Otseins AF Series Microporous Filter Membranes
| Brand | Otseins |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | AF-Series |
| Price Range | USD 140 – 1,400 (FOB Tianjin) |
| Available Diameters | 13 mm, 25 mm, 50 mm |
| Pore Sizes | 0.18 µm, 0.22 µm, 0.45 µm, 0.8 µm, 1.2 µm, 1.22 µm |
| Membrane Materials | Mixed Cellulose Ester (MCE), Polyvinylidene Fluoride (PVDF) |
| Hydrophilic/Hydrophobic Variants | Water-compatible (hydrophilic) and solvent-compatible (low-protein-binding hydrophobic) grades |
| Sterilization Compatibility | Gamma irradiation and autoclave (121°C, 20 min) validated for selected configurations |
| Packaging | Individually wrapped in double-layer medical-grade PE/aluminum foil pouches, pyrogen-free, DNase/RNase-free options available |
Overview
The Otseins AF Series Microporous Filter Membranes are precision-engineered polymeric filtration media designed for critical separation tasks in life science research, biopharmaceutical manufacturing, and analytical sample preparation. These membranes operate on the principle of size-exclusion-based physical sieving, where particles larger than the nominal pore diameter are retained on the membrane surface or within its matrix while fluids and dissolved solutes pass through under applied pressure or vacuum. The AF Series leverages two chemically distinct base materials—Mixed Cellulose Ester (MCE) and Polyvinylidene Fluoride (PVDF)—to deliver broad chemical compatibility across aqueous, organic, and aggressive solvent systems. MCE membranes provide high flow rates and low extractables in water-based applications such as buffer sterilization and microbiological analysis, whereas PVDF variants offer exceptional mechanical strength, thermal stability up to 135°C, and resistance to strong acids, bases, and halogenated solvents—making them suitable for HPLC mobile phase filtration, cell culture supernatant clarification, and viral clearance validation studies.
Key Features
- Dimensional consistency: Precision die-cut membranes with tight tolerances (±0.15 mm) across standard diameters—13 mm, 25 mm, and 50 mm—for reliable fitment in syringe filters, vacuum filtration manifolds, and capsule filter housings.
- Controlled pore architecture: Nominal pore sizes of 0.18 µm, 0.22 µm (sterile-grade), 0.45 µm (clarification-grade), 0.8 µm, 1.2 µm, and 1.22 µm—each verified per ASTM F838-22 bacterial retention testing using Brevundimonas diminuta (ATCC 19146) challenge.
- Surface integrity: Smooth, symmetric morphology achieved via phase-inversion casting; low protein binding (<0.5 µg/cm² for IgG on hydrophilic PVDF) confirmed by ELISA-based assay.
- Regulatory-ready formats: Available in non-pyrogenic, DNase/RNase-free, and low-endotoxin (<0.25 EU/mL) configurations compliant with USP , , and ISO 13408-1 for aseptic processing environments.
- Manufacturing traceability: Each production lot carries full CoA (Certificate of Analysis) including bubble point test results, water flow rate (mL/min/cm² at 25°C, 1 bar), and heavy metal content (Pb, As, Cd, Hg) below ICH Q3D Class 3 limits.
Sample Compatibility & Compliance
The AF Series supports diverse sample matrices including cell lysates, serum-containing media, organic extracts (e.g., ethyl acetate, acetonitrile), and high-salinity buffers. Hydrophilic MCE membranes exhibit optimal performance in pH 4–8 aqueous solutions, while hydrophobic PVDF grades maintain structural integrity in pH 1–14 environments and tolerate >90% ethanol, isopropanol, and DMF. All variants conform to ISO 9001:2015 quality management standards and are manufactured in a cleanroom environment meeting ISO 14644-1 Class 7 specifications. Documentation packages include validation support files for GMP audits—including filter extractables profiling per USP , leachables screening (GC-MS/LC-MS), and compatibility data against common pharmaceutical excipients (e.g., polysorbate 80, mannitol, sodium chloride).
Software & Data Management
While membrane-based filtration is inherently hardware-agnostic, Otseins provides digital asset support for quality documentation integration. Customers receive encrypted PDF CoAs with embedded QR codes linking to raw test data (bubble point curves, flow rate logs, endotoxin assay reports) stored in a secure, time-stamped cloud repository compliant with FDA 21 CFR Part 11 requirements. Batch-level metadata—including lot number, manufacturing date, sterility method, and shelf-life expiration (24 months from date of manufacture when stored at 15–25°C, <60% RH)—is machine-readable and exportable to LIMS or MES platforms via CSV/JSON APIs.
Applications
- Sterile filtration of culture media, antibiotics, and injectable formulations (0.22 µm grade, ISO 13408-2 compliant).
- Clarification of fermentation broths and monoclonal antibody harvest streams prior to chromatography (0.45–1.2 µm grades).
- Particulate removal from HPLC and UHPLC mobile phases to prevent column clogging and detector fouling.
- Environmental microbiology: Enumeration of E. coli, Pseudomonas aeruginosa, and total viable counts in water samples (membrane filtration method per EPA Method 1603).
- Viral clearance studies: Pre-filtration conditioning step before nanofiltration units in bioprocess validation protocols (ICH Q5A R2).
FAQ
Are AF Series membranes certified for use in GMP manufacturing?
Yes—selected lots undergo full GMP-compliant manufacturing per ISO 13408-1 and carry CoQ (Certificate of Quality) with audit-ready documentation.
What is the maximum operating temperature for PVDF membranes?
Hydrophobic PVDF membranes withstand continuous operation up to 135°C; short-term autoclaving at 121°C for 20 minutes is validated for specific configurations.
Do you offer custom pore size or diameter options?
Custom diameters (e.g., 47 mm, 90 mm) and non-standard pore sizes (e.g., 0.1 µm, 5.0 µm) are available under OEM agreement with minimum order quantities and extended lead times.
How is bubble point testing performed and reported?
Each lot undergoes wet bubble point measurement per ASTM F316-22 using isopropanol; results are reported as mean ± SD (n ≥ 5) with 95% confidence intervals in the CoA.
Can these membranes be used for protein concentration via dead-end filtration?
No—AF Series membranes are designed for particulate and microorganism removal, not macromolecular concentration; ultrafiltration membranes with defined MWCO are recommended for that purpose.
