PRODUCTS CENTER
Saudi Arabia High Capacity Clarification Filters GlasiCARE
Category:
Product Description
Feature-Tec GlasiCARE High-Capacity Liquid Clarification Filters use glass fiber as the filter media.They are suitable for pre-treatment of feed streams in the biopharmaceutical industry, including serum and blood products, fermentation broth, high-viscosity solutions. These filters can remove contaminants such as colloids, protein aggregates, and particles from the feed liquid, thereby increasing the capacity of downstream filters and reducing filtration costs.
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 |
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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 |
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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
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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 Features
- Using Glass Fiber as filter medium
- High dirt-holding capacity and high retention rate
- Fixed pore structure, low pressure difference, long service life
Typical Applications
- Clarification filtration of serum and blood products
- Clarification filtration of fermentation broth and cell culture fluids
- Clarification filtration of high-viscosity solutions
GlasiCARE Glass Fiber 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: 100cm²; 2.5": 0.028m²; 5": 0.09m²; 10": 0.24m² | φ63: 2.5":0.07/5":0.13/10":0.27/20":0.53/30":0.80m²φ70: 2.5":0.10/5":0.20/10":0.40/20":0.80/30":1.20m² |
| Pore Size | 1.2 μm | 1.2 μm | 1.2 μm |
| Materials of Construction | PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; Glass fiber filtration layer | PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; Glass fiber filtration layer | PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; Glass fiber filtration layer |
| Max Forward ΔP | 3bar (43.5psi) @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 | 1bar (14.5psi) @20°C | 2bar@20°C / 1.5bar@50°C | 2bar (29psi) @20°C |
| Sterilization | Resistant to autoclaving and irradiation | Autoclave: 134°C30min1 time; Irradiation: <50 kGy | Autoclave: 134°C30min1 timeOnline steam sterilization: 134°C30min1 time (Δp≤0.3bar) |
| 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 |
| 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 |
| 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) |
| 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