IX 03/05 Consumables Kit (1×Gapak, 1×Vent Filter)

Overview

The IX 03/05 Consumables Kit (Model CYIX700XPKIT) is a purpose-engineered replacement package designed exclusively for use with Deepflow’s IX-series ultra-pure water systems—specifically the IX 03 and IX 05 models. This kit supports critical post-purification integrity by maintaining sterile, particle-free water delivery through validated gas venting and secondary containment functions. Unlike generic filtration accessories, the components in this kit are dimensionally and chemically matched to the system’s internal fluidic architecture, ensuring consistent flow dynamics, pressure stability, and compliance with ISO 3696 Class 1 and ASTM D1193 Type I water specifications. The kit does not perform primary purification; rather, it sustains the final barrier against atmospheric contamination and microbial ingress during storage and dispensing phases—key requirements in GLP-compliant analytical laboratories and pharmaceutical QC environments.

Key Features

• Integrated Gapak™ cartridge: A proprietary hydrophobic polytetrafluoroethylene (PTFE) membrane assembly rated for ≥0.22 µm absolute retention, validated for non-pyrogenic, low-extractable performance under continuous low-pressure venting conditions.
• Dual-function vent filter: Combines particulate filtration (≥0.45 µm) with activated carbon adsorption to eliminate trace volatile organic compounds (VOCs) and chlorine residuals that may re-enter the reservoir via ambient air exchange.
• Pre-assembled, sterilizable housing: Designed for autoclave compatibility (121 °C, 20 min, saturated steam), supporting routine validation protocols required under ISO 13485 and FDA 21 CFR Part 820.
• Traceable lot documentation: Each kit includes a Certificate of Conformance (CoC) with batch-specific test data for bacterial retention (per ISO 13408-2), extractables profiling (per USP ), and endotoxin limits (<0.03 EU/mL).
• Plug-and-play installation: Tool-free mounting interface aligns with Deepflow IX-series reservoir manifolds; no recalibration or system downtime required upon replacement.

Sample Compatibility & Compliance

This consumables kit is certified for use only with Deepflow IX 03 and IX 05 ultra-pure water systems operating within nominal flow rates of 0.5–2.0 L/min and reservoir volumes ≤60 L. It is incompatible with reverse osmosis pre-treatment modules or integrated UV oxidation units unless explicitly referenced in Deepflow Technical Bulletin TB-IX-KIT-03/05-Rev.D. The materials comply with USP Class VI biocompatibility standards and meet REACH Annex XIV SVHC screening thresholds. All components are manufactured in an ISO 9001:2015-certified facility in Shanghai and undergo 100% functional leak testing prior to packaging. The kit supports audit readiness for ISO/IEC 17025-accredited labs performing elemental analysis (ICP-MS), HPLC mobile phase preparation, and cell culture media formulation.

Software & Data Management

While the IX 03/05 Consumables Kit itself contains no embedded electronics or firmware, its usage is tracked automatically via Deepflow’s AquaLink™ System Manager software (v4.2+). When installed on a networked IX unit, the system logs replacement timestamps, cumulative runtime hours, and alerts for scheduled maintenance intervals based on manufacturer-recommended service cycles (typically every 6 months or 1,500 operational hours, whichever occurs first). Audit trails are stored with immutable timestamps and user ID attribution, satisfying FDA 21 CFR Part 11 requirements for electronic records and signatures when paired with validated AquaLink™ server configurations.

Applications

• Final-stage protection of ultrapure water reservoirs in life science research labs conducting ELISA, qPCR, and CRISPR-based workflows.
• Maintenance of TOC-sensitive applications including LC-MS grade solvent preparation and trace metal analysis (e.g., EPA Method 200.8).
• Supporting ISO 14644-1 Class 5 cleanroom water dispensing stations where airborne particulate control is mandated.
• Ensuring compliance with pharmacopoeial water quality requirements (USP , EP 2.2.44, JP 2.05) during pharmaceutical water system qualification (IQ/OQ/PQ).
• Extending service life of downstream point-of-use filters and reducing unscheduled downtime in multi-user core facilities.

FAQ

Is this kit compatible with IX 01 or IX 07 systems?
No. The CYIX700XPKIT is mechanically and hydraulically optimized only for IX 03 and IX 05 platforms. Use on other models may compromise seal integrity or pressure regulation.
Can the vent filter be regenerated or cleaned?
No. Both the Gapak cartridge and vent filter are single-use, non-reconditionable components. Reuse violates ISO 13408-2 sterility assurance principles and voids system validation status.
Does the kit include installation instructions or torque specifications?
Yes. A bilingual (English/Chinese) Quick Start Guide is included, specifying hand-tightening protocol (0.8–1.2 N·m) and visual alignment markers for correct orientation.
How is shelf life verified for this kit?
Each sealed pouch bears a printed expiration date calculated from the date of terminal sterilization (EtO or gamma), with a minimum guaranteed shelf life of 36 months when stored at 15–25 °C and ≤60% RH.
Is technical support available outside business hours for urgent replacements?
Deepflow provides 24/7 emergency dispatch for certified distributors in EMEA and APAC regions; response time is contractually defined per regional service agreement (SLA-IX-KIT-EMEA/APAC v3.1).