Life Science Filter
Protecting Life with Biosecurity Filtration
Sterilizing High-Flux Hydrophilic Filter LOPAC BM
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LOPAC BM filter incorporates hydrophilic Polyethersulfone (PES) membrane with asymmetric pore structure. This feature enables efficient contaminant capture, resulting in a high dirt-holding capacity. LOPAC BM is suitable for sterilizing-grade filtration of process fluids and buffers, pre-column/ultra-filtration protection, and bioburden reduction of intermediate samples.
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
PDA TR No. 26
Establishes scientific correlation between integrity testing and bacterial retention performance
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
USP <85> / EP 2.6.14
Complies with bacterial endotoxin limits to support injectable product safety
ICH Q3D / USP <232>
Complies with elemental impurity control requirements
USP <788>
Complies with sub-visible particulate matter requirements for injectable quality
BPOG Protocol (2014)
Characterized per BPOG extractables protocol to support chemical compatibility assessment
3、Manufacturing Process & Batch Consistency
Standard
Description
ISO 11137 (VDmax)
Validated for gamma irradiation sterilization, achieving SAL 10⁻⁶ sterility assurance level
ICH Q1A (R2), Q1E
Validated through accelerated and long-term stability studies to support claimed shelf life
ISO 9001 / 13485
Certified to quality management systems, ensuring consistent product quality and full traceability
4、Process Operations & Performance
Standard
Description
USP <643> / <645>
Post-flush residuals comply with USP Water for Injection (WFI) quality requirements
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
GMO (EC) / BSE/TSE / BPA
Supporting declarations available: Non-GMO, BSE/TSE-Free, BPA-Free (where applicable)
Product Features
- High loading and throughput
- Excellent chemical compatibility (pH 1-14)
- Reliable retention of bacteria and particles
Typical Applications
- Buffer filtration, process fluids sterile filtration
- Pre-column/ultra-filtration protection
- Filtration of intermediate products
LOPAC BM PES 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 (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 Filter Aperture 0.22μm, 0.45μm+0.22μm 0.22μm, 0.45μm+0.22μm 0.22μm, 0.45μm+0.22μm Materials of Construction PP support/shell/end cap/fin/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane PP support/shell/end cap/fin/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane PP support/shell/end cap/fin/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 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> 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 <0.25 EU/mL (USP<85> compliant) <0.25 EU/mL (USP<85> compliant) <0.25 EU/mL (USP<85> compliant) Integrity 100% factory integrity tested 100% factory integrity tested 100% factory integrity tested Production Environment 100,000-class clean room 100,000-class clean room 100,000-class clean room -
Product Parameters
Typical Applications
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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