NeuronBC PTFE-NWF Pharmaceutical-Grade Hydrophobic PTFE Filter Cartridge
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Model | PTFE-NWF |
| Filtration Rating | 0.2 µm (liquid), <0.01 µm (gas), <0.003 µm (dual-layer) |
| Max Operating Temperature | 90 °C @ 0.20 MPa |
| Sterilization | 121 °C, 30 min (≥50 cycles) |
| Forward Pressure Rating | 0.42 MPa @ 25 °C |
| Reverse Pressure Rating | 0.21 MPa @ 25 °C |
| Endotoxin Level | <0.25 EU/mL |
| Extractables | <10 mg per 10-inch cartridge (Φ69 mm) |
| Chemical Resistance | Broad compatibility with acids, bases, and organic solvents |
Overview
The NeuronBC PTFE-NWF Pharmaceutical-Grade Hydrophobic PTFE Filter Cartridge is engineered for critical sterile gas and solvent filtration in regulated biopharmaceutical, vaccine, and aseptic manufacturing environments. Constructed with a hydrophobic polytetrafluoroethylene (PTFE) membrane using non-woven support (NWF) architecture, this cartridge operates on the principle of size-exclusion and surface capture, delivering deterministic retention of microorganisms—including bacteria, mycoplasma, and viral aggregates—without wetting or breakthrough under humid or condensing conditions. Unlike hydrophilic membranes such as PVDF or cellulose esters, the intrinsic hydrophobicity of PTFE ensures stable bubble point integrity during gas filtration, even after prolonged exposure to ambient humidity or trace condensate. Its design conforms to the physical and functional requirements of ISO 13408-2 (sterile filtration of gases) and supports compliance with FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) and EU GMP Annex 1 (2022), particularly for vent filtration, tank blanketing, and compressed air purification.
Key Features
- Hydrophobic PTFE membrane with validated 0.2 µm liquid-rated retention and sub-0.01 µm performance in gas-phase applications; dual-layer configuration achieves <0.003 µm effective rating for high-risk process gases
- Robust thermal stability: rated for continuous operation up to 90 °C at 0.20 MPa differential pressure; withstands ≥50 cycles of saturated steam sterilization at 121 °C for 30 minutes without structural degradation or integrity loss
- High mechanical resilience: forward pressure tolerance of 0.42 MPa and reverse pressure tolerance of 0.21 MPa at 25 °C, enabling use in high-flow, high-backpressure systems including bioreactor exhaust lines and lyophilizer condenser vents
- Comprehensive extractables and leachables profile: meets USP and Class VI biological reactivity criteria; total extractables <10 mg per standard 10-inch (Φ69 mm) cartridge; endotoxin level <0.25 EU/mL per USP
- Pre-shipment integrity testing performed on 100% of units via automated diffusion or pressure hold test per ASTM F838-22, with full traceability and certificate of conformance included
Sample Compatibility & Compliance
The PTFE-NWF cartridge exhibits broad chemical compatibility across pH 1–14 and common organic solvents including ethanol, isopropanol, acetone, acetonitrile, and ethyl acetate—making it suitable for solvent-based formulation filtration and CIP/SIP system venting. It is certified compliant with USP Class VI plastic requirements for implantable and parenteral contact applications. All materials of construction—including housing, gaskets, and membrane—are documented per ICH Q5E and Q5F for biocompatibility and extractables profiling. The filter meets ISO 9001:2015 manufacturing controls and supports audit readiness for FDA 21 CFR Part 11 (when paired with validated electronic batch records), EU Annex 1 (Section 8.76–8.80 on filter validation), and WHO TRS 986 Annex 3 (sterile filtration qualification). Each lot undergoes particulate shedding assessment per USP and microbial retention validation per ASTM F838-22 using Brevundimonas diminuta (ATCC 19146) for liquid and Aspergillus niger spores for gas challenge.
Software & Data Management
While the PTFE-NWF cartridge itself is a passive, single-use component, its integration into automated process systems enables full digital traceability. When deployed with NeuronBC-compatible filter housings equipped with integrated pressure transducers and temperature sensors, real-time differential pressure monitoring, cycle counting, and sterilization log export are supported via Modbus TCP or 4–20 mA analog output. Integrity test data—including bubble point, diffusion rate, and pressure hold results—can be imported into LIMS or MES platforms compliant with 21 CFR Part 11 through CSV or XML export. Full documentation packages include filter-specific CoA, CoC, bioburden reports, and validation support dossiers aligned with ISPE Baseline Guide Volume 4 (Sterile Product Manufacturing) and PDA Technical Report No. 40 (Filter Validation).
Applications
- Sterile venting of bioreactors, fermenters, and stainless-steel storage tanks during upstream and downstream processing
- Compressed air, nitrogen, and CO₂ line filtration for aseptic filling lines and isolator environments
- Final solvent sterilization in API synthesis and formulation suites (e.g., ethanol, DMSO, THF)
- Lyophilization chamber and condenser vent filtration under vacuum and steam-in-place conditions
- Pharmaceutical-grade clean steam trap venting and HVAC HEPA pre-filtration in Grade A/B environments
FAQ
Can this filter be used for both gas and liquid sterilization? Why?
Yes—the hydrophobic PTFE membrane maintains integrity in both phases due to its intrinsic water-repellent surface energy (>110° contact angle). In gas streams, it resists wetting from condensate; in liquids, it functions as a terminal 0.2 µm sterilizing filter when pre-wetted with compatible alcohol or fluorinated solvent.
How many steam sterilization cycles can the cartridge endure without integrity loss?
Validated for ≥50 cycles of saturated steam at 121 °C for 30 minutes, per manufacturer’s accelerated aging and post-cycle integrity testing protocol (ASTM F838-22).
Is the filter compatible with aggressive cleaning agents such as sodium hydroxide or peracetic acid?
Yes—PTFE demonstrates exceptional resistance to 1–2 M NaOH and ≤0.5% peracetic acid at ambient temperatures; extended exposure above 60 °C requires case-specific evaluation.
What documentation accompanies each shipment?
Each box includes a Certificate of Conformance, Certificate of Sterility (if gamma-irradiated), Certificate of Integrity Test, USP Class VI report, and extractables summary per lot number.
Does NeuronBC provide filter validation support for regulatory submissions?
Yes—customized validation protocols, microbial retention reports, and risk assessments aligned with FDA, EMA, and PMDA expectations are available upon request and subject to confidentiality agreement.
