Life Science Filter
Protecting Life with Biosecurity Filtration
Sterilizing Filters LOPAC INNOVEX SP
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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.
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 productsDimensions
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
Product Parameters
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Filter Type
dish filter
capsule filter
Cartridge filter
Nominal Size (inches)
φ50mm
S
2.5
5
10
Specifications
5
10
20
30
Filtration area
(M²)single layer
15cm ²
180cm ²
0.073
0.23
0.63
D63
D700.23
0.30.45
0.60.9
1.21.35
1.8double layer
15cm ²
160cm ²
0.065
0.2
0.6
D63
D700.23
0.30.45
0.60.9
1.21.35
1.8filter pore size
0.22μm
Structure material
Support layer: Polypropylene (PP)
Housing/End caps/Fins: Polypropylene (PP)
Interface: Polypropylene (PP),222/226 with built-in stainless steel reinforcement option
Sealing ring: silicone rubber/EPDM/fluorine rubber/fluorine rubber
Hot melt technology: hot melt sealing without adhesive
Membrane material: hydrophilic polyethersulfone (PES)Maximum operating differential pressure
Forward
2bar(29psi)@ 20 ℃
L 、 M:5bar(72.5psi)@ 20℃
3bar(43.5psi)@50℃5bar(72.5psi)@25℃
2bar(29psi)@ 80 ℃S:4bar(58psi)@20℃
Reverse
2bar(29psi)@ 20 ℃
2bar(29psi)@ 20 ℃
1.5bar(22psi)@50℃2bar(29psi)@ 25°C
Sterilization method
Withstand high pressure steam sterilization
and radiation-resistant sterilizationHigh pressure steam sterilization: 134°C * 30min * 25 times
Irradiation sterilization:<50 kGyHigh pressure steam sterilization: 134°C * 30min * 25 times
Online steam sterilization: 134 ℃ * 30min * 25 times (△p≤ 0.3bar)bacterial interception
> 10cfu/cm2. B.diminuta (ATCC19146)
biological safety
The structural components of this filter element meet the current USP<88> grade VI material biosafety requirements
Cleanliness
Meet the requirements of FDA21CFR211.72 and 210.3 (B)(5)(6) for non-fiber shedding filters, and the level of insoluble particles in the flushing fluid meets the requirements of USP<788>
Toxicity of ingredients and materials
Comply with USP<88> Response Test for Class V Plastics
endotoxin
The endotoxin level of the filter element flushing fluid tested by gel method <0.25EU/mL meets the requirements of USP<85>
integrity
100% of each cartridge/filter passed the integrity test before leaving the factory
Production Environment
All in one hundred thousand clean workshop production
Typical Applications
Related components
Related Equipment
Message consultation
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
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