PRODUCTS CENTER
Russia High Capacity Clarification Filters PolyCARE
Category:
Product Description
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 |
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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
|
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 |
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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
|
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) |
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 water
Dimensions
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 |
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