PRODUCTS CENTER
Saudi Arabia Depth Filter ZetaCARE
Category:
Product Description
Feature_Tec ZetaCARE depth filter boasts a stable, reliable, and powerful liquid clarification capability. The filter media is composed of wood cellulose, inorganic filter aids, and charged resins through a multi-step composite process.
The three-dimensional interwoven structure within the filter media effectively removes particles, cell debris, and other insoluble impurities, providing the first line of defense for efficient liquid clarification.
The uniformly distributed charges can effectively remove residual DNA and host cell proteins (HCP) and other soluble impurities, providing a second line of defense for efficient liquid clarification.
The dual overlapping protection ensures robust support for efficient liquid clarification, reducing the downstream purification load, helping customers shorten process times, lower production costs, and increase economic benefits.
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 |
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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
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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) |
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
| Feature | ZetaCARE Process Development (PD) | ZetaCARE Lab-Scale (LS) | ZetaCARE Production-Scale (PS) |
| Filtration Layer | Double Layer | Double Layer | Double Layer |
| Housing Material | PP | PP | Glass Fiber-Filled Polypropylene |
| Filter Sheet | Cellulose, Filter Aids, Resin | Cellulose, Filter Aids, Resin | Cellulose, Filter Aids, Resin |
| Support Layer | PP | PP | PP |
| O-Ring | / | / | Silicone |
| Effective Filtration Area | 23 $cm^2$ | 270 $cm^2$, 540 $cm^2$ | 0.11 $m^2$, 0.55 $m^2$, 1.1 $m^2$ |
| Dimensions (cm) | 8.9 $\times$ 6.6 $\times$ 4.1 | 22 $\times$ 14 $\times$ 7.9 / 9.4 | 61 $\times$ 33 $\times$ (2.94 / 7.4 / 12.4) |
| Outlet, Vent Ports | Luer Ports: Polycarbonate | 6mm Hose Barb | Flat Seal (TPE) |
| Max. Operating Pressure | 3.0 bar @ 20°C | 3.0 bar @ 20°C | 3.0 bar @ 20°C; 1.0 bar @ 80°C |
| Max. Forward D.P. | 2.1 bar @ 20°C | 2.1 bar @ 20°C | 2.1 bar @ 20°C; 1.0 bar @ 80°C |
| Max. Reverse D.P. | 1.0 bar @ 20°C | 2.1 bar @ 20°C | 2.1 bar @ 20°C |
| Sterilization Tolerance | Integrity remains unchanged after 2 cycles of 60 min @ 121°C | Integrity remains unchanged after 1 cycle of 60 min @ 121°C | Integrity remains unchanged after 1 cycle of 60 min @ 121°C |
| Indirect Food Additives | Complies with FDA standards (21 CFR 177-182) | Complies with FDA standards (21 CFR 177-182) | Complies with FDA standards (21 CFR 177-182) |
| Toxicity | Complies with USP <88> Class VI Biocompatibility tests | Complies with USP <88> Class VI Biocompatibility tests | Complies with USP <88> Class VI Biocompatibility tests |
| Bacterial Endotoxins | Filter Media: <0.25 EU/mL (USP <85> LAL method) | Filter Media: <0.25 EU/mL (USP <85> LAL method) | Filter Media: <0.25 EU/mL (USP <85> LAL method) |
| Conductivity | <20 μS/cm after rinsing with 100 L/$m^2$ purified water* | Same as PD | Same as PD |
| TOC | <5 ppm after rinsing with 100 L/$m^2$ purified water* | Same as PD | Same as PD |
| Non-volatile extractables | NVR levels ≤ 4% of cardboard's mass after standard extraction | Same as PD | Same as PD |
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