PP filter cartridge - FDA/EU Pharmacopoeia
Filter Material
Polypropylene (PP)
Features and Advantages
High Pressure Resistance
High Temperature Resistance
Strong Anti-pollution Ability
High Throughput
Application Areas
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Product Details
Applications
· Biopharmaceutical
– Purified water security filtration
– Prefiltration of injections, etc.
– Particle removal filtration of buffer solutions, etc.
· Food and beverage
– Plant water
– Bottled water
– Soft drinks, etc.
Characteristics and advantages
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Made of polypropylene materials and components |
Good chemical compatibility, suitable for most application points in the biopharmaceutical and food and beverage industries |
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Optimized structural design |
Provides faster flow rates and lower pressure drops, reducing costs |
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The product meets USP 87 and 88 |
Provides excellent biosafety assurance and global regulations |
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Regulatory requirements |
Compliance |
Technical specifications
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Accuracy |
0.1, 0.2, 0.45, 1.0, 3.0, 5.0, 10, 20 µm |
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Material |
Filter material Polypropylene (PP) |
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Support layer Polypropylene (PP) |
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Housing/center rod/end plate Polypropylene (PP) |
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O-ring Silicone rubber |
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Gasket (Code F) Silicone rubber |
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Welding |
Hot melt welding |
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Effective area |
≥0.43 m2/10” |
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Operating conditions |
Maximum forward operating pressure difference: 4.2 bar @ 25°C (77°F), 2.0 bar @ 80°C (176°F) |
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Maximum operating temperature: 80°C (176°F) |
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Recommended sterilization times |
20 online steam sterilizations or offline sterilizations, 127°C (261°F), 30 minutes |
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Endotoxin release |
Gel test, <0.25 EU/mL |
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TOC |
<0.5mg/L after rinsing each 10” filter with 11L purified water |
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Conductivity |
<1.3 µS/cm after rinsing each 10” filter with 11L purified water |
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Particle release |
Meets USP requirements for particulate matter in water for injection |
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Extractables |
Sterilized filter, extracted with 50% ethanol water by easy shaking for 24h (contact Entegris for details) |
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Biosafety |
The product has passed the USP<87> test, and all constituent materials meet the requirements of USP Class VI plastics. |
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Quality system |
The product manufacturing process conforms to the requirements of the ISO13485 and ISO9001 quality management systems |
Differential pressure flow rate curve
Ordering information
Please contact us for details
Email: seller@hz-hx.cn
Email: service@hz-hx.cn
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