PES filter cartridge - FDA/EU Pharmacopoeia
Filter Material
Polyethersulfone (PES)
Features and Advantages
High Pressure Resistance
High Temperature Resistance
Strong Anti-pollution Ability
High Throughput
Application Areas
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Product Details
Application
• Biopharmaceutical
- Microbial limit control filtration and sterile filtration for injectables, etc.
- Sterile filtration of solvents, buffers, etc.
- Sterile filtration of process water
• Food and beverage
- Plant water
- Bottled water
- Soft drinks, etc.
Characteristics and advantages
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Global regulatory compliance |
The product has passed the USP <87> test, and all constituent materials meet the requirements of USP Class VI plastics standards. |
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A variety of interface types and lengths are available. |
Suitable for most current stainless steel filters, matching different process applications. |
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Optimized product structure and design |
Faster flow rate and lower pressure drop, reducing usage costs. |
Technical Specifications
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Accuracy |
0.22, 0.45 µm |
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Material Composition |
Membrane Polyethersulfone (PES) |
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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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Welding |
Hot melt welding |
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Effective area |
≥0.6 m2/10” cartridge |
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Integrity test (0.22 μm) |
Minimum bubble point 25°C (77°F) ≥3500 mbar |
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10” filter ≤30 mL/min |
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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 cycles |
20 online steam sterilizations or offline sterilizations, 127°C (261°F), 30 minutes |
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Endotoxin release |
LAL method test, <0.25 EU/mL |
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TOC |
After rinsing each 10” filter with 11L of purified water, TOC <0.5 mg/L |
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Conductivity |
After rinsing each 10” filter with 11L of purified water, conductivity <1.3 µS/cm |
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Particle release |
Meets the particulate matter requirements for water for injection as specified in the USP. |
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Extractables |
After sterilization of the filter, extraction with 50% ethanol aqueous solution by shaking for 24h (please contact Entegris andAnow for details) |
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Biosafety |
The product passed the USP<87> test, and all constituent materials meet the requirements of USP Class VI plastics standards. |
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Bacterial Retention Test |
According to ASTM F-838, it passed the challenge test with defective short-wave single-celled bacteria (ATCC 19146), (0.22 µm) |
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Indirect Food Additives |
Meets FDA indirect food additive requirements 21CFR 177-182 |
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Food Contact Material |
Meets the requirements of EU Framework Directive (EU) No. 1934/2004 |
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Quality System |
The product manufacturing process complies with ISO13485 and ISO9001 quality management system requirements. |
Maximum diffusion flow (2800 mbar, 25°C (77°F)) 5” filter ≤15 mL/min
Differential Pressure Flow Rate Curve
Ordering Information
Please contact us for details
Email: seller@hz-hx.cn
Email: service@hz-hx.cn
Interface Diagram
Keywords
PES filter cartridge - FDA/EU Pharmacopoeia
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