IQ3/5 Kit (1×Gapak, 1×Qupak, 1×Vent Filter)
| Brand | Deepflow |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (PRC) |
| Model | CYIQ700XPKIT |
| Pricing | Available Upon Request |
Overview
The IQ3/5 Kit is a modular consumables assembly designed exclusively for integration with Deepflow’s CYIQ700XP series ultra-pure water systems. This kit comprises three essential, pre-sterilized components: one Gapak (a high-capacity, low-leaching polypropylene storage bag for point-of-use ultra-pure water reservoirs), one Qupak (a sterile, endotoxin-free, 0.22 µm PES membrane-vented water delivery pouch optimized for sensitive analytical applications), and one Vent Filter (a hydrophobic, PTFE-based 0.2 µm filter cartridge engineered to prevent microbial ingress while enabling pressure equilibration during water dispensing). The system operates on a closed-loop, single-use principle—eliminating the risk of biofilm formation, airborne contamination, or operator-induced variability associated with reusable tanks or open reservoirs. It supports continuous generation and storage of Type I+ ultrapure water (resistivity ≥18.2 MΩ·cm at 25 °C, TOC < 5 ppb, bacteria < 0.1 CFU/mL, endotoxins < 0.001 EU/mL) in compliance with ASTM D1193-20, ISO 3696:1987, and CLSI EP21-A guidelines for critical laboratory water.
Key Features
- Pre-assembled, gamma-irradiated sterile configuration ensures immediate deployment without validation overhead.
- Gapak features welded seam integrity tested per ASTM F1886/F1886M and certified for ≤1.0 ng/cm² total extractables (measured by USP ).
- Qupak incorporates a dual-stage venting architecture: primary hydrophobic PTFE membrane (0.2 µm) + secondary HEPA-grade support layer (0.3 µm), validated for >99.999% retention of airborne microorganisms (ISO 14644-1 Class 5 compatible).
- Vent Filter utilizes a pleated, surface-loaded PTFE membrane with symmetric pore structure—validated for non-shedding performance under differential pressures up to 2.5 bar (EN 16893:2017 compliant).
- All components are individually traceable via laser-etched batch codes; full CoA (Certificate of Analysis) and CoC (Certificate of Conformance) provided with each kit.
- Compatible with Deepflow CYIQ700XP system’s automated fill/dispense protocol and integrated pressure-sensing feedback loop.
Sample Compatibility & Compliance
The IQ3/5 Kit is validated for use with ultrapure water intended for high-sensitivity applications including LC-MS mobile phase preparation, ICP-MS calibration standard dilution, cell culture media formulation, and molecular biology workflows (e.g., qPCR, NGS library prep). It meets material biocompatibility requirements per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). All plastic components comply with USP Class VI and FDA 21 CFR 177.1520 (food-contact polymers). System-level validation documentation supports GLP and GMP environments—including audit-ready records for FDA 21 CFR Part 11 electronic signature compliance when paired with CYIQ700XP’s embedded data logger.
Software & Data Management
When installed on a CYIQ700XP platform, the IQ3/5 Kit triggers automatic recognition via RFID-tagged packaging. The onboard control software logs installation timestamp, batch ID, and cumulative dispense volume. Usage history—including fill cycles, pressure transients across the vent filter, and real-time conductivity/TOC trend correlation—is stored locally and exportable via USB or Ethernet (CSV/Excel format). Audit trail functionality complies with ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Optional cloud synchronization (via Deepflow SecureLink™) enables remote fleet monitoring and predictive maintenance alerts based on filter saturation modeling.
Applications
- Preparation of HPLC and UHPLC mobile phases requiring sub-ppb organic carbon control.
- Dilution of certified reference materials (CRMs) for elemental analysis (ICP-OES, ICP-MS) where chloride and silica leachables must remain below detection limits.
- Formulation of serum-free and low-endotoxin cell culture media for stem cell expansion and monoclonal antibody production.
- Routine calibration of total organic carbon (TOC) analyzers using zero-water blanks traceable to NIST SRM 3183.
- On-demand generation of RNase/DNase-free water for RNA isolation and CRISPR-Cas9 editing workflows.
FAQ
Is the IQ3/5 Kit compatible with legacy Deepflow water systems?
No. This kit is mechanically and electronically engineered only for the CYIQ700XP series, which features proprietary bayonet-style coupling and RFID-enabled consumables authentication.
What is the maximum recommended shelf life prior to first use?
24 months from date of manufacture when stored unopened at 15–25 °C, protected from UV exposure and ambient humidity >60% RH.
Can the Vent Filter be reused after sterilization?
No. The Vent Filter is a single-use, pre-sterilized component. Reuse or autoclaving compromises membrane integrity and voids all performance certifications.
Does the kit include documentation required for ISO 17025 accreditation?
Yes. Each shipment includes a full technical dossier: CoA, CoC, biocompatibility reports, extractables profile, and installation qualification (IQ) checklist aligned with ISO/IEC 17025:2017 clause 6.4.3.
How is leak integrity verified during installation?
The CYIQ700XP performs an automated pressure-hold test (1.2 bar for 120 seconds) immediately after priming; any deviation >0.02 bar/min triggers an audible alert and halts dispensing until manual verification.
