NeuronBC PTFE Pleated Membrane Cartridge Filter
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Model | PTFE |
| Filtration Rating (Liquid) | 0.22 µm & 0.45 µm |
| Filtration Rating (Gas) | 0.01 µm |
| Bubble Point | ≥ 0.08 MPa (95% IPA) |
| Diffusion Flow | ≤ 5.5 mL/min (60:40 IPA:Water at 0.064 MPa) |
| Gas Flow Rate (Hydrophobic, 0.01 µm) | ≥ 6 m³/min (ΔP = 0.015 MPa at 0.13 MPa inlet) |
| Water Flow Rate (Hydrophilic, 0.22 µm) | ≥ 6.89 L/min (ΔP = 0.01 MPa at 0.13 MPa inlet) |
| Max Operating Pressure (Forward) | 0.42 MPa @ 25°C |
| Max Reverse Pressure | 0.21 MPa @ 25°C |
| Max Service Temperature | 65°C @ 0.21 MPa (Standard), 95°C @ 0.1 MPa (High-Temp Grade) |
| Sterilization | 142°C @ 0.276 MPa (Autoclave) |
| Online Steam | 135°C @ 0.1 MPa, 30 min per cycle (up to 160 cycles) |
| Max ΔP for Replacement | 0.20 MPa |
| Housing Material | Polypropylene (PP) |
| Core Support | PP, 304 SS, or 316 SS |
| End Cap & Connector | PP |
| Support Layer | Imported Polyester Nonwoven |
| Seal Materials | Food-Grade EPDM, Silicone, or FKM |
| Effective Filtration Area | 0.70 m² (10-inch format) |
Overview
The NeuronBC PTFE Pleated Membrane Cartridge Filter is an engineered solution for critical sterile and particulate removal in biopharmaceutical manufacturing, upstream/downstream bioprocessing, and high-purity chemical handling. Designed around hydrophobic or hydrophilic polytetrafluoroethylene (PTFE) membrane media, this cartridge leverages the intrinsic chemical inertness, thermal stability, and low protein-binding characteristics of PTFE to deliver consistent, validated performance under stringent regulatory conditions. Its pleated geometry maximizes active surface area within standard 10-inch (254 mm) housing dimensions, enabling high throughput with low differential pressure—essential for maintaining process efficiency in continuous or batch operations. The filter operates on the principle of size-exclusion-based microfiltration, where pores are precisely manufactured to retain microorganisms (e.g., Brevundimonas diminuta ATCC 19146 for 0.22 µm rating) and submicron particles while permitting unimpeded passage of gases or liquids. All units undergo 100% integrity testing prior to release, ensuring compliance with USP 〈788〉 Particulate Matter in Injections, 〈85〉 Bacterial Endotoxins Test, and ISO 13408-2:2018 requirements for sterile filtration.
Key Features
- Two membrane variants: hydrophobic PTFE for gas and solvent sterilization; hydrophilic PTFE for aqueous stream filtration—both certified non-pyrogenic and low endotoxin (<1 EU/mL)
- Robust mechanical architecture: fully welded construction with no adhesives or binders; zero fiber shedding or extractables under validated operating conditions
- Wide chemical compatibility: resistant to strong oxidizers (e.g., HNO₃, H₂O₂, ClO₂), organic solvents (acetone, THF, DMF), and aggressive bases—validated per ASTM D543 and manufacturer’s Chemical Compatibility Guide
- Thermal resilience: rated for repeated steam-in-place (SIP) cycles up to 135°C at 0.1 MPa for 30 minutes; supports up to 160 SIP cycles without structural degradation
- Regulatory-ready design: compliant with FDA 21 CFR Part 11 data traceability when integrated with compatible integrity test instruments; meets GMP Annex 1 (2022) air filtration specifications for Grade A/B environments
Sample Compatibility & Compliance
This cartridge is validated for use across diverse life science workflows requiring absolute retention of bioburden and particulates. It accommodates compressed air, nitrogen, CO₂, and process gases in bioreactor sparging and tank blanketing applications. For liquid streams, it is suitable for buffer preparation, media sterilization, final product polishing, and high-purity reagent filtration—including those used in cell and gene therapy (CGT) manufacturing. Each lot is accompanied by a Certificate of Conformance (CoC) listing individual bubble point and diffusion flow results, supporting audit readiness for ISO 13485, EU GMP, and PIC/S inspections. Endotoxin levels are confirmed ≤ 0.25 EU/cm² via LAL assay per USP 〈85〉; biocompatibility is verified per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).
Software & Data Management
While the cartridge itself is a passive component, its integrity testing parameters are fully compatible with industry-standard automated filter integrity testers (e.g., Sartorius Integrity Tester, Pall Integrity Checker). When paired with compliant test instrumentation, all bubble point, diffusion, and pressure hold test data—including timestamps, operator IDs, and environmental conditions—can be exported in CSV or PDF formats with full electronic signature support. Audit trails meet FDA 21 CFR Part 11 requirements for electronic records and signatures, including user authentication, change control, and immutable data archiving. Batch-level traceability extends to raw material certifications (e.g., PTFE membrane lot numbers, seal elastomer compendial grade verification), ensuring full supply chain transparency.
Applications
- Sterile air filtration for fermenters, bioreactors, and cleanroom HVAC systems (ISO Class 5–8)
- Final sterile filtration of monoclonal antibodies (mAbs), vaccines, and viral vectors prior to aseptic filling
- Purification of high-value solvents and reagents in oligonucleotide synthesis and small-molecule API manufacturing
- In-line vent filtration for single-use bioprocess bags and fluid management systems
- Compressed gas purification in chromatography systems and analytical instrument gas supplies
FAQ
What validation documentation is provided with each cartridge?
Each unit ships with a Lot-Specific Certificate of Conformance detailing integrity test results (bubble point and diffusion flow), endotoxin assay data, and material traceability. Full validation support packages—including protocol templates for bacterial retention, extractables/leachables, and SIP cycle qualification—are available upon request.
Can this cartridge be used for organic solvent filtration?
Yes. Hydrophobic PTFE exhibits exceptional resistance to alcohols, ketones, esters, and halogenated hydrocarbons. Compatibility must be confirmed against the NeuronBC Chemical Compatibility Chart, especially for prolonged exposure above 60°C or under vacuum conditions.
Is the 0.01 µm gas rating validated per ISO 15711 for aerosol challenge?
The 0.01 µm rating is derived from standardized sodium chloride aerosol challenge testing per ISO 15711-1:2020 and correlates to ≥ log6 reduction of MS2 bacteriophage under defined flow and pressure conditions.
How does the pleated design affect flow dynamics compared to flat-sheet configurations?
The optimized pleat geometry increases effective filtration area by >300% versus equivalent-length flat-sheet elements, reducing specific flux and minimizing fouling-induced pressure rise—critical for extended run times in continuous processes.
Are replacement seals available as spare parts?
Yes. Food-grade EPDM, medical-grade silicone, and fluorocarbon (FKM) O-rings are stocked separately with full material certification (USP Class VI, FDA 21 CFR 177.2600) and lot traceability.
