Endotoxin-Removal Terminal Filter for Ultra-Pure Water Systems

Overview

The Deepflow CYUFBI001 Endotoxin-Removal Terminal Filter is a sterile, single-use, low-protein-binding cartridge engineered for final-stage purification in ultrapure water (UPW) distribution systems. It operates on the principle of size-exclusion and high-affinity ligand binding—integrating proprietary immobilized polymyxin B or LPS-binding peptide matrices with sub-20 nm pore architecture—to selectively capture and irreversibly bind bacterial endotoxins (lipopolysaccharides, LPS) while permitting unrestricted passage of water molecules and dissolved ions. Unlike conventional 0.22 µm sterilizing-grade filters that only remove intact microorganisms, the CYUFBI001 targets free endotoxin aggregates as small as 1–5 nm, ensuring endotoxin levels ≤ 0.001 EU/mL in effluent water—a critical requirement for cell culture media preparation, monoclonal antibody formulation, PCR reagent synthesis, and analytical instrument feedwater (e.g., LC-MS, ICP-MS). Its placement at the point-of-use—immediately upstream of sensitive equipment or dispensing manifolds—prevents post-purification contamination from biofilm sloughing or leaching in stainless-steel or PVC piping.

Key Features

• Terminal endotoxin removal with validated retention efficiency ≥ 4-log reduction (≥99.99%) of E. coli O113 LPS across flow rates up to 2.5 L/min at 25 °C
• Low total organic carbon (TOC) extractables (<0.5 ppb), certified non-pyrogenic per USP and EP 2.6.14
• Hydrophilic polyethersulfone (PES) membrane with asymmetric structure—minimizes pressure drop and extends service life under continuous UPW recirculation
• Pre-sterilized via gamma irradiation (25–35 kGy); integrity-tested using forward flow (FF) and water intrusion pressure (WIP) methods per ASTM F838-22
• Integrated RFID tag for digital batch traceability, including manufacturing date, sterilization lot, and pre-use integrity test records
• Compact 10-inch sanitary housing interface compatible with standard 222 mm × 28 mm cartridge dimensions (DIN 1988-100 / ASME BPE 2023)

Sample Compatibility & Compliance

The CYUFBI001 is validated for use with Type I ultrapure water (resistivity ≥ 18.2 MΩ·cm at 25 °C, TOC ≤ 5 ppb, bacteria ≤ 0.1 CFU/mL) generated by integrated EDI + UV + ultrafiltration systems. It exhibits chemical compatibility with UPW system sanitants including ozone (≤ 0.1 ppm residual), hydrogen peroxide vapor (HPV), and hot water (≥ 80 °C for ≤ 30 min). The device conforms to ISO 13408-1 (aseptic processing), meets material biocompatibility requirements per ISO 10993-5 and -12, and supports GLP/GMP audit readiness through full documentation packages—including Certificate of Conformance, Certificate of Irradiation, and Endotoxin Removal Validation Report (per ISO 11737-1 Annex D). While not FDA-cleared as a medical device, its performance data aligns with USP pyrogen testing thresholds and supports compliance with FDA 21 CFR Part 11 when paired with compliant SCADA logging.

Software & Data Management

As a passive filtration component, the CYUFBI001 does not incorporate embedded electronics or firmware. However, its integrated RFID tag enables interoperability with facility-wide asset management platforms (e.g., Siemens Desigo CC, Rockwell FactoryTalk AssetCentre) via ISO/IEC 15693–compliant readers. Each cartridge’s unique ID links to a cloud-hosted digital dossier containing real-time usage metrics (cumulative volume processed, temperature exposure history), automated replacement alerts triggered at 1,200 L or 90 days (whichever occurs first), and electronic signatures for integrity test verification. Audit trails comply with ALCOA+ principles and support 21 CFR Part 11-compliant electronic record retention when deployed within validated IT infrastructure.

Applications

• Final polishing step in pharmaceutical water-for-injection (WFI) and purified water (PW) distribution loops
• Point-of-use protection for bioreactor feed lines, buffer preparation stations, and fill-finish isolators
• Guard filtration for HPLC mobile phase reservoirs and ICP-MS nebulizer inlets
• Research-grade water supply in stem cell laboratories, CRISPR editing workflows, and single-cell sequencing core facilities
• Compliance-enabling upgrade for legacy UPW systems lacking dedicated endotoxin control

FAQ

What is the maximum recommended flow rate for the CYUFBI001?

Maximum sustained flow rate is 2.5 L/min at 25 °C with inlet pressure ≤ 3.5 bar; transient spikes up to 4.0 L/min are permissible for ≤ 5 minutes.
Can this filter be reused after steam sterilization?

No. The CYUFBI001 is designed as a single-use, gamma-sterilized cartridge. Reuse or autoclaving compromises ligand stability and membrane integrity.
Does it remove nucleases or DNase/RNase activity?

No. The CYUFBI001 is specific to endotoxin removal; nuclease removal requires dedicated nuclease-depleting resins or UV-C photolysis modules.
How is integrity verified post-installation?

Forward flow test (FF) at 3.0 psi nitrogen pressure, with pass criterion ≤ 0.05 mL/min leakage; WIP test optional for hydrophobic challenge validation.
Is the housing material compliant with ASME BPE surface finish standards?

Yes—standard housing uses electropolished 316L SS with Ra ≤ 0.4 µm, fully traceable to mill test reports.