Sterile-Grade Polyethersulfone (PES) Filter Cartridge – NeuronBC Micro Series
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | PES |
| Price Range | USD 140 – 1,400 (FOB) |
| Membrane Material | Hydrophilic, Asymmetric Sulfonated Polyethersulfone |
| Sterilization Compatibility | Steam-in-Place (SIP) & Autoclave (121°C, 30 min) |
| Max Operating Temperature | 90°C @ 0.20 MPa |
| Forward Pressure Differential | 0.40 MPa (25°C) |
| Reverse Pressure Differential | 0.21 MPa (25°C) |
| Endotoxin Level | <0.25 EU/mL |
| Extractables | <30 mg per 10-inch Φ69 mm cartridge |
| Biocompatibility | USP <88> Class VI In Vivo Reactivity Testing |
| Water Contact Safety | Compliant with GB/T 17219–2001 (Drinking Water Safety) |
Overview
The NeuronBC Micro Series Sterile-Grade Polyethersulfone (PES) Filter Cartridge is an engineered solution for validated, high-integrity terminal sterilizing filtration in regulated biopharmaceutical manufacturing environments. Designed and manufactured to meet the stringent requirements of current Good Manufacturing Practice (cGMP), this cartridge utilizes a hydrophilic, asymmetric sulfonated PES membrane—sourced from globally qualified suppliers—to deliver consistent microbial retention (≥ log4 reduction of Brevundimonas diminuta, ATCC 19146) under dynamic process conditions. Its non-pyrogenic construction, low protein binding characteristics (<5 ng/cm²), and broad chemical compatibility (pH 3–11) make it suitable for both prefiltration and final sterile filtration of sensitive biologics—including monoclonal antibodies, recombinant proteins, vaccines, and cell culture media—without compromising product integrity or filter performance.
Key Features
- Hydrophilic asymmetric PES membrane with high porosity and uniform pore geometry, enabling superior flux stability and extended service life under constant differential pressure
- Fully validated integrity test compliance: each cartridge undergoes pre-shipment bubble point, diffusion, and pressure hold testing per ASTM F838-22 and ISO 13408-2
- Robust dual-layer membrane architecture fabricated from identical PES material—eliminating interlayer delamination risks during repeated thermal cycling
- Steam-in-place (SIP) compatible up to 121°C for 30 minutes; validated for ≥5 consecutive sterilization cycles without loss of retention efficiency or structural integrity
- Low endotoxin content (<0.25 EU/mL) and minimal extractables (<30 mg per standard 10-inch Φ69 mm unit), supporting USP and compliance
- Non-cytotoxic and non-sensitizing per ISO 10993-5 and ISO 10993-10, confirmed via in vivo reactivity testing (USP Class VI)
Sample Compatibility & Compliance
This PES filter cartridge demonstrates proven compatibility with a wide range of biopharmaceutical process streams—including aqueous buffers, ethanol/water mixtures, isotonic saline solutions, and low-concentration organic solvents (e.g., ≤20% IPA). It is routinely deployed in applications requiring adherence to ICH Q5A(R2), FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, and EU Annex 1 (2022). All units are supplied with full traceability documentation, including Certificate of Conformance, Certificate of Validation Support Data, and batch-specific integrity test records. The design supports audit readiness for FDA 21 CFR Part 11-compliant electronic data management systems when integrated with validated SCADA or MES platforms.
Software & Data Management
While the cartridge itself is a passive filtration component, NeuronBC provides comprehensive digital support for qualification workflows. Customers receive standardized IQ/OQ/PQ protocol templates aligned with ASTM E2500-13 and ISPE Baseline Guide Vol. 4. Filter usage logs, integrity test results, and sterilization cycle histories can be imported into LIMS or electronic batch record (EBR) systems via CSV or XML export. Optional integration with NeuronBC’s FilterTrack™ cloud dashboard enables real-time monitoring of installed filter lifecycle status, predictive maintenance alerts, and automated report generation compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Terminal sterilizing filtration of injectables: large-volume parenterals (LVPs), small-volume parenterals (SVPs), ophthalmic solutions, and lyophilized drug intermediates
- Pre-filtration and polishing of cell culture harvests, clarified monoclonal antibody (mAb) bulk solutions, and viral vector preparations
- Sterile filtration of serum-free and chemically defined cell culture media, transfection reagents, and buffer solutions
- Final filtration of vaccine antigens (e.g., subunit, mRNA-LNP formulations), blood-derived therapeutics (IVIG, albumin), and diagnostic reagents
- Water-for-injection (WFI) and purified water distribution loop polishing in pharmaceutical utilities
FAQ
Is this filter cartridge compliant with FDA 21 CFR Part 11 for electronic records?
Yes—when used with validated data acquisition systems (e.g., Integrity Testers with audit-trail enabled firmware), all associated test records meet Part 11 requirements for electronic signatures and record retention.
Can the cartridge be reused after sterilization?
No—it is designed for single-use, multi-cycle sterilization applications; reuse beyond validated cycles is not permitted under cGMP guidelines.
What is the maximum allowable forward pressure differential at operating temperature?
0.40 MPa at 25°C; derating applies above 40°C per NeuronBC Technical Bulletin TB-PES-07.
Does the filter require pre-wetting with alcohol prior to aqueous use?
No—the hydrophilic sulfonated PES membrane wets spontaneously in water and standard buffers, eliminating alcohol priming steps and associated validation complexity.
Are filter integrity test parameters provided per batch?
Yes—each shipment includes a Certificate of Conformance listing nominal bubble point, water intrusion pressure, and diffusion rate values measured per ISO 13408-2.
