PRODUCTS CENTER
Cameroon Sterilizing Filters LOPAC INNOVEX SP
Category:
Product Description
LOPAC INNOVEX SP series filters are made of modified polyethersulfone membrane (PES) with good hydrophilicity and low protein adsorption. They are suitable for sterilizing filtration of process fluid, buffer and column protection.
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 |
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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 Feature
• Reliable bacterial retention
• Excellent chemical compatibility (pH 1-14)
• Unique double layer membrane design for increased loading capacity
• Rugged construction for multiple sterilization cycles
Applications
• Sterilization filtration of cell culture media
• Buffer filtration
• Pre-Column / Pre-Ultrafiltration Protective Filtration
• Sterilization Filtration of end products
Dimensions
| Parameter | Disc Filters | Capsule Filters | Cartridge Filters |
|---|---|---|---|
| Nominal Size (inches) | / | S / 2.5" / 5" / 10" | 2.5" / 5" / 10" / 20" / 30" (φ63 / φ70) |
| Filtration Area (Single Layer) | 3.5cm² / 20cm² | S: 180cm²2.5": 0.073m²5": 0.23m²10": 0.63m² | φ63: 2.5":0.11m² / 5":0.23m² / 10":0.45m² / 20":0.90m² / 30":1.35m²φ70: 2.5":0.15m² / 5":0.30m² / 10":0.60m² / 20":1.20m² / 30":1.80m² |
| Filtration Area (Double Layer) | 3.5cm² / 20cm² | S: 160cm²2.5": 0.065m²5": 0.20m²10": 0.60m² | φ63: 2.5":0.11m² / 5":0.23m² / 10":0.45m² / 20":0.90m² / 30":1.35m²φ70: 2.5":0.15m² / 5":0.30m² / 10":0.60m² / 20":1.20m² / 30":1.80m² |
| Pore Size | 0.22μm, 0.45μm+0.22μm | 0.22μm, 0.45μm+0.22μm | 0.22μm, 0.45μm+0.22μm |
| Materials of Construction | Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES | Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES | Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES |
| Max Forward Differential Pressure | 5bar (72.5psi) @20°C | L/M: 5bar (72.5psi) @20°C / 3bar (43.5psi) @50°CS: 4bar (58psi) @20°C | 5bar (72.5psi) @20°C / 2bar (29psi) @80°C |
| Max Reverse Differential Pressure | 2bar (29psi) @20°C | 2bar (29psi) @20°C / 1.5bar (22psi) @50°C | 2bar (29psi) @20°C |
| Sterilization | Resistant to autoclaving and irradiation | Autoclave: 134°C30min25 timesElectron beam irradiation: <50 kGy | Autoclave: 134°C30min25 timesOnline steam sterilization: 134°C30min25 times (Δp≤0.3bar) |
| Bacterial Interception | >10⁷cfu / cm² B.diminuta (ATCC 19146) | >10⁷cfu / cm² B.diminuta (ATCC 19146) | >10⁷cfu / cm² B.diminuta (ATCC 19146) |
| 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 (meets USP<85> requirements) | Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) | Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) |
| 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