SQ Terminal Filter

Overview

The Deepflow CYPAKFINM1 SQ Terminal Filter is a high-integrity, point-of-use (POU) filtration device engineered for the final stage of ultra-pure water (UPW) distribution systems in pharmaceutical, biotechnology, semiconductor, and analytical laboratory environments. Designed to meet stringent purity requirements for Type I water per ISO 3696 and ASTM D1193, this terminal filter employs a hydrophilic polyethersulfone (PES) or mixed cellulose ester (MCE) membrane—depending on configuration—with a nominal retention rating of 0.22 µm (optionally 0.1 µm for critical applications). Its function is not merely particulate removal but also the reliable elimination of viable microorganisms, endotoxins, and submicron colloidal contaminants immediately prior to point-of-delivery—thereby preventing recontamination after primary UPW generation and storage. The filter operates under laminar flow conditions and is validated for use in continuous recirculating loops with low pressure drop (<0.3 bar at 2 L/min), ensuring minimal impact on system hydraulics while maintaining consistent flow stability.

Key Features

• Robust, single-use, pre-sterilized cartridge design with integral housing and integrated O-ring seal—eliminates assembly errors and reduces risk of bypass leakage.
• Membrane surface area optimized for high throughput (up to 10 L/min at rated differential pressure) without compromising retention efficiency or increasing extractables.
• Low total organic carbon (TOC) leachables and non-pyrogenic construction—validated per USP and , supporting compliance in parenteral manufacturing and cell culture media preparation.
• Integrated integrity test port enables rapid, non-destructive forward flow or bubble point testing in situ—fully traceable and aligned with Annex 1 (EU GMP) and FDA guidance on filter validation.
• Compact, modular footprint (standard 10-inch length, 2.75-inch diameter) compatible with common sanitary clamp (Tri-Clamp®) or threaded (NPT) connections for seamless integration into existing UPW piping networks.
• Batch-certified documentation package includes Certificate of Conformance, Certificate of Sterilization (with radiation dose or autoclave cycle log), and extractables profile report per USP .

Sample Compatibility & Compliance

The CYPAKFINM1 is validated for use with Type I ultra-pure water meeting resistivity ≥18.2 MΩ·cm at 25 °C, total silica <1 ppb, bacterial count <0.1 CFU/mL, and endotoxin levels <0.001 EU/mL. It is compatible with stainless steel (316L), PVDF, and fluoropolymer-lined distribution systems and exhibits no adverse interaction with ozone, hydrogen peroxide vapor (HPV), or ultraviolet (UV) treatment stages upstream. Regulatory alignment includes adherence to ISO 14644-1 (cleanroom air classification), ISO 20417 (medical device labeling), and ICH Q5A(R2) for viral clearance validation support. All materials comply with REACH and RoHS directives; extractables testing follows ELSIE (Extractables and Leachables Safety Information Exchange) best practices.

Software & Data Management

While the CYPAKFINM1 is a passive, hardware-only filtration component, its deployment is fully supported within digital water management ecosystems. Batch-specific certificates are issued with unique QR-coded identifiers linked to Deepflow’s secure cloud portal—enabling audit-ready access to sterilization records, integrity test logs, and shelf-life expiration tracking. When integrated with programmable logic controllers (PLCs) or SCADA systems via analog 4–20 mA pressure differential sensors (optional accessory), real-time delta-P trending supports predictive maintenance scheduling and automatic alarm triggers per predefined thresholds—facilitating compliance with 21 CFR Part 11 electronic record requirements when paired with validated data acquisition software.

Applications

• Final filtration for WFI (Water for Injection) and Purified Water (PW) loops in sterile pharmaceutical manufacturing suites.
• Point-of-use protection for HPLC mobile phase delivery, ICP-MS sample introduction, and LC-MS solvent lines.
• Critical feed filtration for electrochemical sensors, quartz crystal microbalances (QCM), and atomic layer deposition (ALD) precursor delivery in semiconductor fabs.
• Terminal safeguard in central lab UPW networks supplying cell culture incubators, biosafety cabinets, and automated liquid handlers.
• Backup filtration during routine sanitization cycles or when primary purification modules undergo regeneration or replacement.

FAQ

Is the CYPAKFINM1 suitable for steam-in-place (SIP) cycles?
Yes—it is rated for repeated exposure to saturated steam up to 135 °C for ≤30 minutes, provided pressure ramp rates and cooling profiles follow ASME BPE guidelines.
Can it be used in series with other terminal filters for redundancy?
Yes, though dual 0.22 µm filtration is generally discouraged unless justified by formal risk assessment per ISO 14971; parallel configuration with automatic switchover is preferred for high-availability systems.
What is the recommended service life under continuous operation?
Typical lifespan is 3–6 months depending on upstream water quality and loop microbial load; integrity testing frequency must follow internal SOPs aligned with PDA TR26 and EU Annex 1.
Does Deepflow offer custom membrane material selection?
Yes—alternative membranes including polyvinylidene fluoride (PVDF) and regenerated cellulose (RC) are available for specific chemical compatibility or low-protein-binding requirements.
How is filter integrity verified post-installation?
Forward flow testing is recommended for installed units; bubble point testing may be performed offline if housing permits disassembly without breaking sterility.