PRODUCTS CENTER
Saudi Arabia Depth Filtration Card ZetaCARE
Category:
Product Description
Feature-Tec ZetaCARE Deep Card is composed of wood cellulose, inorganic filter aids, and charged resins through a multi-step composite process. The intricate three-dimensional porous structure within the filter medium efficiently removes insoluble contaminants such as particulates and cellular debris, along with certain soluble impurities, thereby providing robust assurance for high-efficiency liquid clarification.
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
- Filter media composed of wood fibers and inorganic filter aids
- Three-dimensional structure with progressively finer filtration layers.
- High throughput, high capacity, and high retention rate.
- Balanced pressure control ensures consistent precision across batches, enabling reliable operational processes.
- Available in both positively and negatively charged versions to meet diverse customer clarification needs.
Typical Applications
- Clarification filtration of fermentation broths or cell culture fluids
- Clarification filtration after virus inactivation
- Clarification filtration of blood and serum products
- Filtration of enzyme preparations
- Clarification filtration of plasmids or viruses
ZetaCARE DeepCard Series Compact Selection Table
| Parameter | Specification |
|---|---|
| Product Series | FCC, FCD, FZC, FZD, FGA, FGB |
| Filtration Layers | • FCC/FCD: Wood fibers + negative charge resin (FCD adds filter aids)• FZC/FZD: Wood fibers + positive charge resin (FZD adds filter aids)• FGA: Standard• FGB: High Flux |
| Dimensions (mm) | Φ47 (FCC/FCD/FZC/FZD); 400×400, 600×612 (FGA/FGB) |
| Max. Differential Pressure | Forward: 2.1bar @20°CReverse: 1.0bar @20°C |
| Regulatory Compliance | • Indirect food additives: FDA 21 CFR 177~182• Biocompatibility: USP <88> Class VI• Endotoxin: <0.25 EU/mL (USP <85> LAL test) |
| Post-Sterilization Performance (121°C/60min, 1 cycle) | • Conductivity: <20 μS/cm (after 50 L/m² purified water rinse)• TOC: <5 ppm (after 50 L/m² purified water rinse)• Non-volatile extractables: ≤4% of cardboard mass (after DI water soak & solvent extraction) |
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