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Cameroon Bioburden Control Filters LOPAC INNOVEX PF
Category:
Product Description
LOPAC INNOVEX PF Filters are made of hydrophilic polyethersulfone membrane (PES) with good hydrophilicity and low protein adsorption. They are suitable for the bacteria-reducing filtration of bioprocess fluids with easy adsorption and complex ingredient. They can reduce the microbial contamination level and meet the process requirements.
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
• Unique double layer design
• Reliable bacterial and particulate retention
• Excellent chemical compatibility (pH: 1-14)
• Less dissolution
• Low protein adsorption
Applications
• Decontamination of cell culture media
• Filtration of buffers
• Pre-column / Pre-ultrafiltration protection
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 | 0.8μm+0.45μm、1.2μm+0.45μm、0.45μm、0.22μm、0.45+0.22μm、0.65+0.22μm、0.8+0.22μm | 0.8μm+0.45μm、1.2μm+0.45μm、0.45μm、0.22μm、0.45+0.22μm、0.65+0.22μm、0.8+0.22μm | 0.8μm+0.45μm、1.2μm+0.45μm、0.45μm、0.22μm、0.45+0.22μm、0.65+0.22μm、0.8+0.22μm |
| 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 |
| Sterilization | Resistant to autoclaving and irradiation | Autoclave: 134°C30min25 times; Irradiation: <50 kGy | Autoclave: 134°C30min25 timesOnline steam sterilization: 134°C30min25 times (Δp≤0.3bar) |
| Component Material Toxicity | Meets USP<88> Class VI Biological Reactivity criteria | Meets USP<88> Class VI Biological Reactivity criteria | Meets USP<88> Class VI Biological Reactivity criteria |
| 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) |
| Integrity | 100% integrity tested before factory delivery | 100% integrity tested before factory delivery | 100% integrity tested before factory delivery |
| 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