NeuronBC NL Folded Nylon Membrane Cartridge Filter
| Brand | NeuronBC |
|---|---|
| Model | NL |
| Filter Material | Nylon 6 / Nylon 66 |
| Pore Sizes | 0.1 µm, 0.22 µm, 0.45 µm, 0.65 µm, 0.8 µm, 1.2 µm |
| Filtration Area | 0.60 m² |
| Bubble Point (0.22 µm) | ≥ 0.28 MPa |
| Bubble Point (0.45 µm) | ≥ 0.18 MPa |
| Max Operating Pressure (Forward) | 0.42 MPa @ 25°C |
| Max Service Temperature | ≤ 65°C @ 0.21 MPa |
| Steam Sterilization | 121°C, 0.1 MPa, 30 min per cycle (up to 30 cycles) |
| Delta-P Replacement Threshold | 0.20 MPa |
| Housing & Endcaps | Polypropylene (PP) |
| Core Support | 304 or 316 Stainless Steel |
| Internal Support Layer | Imported Polyester Nonwoven |
| Seal Materials | Silicone or Fluoroelastomer (FKM) |
| Pure Water Flow Rate (ΔP = 0.01 MPa) | 3.3 L/min (0.22 µm), 5.1 L/min (0.45 µm) |
| Bacterial Retention | ≥ 10⁷ CFU/cm² |
| Integrity Test Method | Forward Flow / Bubble Point |
| Compliance | GMP-compliant manufacturing, pre-sterilized options available, fully traceable lot documentation |
Overview
The NeuronBC NL Folded Nylon Membrane Cartridge Filter is a high-integrity, single-use filtration solution engineered for critical liquid clarification and sterilizing-grade applications in biopharmaceutical, diagnostic reagent, and fine chemical manufacturing environments. Constructed using hydrophilic nylon 6 or nylon 66 microporous membranes, the NL series eliminates the need for pre-wetting—reducing process time and operator variability. Its folded pleat geometry maximizes effective filtration area (0.60 m² per 10-inch cartridge) while maintaining low differential pressure and high throughput. The membrane is thermally bonded—not solvent-adhered—ensuring zero extractables, no fiber shedding, and full compliance with current Good Manufacturing Practice (cGMP) requirements for pharmaceutical water systems and sterile drug product manufacturing.
Key Features
- Hydrophilic Nylon Membrane: Inherently wettable without pre-flushing; immediate flow initiation upon system pressurization.
- Thermal Welding Construction: No adhesives or binders used in pleat assembly—eliminates risk of leachables and particulate generation.
- Multi-Pore Size Portfolio: Available in six validated pore ratings (0.1, 0.22, 0.45, 0.65, 0.8, and 1.2 µm) to support coarse prefiltration, clarifying filtration, and terminal sterilizing applications.
- GMP-Aligned Manufacturing: Produced in ISO Class 7 cleanrooms; each lot undergoes 100% integrity testing via forward flow or bubble point methods prior to release.
- Robust Thermal Stability: Rated for repeated steam-in-place (SIP) cycles—up to 30 cycles at 121°C/0.1 MPa—without structural degradation or loss of retention performance.
- Chemical Compatibility: Demonstrated compatibility with aqueous buffers, organic solvents (e.g., IPA, acetone, THF), and aggressive formulations including photoresists and high-purity etchants.
Sample Compatibility & Compliance
The NL cartridge is validated for use across a broad range of bioprocess and analytical workflows. It meets ASTM F838-20 criteria for bacterial retention (≥10⁷ CFU/cm² challenge with Brevundimonas diminuta) at all rated pore sizes. All configurations are manufactured under documented quality systems aligned with ISO 9001 and ISO 13485. Lot-specific Certificates of Conformance (CoC) and Certificates of Analysis (CoA) are supplied, including full integrity test records and endotoxin limits (<0.25 EU/mL). For regulated environments, the filter supports FDA 21 CFR Part 11–compliant electronic batch records when integrated with validated SCADA or MES platforms. Sterile versions are gamma-irradiated (25–35 kGy) and supplied double-bagged in ISO 5 packaging.
Software & Data Management
While the NL cartridge itself is a passive hardware component, its qualification and lifecycle management integrate seamlessly into digital quality ecosystems. NeuronBC provides standardized test data templates compatible with LIMS (e.g., LabWare, Thermo Fisher SampleManager) and QMS platforms (e.g., MasterControl, Veeva Vault). Batch-level integrity test results—including measured bubble points, diffusion rates, and pressure decay profiles—are structured for automated import and trending. Optional QR-coded labels enable traceability from raw material lot to final installation, supporting audit readiness for GLP, GMP, and ISO 17025 assessments.
Applications
- Final filtration of purified water (PW), water for injection (WFI), and clean steam condensate in pharmaceutical utilities.
- Sterile filtration of cell culture media, buffers, and chromatography eluents in upstream and downstream bioprocessing.
- Clarification and sterilization of ophthalmic solutions, injectables, and lyophilized drug product intermediates.
- Filtration of high-value electronic chemicals—including photoresists, developers, and etchants—in semiconductor fabrication.
- Polishing filtration of wine, spirits, and functional beverages to achieve microbiological stability without flavor stripping.
- Pre-filtration of HPLC mobile phases and ICP-MS standards to protect sensitive analytical columns and nebulizers.
FAQ
Is the NL cartridge suitable for autoclaving?
Yes—when installed in compatible polypropylene housings, the NL cartridge withstands repeated autoclave cycles (121°C, 0.1 MPa, 30 min) up to 30 times. Repeated exposure beyond this limit may affect seal integrity and should be qualified per user SOP.
What is the maximum recommended operating temperature under pressure?
The cartridge maintains structural and retention integrity up to 65°C at sustained differential pressures ≤ 0.21 MPa. Higher temperatures require derating per manufacturer’s thermal-pressure derating curve.
Can the NL filter be used for organic solvent filtration?
Yes—nylon exhibits broad compatibility with polar and moderately non-polar solvents. A full chemical compatibility matrix is available upon request and must be consulted prior to use with halogenated or strong oxidizing agents.
How is integrity testing performed post-installation?
Standard protocols include forward flow (diffusion) testing for hydrophilic membranes under low-pressure conditions or bubble point testing at elevated pressure. Test parameters must align with the selected pore size and are defined in ASTM F316-21 and PDA Technical Report No. 26.
Are custom lengths or interface configurations available?
Yes—NeuronBC offers 5-inch, 10-inch, 20-inch, and 30-inch cartridges with standard 222 or 226 end caps. Custom configurations—including sanitary clamp (DIN 11851), tri-clamp, or threaded interfaces—can be engineered under NRE agreement.
