PRODUCTS CENTER
Product Description
he filter membrane needs to be used in conjunction with holders (or clamp holders) or funnels, etc.The filter membrane, which has been optimized through processes, meets the requirements of biological, pharmaceutical and sterilization filtration, and features excellent flow rate and extremely high filtration capacity. It can filter quickly, has a low protein binding rate, and is compatible with various drugs, making it suitable for clinical applications. When filtering a unit volume of sample, the frequency of filter replacement is relatively low, thus saving time and cost.
Advanced Bio-Pharma Filtration Solutions
Enhance yield and ensure compliance with Feature-Tec’s precision-engineered filtration technologies.
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Targeted Applications: mAb Production, Vaccine Processing, ADC Manufacturing, & Fermentation.
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Core Technologies: Depth Filtration, Bioburden Reduction, & Automatic Integrity Testing.
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Expert Services: Full Process Validation & Technical Support.
International Standards & Regulatory Compliance
Feature-Tec Sterilizing-Grade Filter Certifications & Compliance
1、Core Function & Definition (Sterilizing-Grade Identity)
|
Standard |
Description |
|
ASTM F838 |
Validated to the internationally recognized "gold standard" for bacterial retention in sterilizing-grade filters |
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PDA TR No. 26 |
Establishes scientific correlation between integrity testing and bacterial retention performance |
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21 CFR 211.65 |
Compliant with FDA requirements for material safety of pharmaceutical manufacturing equipment |
2、Biosafety & Patient Safety
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Standard |
Description |
|
USP <88> / ISO 10993 |
Validated for biocompatibility per USP Class VI and ISO 10993 requirements |
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USP <85> / EP 2.6.14 |
Complies with bacterial endotoxin limits to support injectable product safety |
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ICH Q3D / USP <232> |
Complies with elemental impurity control requirements |
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USP <788> |
Complies with sub-visible particulate matter requirements for injectable quality |
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BPOG Protocol (2014) |
Characterized per BPOG extractables protocol to support chemical compatibility assessment |
3、Manufacturing Process & Batch Consistency
|
Standard |
Description |
|
ISO 11137 (VDmax) |
Validated for gamma irradiation sterilization, achieving SAL 10⁻⁶ sterility assurance level |
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ICH Q1A (R2), Q1E |
Validated through accelerated and long-term stability studies to support claimed shelf life |
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ISO 9001 / 13485 |
Certified to quality management systems, ensuring consistent product quality and full traceability |
4、Process Operations & Performance
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Standard |
Description |
|
USP <643> / <645> |
Post-flush residuals comply with USP Water for Injection (WFI) quality requirements |
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ISTA 2A / ASTM F2096 |
Validated for packaging integrity to maintain sterile barrier during transportation |
5、Regulatory & Supply Chain Compliance Statements
|
Standard |
Description |
|
21 CFR 177-182 |
Materials comply with FDA requirements for indirect food-contact materials |
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GMO (EC) / BSE/TSE / BPA |
Supporting declarations available: Non-GMO, BSE/TSE-Free, BPA-Free (where applicable) |
Aqueous filter membrane
| Material Type | Product Description |
|---|---|
| Hydrophilic PES | Optimized polyethersulfone membrane. The loose and porous internal structure results in fast filtration speed and high flux. It has excellent solvent compatibility and can tolerate pH levels ranging from 1 to 14. It can be sterilized at 121 °C or 134 °C. Two specifications are available: 0.22 μm and 0.45 μm. |
| Hydrophilic PVDF | Excellent chemical compatibility, widely used for filtering protein and biological products, offering two specifications: 0.22 μm and 0.45 μm. |
| Hydrophilic PTFE | Naturally hydrophobic, based on it, modified into hydrophilic filter membrane, excellent chemical compatibility, almost resistant to all organic solvents. |
Organic solvent filter membrane
| Material Type | Product Description |
|---|---|
| Hydrophobic PTFE | Natural hydrophobic, excellent chemical compatibility, and almost tolerance to all organic solvents. |
Air/Gas filter membrane
| Material Type | Product Description |
|---|---|
| Hydrophobic PTFE | The hydrophobic performance is stable and it is suitable for air and gas filtration. It is not affected by air humidity. |
| Glass fiber | Pure glass fiber, suitable for high-temperature gas emission monitoring, trace metal analysis in gravimetric analysis experiments, as well as PFAS testing, etc. |
Contact
Hotline: (+86)400-820-6150
Email: marketing@feature-tec.com
Address: 8/F, Block A, Building 3, Tianhua Information Technology Park, 299 Longcao Road, Xuhui District, Shanghai