PRODUCTS CENTER
Cameroon High Throughput Cartridge Filters PURIAGIS HC
Category:
Product Description
PURIAGIS HC high flux cartridge filters are made of polytetrafluoroethylene membrane (PTFE). They have natural hydrophobicity, excellent chemical compatibility and good temperature resistance. They are suitable for the decontamination and filtration of organic solvents.
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 |
|
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 |
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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 |
|
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
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Standard |
Description |
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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) |
Product Feature
• Highly controllable membrane size distribution and robust product performance
• Natural hydrophobic which is suitable for filtration of organic solvents
• High flux, high retention rate
Dimensions
| 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 (Single Layer) | 3.5cm² / 20cm² | S: 180cm²; 2.5": 0.073m²; 5": 0.23m²; 10": 0.63m² | φ63: 2.5":0.11/5":0.23/10":0.45/20":0.90/30":1.35m²φ70: 2.5":0.15/5":0.30/10":0.60/20":1.20/30":1.80m² |
| Filtration Area (Double Layer) | 3.5cm² / 20cm² | S: 160cm²; 2.5": 0.065m²; 5": 0.20m²; 10": 0.60m² | φ63: 2.5":0.11/5":0.23/10":0.45/20":0.90/30":1.35m²φ70: 2.5":0.15/5":0.30/10":0.60/20":1.20/30":1.80m² |
| Pore Size | 0.65+0.65μm | 0.65+0.65μm | 0.65+0.65μm |
| Materials of Construction | PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane | PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane | PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane |
| 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 (meets USP<85> requirements) | Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) | Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) |
| 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 |
Applications
• Organic solvent removal and filtration
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