Life Science Filter
Protecting Life with Biosecurity Filtration
Depth Filter ZetaCARE
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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)
Standard
Description
ASTM F838
Validated to the internationally recognized "gold standard" for bacterial retention in sterilizing-grade filters
PDA TR No. 26
Establishes scientific correlation between integrity testing and bacterial retention performance
21 CFR 211.65
Compliant with FDA requirements for material safety of pharmaceutical manufacturing equipment
2、Biosafety & Patient Safety
Standard
Description
USP <88> / ISO 10993
Validated for biocompatibility per USP Class VI and ISO 10993 requirements
USP <85> / EP 2.6.14
Complies with bacterial endotoxin limits to support injectable product safety
ICH Q3D / USP <232>
Complies with elemental impurity control requirements
USP <788>
Complies with sub-visible particulate matter requirements for injectable quality
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
ICH Q1A (R2), Q1E
Validated through accelerated and long-term stability studies to support claimed shelf life
ISO 9001 / 13485
Certified to quality management systems, ensuring consistent product quality and full traceability
4、Process Operations & Performance
Standard
Description
USP <643> / <645>
Post-flush residuals comply with USP Water for Injection (WFI) quality requirements
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
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 virusesFeature 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 -
Product Parameters
Typical Applications
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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