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vatican Centrifugal Filter Device Featain
Category:
Product Description
The Featain centrifugal filter device provide rapid ultrafiltration, making it easy to concentrated substances from diluted and complex sample. The ultrafiltration membranes enable rapid sample processing with high recovery, achieving concentration capabilities of up of tens times. It can reduce solute polarization and membrane contamination. Generally, the sample processing time is a few minutes or several tens of minutes, depending on the sample conditions (related to the molecular weight cutoff). The concentrate can be collected using a pipette, while the ultrafiltrates is collected in the provided centrifuge tubes.
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)
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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 |
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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
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Standard |
Description |
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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 |
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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
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Standard |
Description |
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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) |
Product Features
- Lid, filter, and centrifuge tube assembly
- PES ultrafiltration membrane
- Ultra-fast rotation time
- Translucent shell and volume scale for easy sample monitoring
- Low protein adsorption
Typical Applications
- Concentration and separation of biological samples such as antigens, antibodies, enzymes, nucleic acids, or microorganisms
- Purification of macromolecular components in culture media extraction solutions and cell lysates
- Diluted or pre-purified proteins in the elution buffer of concentration columns
- Desalting, buffer exchange, and protein dialysis
Parameters
| Parameter | Centrifugal Filter Device |
|---|---|
| Specification | 15mL |
| MWCO | 3kD, 10kD, 30kD, 50kD, 100kD |
| Construction | Tubing Material: PPCap Material: PEMembrane: PES |
| Biosafety | Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI |
| Clealiness | Comply with FDA 21 CFR 211.72 and 210.3(b)(5)(6) for no fiber release filters, and USP <788> for insoluble particulate levels in the flush water |
| Material Toxicity | Component materials meet USP <88> Class VI plastics biological reactivity standards |
| Endotoxin | <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
| Manufacture Environment | Manufactured in the 100,000 class clean room |
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