PES 0.45μm Cartridge Filters
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• High flow rate, high capacity.
• Valicated bioburden reduction.
• Stable performance, Withstand multiple.
• Cycles of sterilization.
• Broad chemical compatibility.
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• Pre-fltration for buffers
• Cell culture media
• Pre-filtration for column protection
• Pre-filtration before terminal sterilization, etc
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Product Specifications
Product Specifications
5 inch
10 inch
20 inch
30 inch
Diameter
Maximum Length69 mm
150 mm69 mm
320 mm69 mm
560 mm69 mm
800 mmMaterials of
Construction
Membrane
Hydrophilic polyethersulfone (PES)
Supporting Layer
Polypropylene (PP)
O-rings
Silicone、Ethylene propylene diene monomer(EPDM)
Core/Cage/End caps/Housing
Polypropylene (PP)
Working characteristics
Maximum Differential
Pressure
Forward: 5.0 bar(72.5 psi)@ 25°C/3.0 bar(43.5 psi)@ 80°C
Reverse: 2.0 bar(29.0 psi)@ 25°C
Sterilization
Resistance
In-line steam: 135℃, 30 min,10 cycles
Autoclave: 135℃, 30 min, 10 cycles
Filtration Area
0.32 m2
0.65 m2
1.3 m2
1.95 m2
Pore Size
0.45 μm
Biological Safety
All construction components meet the biological safety requirements refering to USP<88> Class VI plastic and USP<87>
Indirect Food Additive
All component materials meet the requirements of Indirect Food Additive cited in EU 1935/2004/EC and FDA 21 CFR 177-182
Cleanliness
Meets the requirements for a ‘non-fiber releasing’ filter defined in FDA 21 CFR 211.72 and 210.3 (b) (5) (6), and particulate matter meets the requirements of USP<788>
Endotoxin
Endotoxin﹤0.25 EU/mL by LAL test method, which complies with the requirements of USP<85>
TOC/Conductivity
TOC﹤0.5 mg/L, Conductivity﹤1.3 μS/cm
Manufacturing Integrity
100% integrity test passed
Manufacturing Environment
Manufactured in conformance with cGMP
Test Results of Flow Differential Pressure
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