001:2015 and ISO 13485:2016 quality management protocols. Batch documentation includes full traceability to resin synthesis, carbon activation, and membrane manufacturing suppliers. The device supports GLP/GMP audit readiness through batch-specific validation support packages, including Installation Qualification (IQ) templates and Operational Qualification (OQ) challenge test protocols aligned with FDA 21 CFR Part 11 electronic record requirements.
Software & Data Management
When deployed with Deepflow SmartLoop™ controllers (v3.2+), the embedded RFID enables automatic recognition, runtime metering, and predictive replacement alerts based on cumulative flow volume and real-time resistivity decay modeling. All operational logs—including pressure differential trends, temperature-compensated resistivity, and TOC proxy readings—are timestamped, digitally signed, and exportable in CSV or PDF formats compliant with ALCOA+ principles. Audit trails are immutable and retain full metadata (user ID, action type, timestamp, system state), satisfying requirements for 21 CFR Part 11 Subpart B electronic signature and record retention.
Applications
- HPLC, UHPLC, and LC-MS mobile phase preparation where silica and metal ion interference must be minimized
- Cell culture media formulation requiring endotoxin-free water per ISO 13485 biomanufacturing standards
- Atomic absorption spectroscopy (AAS) and inductively coupled plasma mass spectrometry (ICP-MS) blank integrity assurance
- Pharmaceutical stability testing per ICH Q5C guidelines, where water purity directly impacts degradation pathway interpretation
- Calibration of conductivity and TOC analyzers in metrology laboratories accredited to ISO/IEC 17025
FAQ
What is the recommended maximum service life under continuous operation?
Typical service life is 6–12 months depending on feed water quality and daily throughput; replacement is triggered automatically by SmartLoop™ upon reaching 95% predicted capacity or >0.5 bar pressure differential.
Can this cartridge be sterilized in place (SIP)?
No—CYPAKMETEX is a non-SIP, single-use cartridge; steam sterilization would degrade ion exchange functionality and void warranty.
Is it compatible with ozone-based distribution loop sanitization?
Yes—validated for intermittent ozone exposure up to 0.2 ppm residual concentration; extended exposure (>2 hours) requires post-sanitization flushing per Deepflow Technical Bulletin TB-CYPAK-07.
Does the CoA include heavy metal extraction data?
Yes—each CoA reports ICP-MS quantification of leachable Na⁺, K⁺, Ca²⁺, Mg²⁺, Fe³⁺, Ni²⁺, Cr⁶⁺, and Pb²⁺ at pH 5.0 and 8.0 elution conditions.
How is media exhaustion monitored without inline sensors?
SmartLoop™ uses dynamic resistivity decay algorithms calibrated against accelerated aging studies; field validation confirms ±2.3% accuracy in predicting silica and sodium breakthrough endpoints.
