Life Science Filter
Protecting Life with Biosecurity Filtration
Depth Filtration Card ZetaCARE
-
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.
-
Targeted Applications: mAb Production, Vaccine Processing, ADC Manufacturing, & Fermentation.
-
Core Technologies: Depth Filtration, Bioburden Reduction, & Automatic Integrity Testing.
-
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)
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) -
Product Parameters
Typical Applications
Related components
Related Equipment
Message consultation
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