Life Science Filter
Protecting Life with Biosecurity Filtration
High Capacity Clarification Filters PolyCARE
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Feature-Tec PolyCARE High Capacity Clarification Filters are recommerded for the pretreatment in the biopharmaceutical industry, such as clarification of fermentation broth, removal of cellular debris and DNA etc. It can minimize the difficulty of downstream purification.
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)
Feature
• Wide range of appliction in a variety of pore sizes
• Compatible with organic solvents and water-soluble liquid
• Acids and alklis resistance, PH 1-14
• High dirt-holding capacity, not easily clogged
Applications
• Clarification and filtration for fermentation
• Filtration of organic solvent by impurities removal and decarburization
• Clarification and filtration of process waterDimensions
PolyCARE Filter Series Compact Selection Table
Parameter Disc Filters Capsule Filters Cartridge Filters Nominal Size (in) / S / 2.5" / 5" / 10" 2.5" / 5" / 10" / 20" / 30" (φ63/φ70) Filtration Area (m²) 3.5cm² / 20cm² S: 150cm²; 2.5": 0.056m²; 5": 0.18m²; 10": 0.48m² φ63: 2.5":0.10/5":0.20/10":0.38/20":0.76/30":1.14m²φ70: 2.5":0.15/5":0.30/10":0.51/20":1.02/30":1.53m² Pore Size 0.1μm, 0.22μm, 0.45μm, 0.65μm, 1.0μm, 3.0μm, 10μm, 25μm, 40μm, 70μm 0.1μm, 0.22μm, 0.45μm, 0.65μm, 1.0μm, 3.0μm, 10μm, 25μm, 40μm, 70μm 0.1μm, 0.22μm, 0.45μm, 0.65μm, 1.0μm, 3.0μm, 10μm, 25μm, 40μm, 70μm Materials of Construction PP support/end cap; PP/222/226 metal reinforcement adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PP filtration layer PP support/end cap; PP/222/226 metal reinforcement adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PP filtration layer PP support/end cap; PP/222/226 metal reinforcement adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PP filtration layer Max Forward ΔP 5bar (72.5psi) @20°C L/M: 5bar@20°C / 3bar@50°CS: 4bar@20°C / 2bar@50°C 5bar@20°C / 2bar@80°C Max Reverse ΔP 2bar (29psi) @20°C 2bar@20°C / 1.5bar@50°C 2bar (29psi) @20°C Component Material Toxicity Meets USP<88> Biological Reactivity for Class VI Meets USP<88> Biological Reactivity for Class VI Meets USP<88> Biological Reactivity for Class VI Bacterial Endotoxin Aqueous extraction <0.25 EU/mL (USP<85> compliant) Aqueous extraction <0.25 EU/mL (USP<85> compliant) Aqueous extraction <0.25 EU/mL (USP<85> compliant) Cleanness Complies with FDA 21 CFR 211.72/210.3(b)(5)(6) & USP<788> Complies with FDA 21 CFR 211.72/210.3(b)(5)(6) & USP<788> Complies with FDA 21 CFR 211.72/210.3(b)(5)(6) & USP<788> Ingredient Material Toxicity Meets USP<88> Class VI plastics reaction test standards Meets USP<88> Class VI plastics reaction test standards Meets USP<88> Class VI plastics reaction test standards Production Environment 100,000-class clean room 100,000-class clean room 100,000-class clean room -
Product Parameters
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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