PTFE filter cartridge - FDA/EU Pharmacopoeia
Filter Material
Polytetrafluoroethylene (PTFE)
Features and Advantages
High Pressure Resistance
High Temperature Resistance
Strong Anti-pollution Ability
High Throughput
Application Areas
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Product Details
Application
• Process gas sterilization filtration
• Tank breather
Characteristics and Advantages
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Global Regulatory Compliance |
Compliant with USP<87>, USP<88> |
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Optimized product structure and design |
Faster flow rate and lower pressure drop |
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Multiple interface types and length options |
Suitable for most current stainless steel filters |
Technical Specifications
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Accuracy |
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0.22μm |
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Material Composition |
Membrane |
Polytetrafluoroethylene (PTFE) |
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Support Layer |
Polypropylene (PP) |
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Housing/Center Rod/End Caps |
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O-ring |
Silicone Rubber |
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Welding |
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Hot melt welding |
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Effective Area |
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≥ 0.58m2@ 10” filter, ≥ 0.28m2 @ 5” filter |
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Minimum bubble point, 60% IPA, 25°C ≥1155mbar |
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Minimum bubble point, 95% ethanol, 25°C ≥1100mbar |
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10” filter ≤1.4mL/min |
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Operating Conditions |
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Maximum forward operating pressure difference 4.2bar@25°C，2.0bar@80°C |
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Recommended Sterilization Cycles |
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The filter integrity remains intact after the following sterilization cycles: 100 times forward 135°C, 30 minutes online steam sterilization; Or 50 times reverse 127°C, 30 minutes online steam sterilization; or 100 times 127°C, 30min offline sterilization |
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Endotoxin Release |
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LAL method test, <0.25EU/mL |
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TOC |
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After rinsing with 5L purified water per 10” filter, TOC<0.5mg/L |
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Conductivity |
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After rinsing with 5L purified water per 10” filter, conductivity <1.3 μS/cm |
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Particle Release |
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Meets USP requirements for particulate matter in water for injection |
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No Fiber Shedding |
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Meets the requirements for fiber-free filters as defined in 21 CFR 210.3(b)(6) |
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Extractables |
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Sterilized filter, extracted by 50% ethanol aqueous solution shaking for 24h (contact Entegris for details) |
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Biocompatibility |
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The product passed USP<87> test, and all constituent materials meet USP Class VI plastic standards |
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Bacterial Retention Test |
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According to ASTM F-838, passed the challenge test with defective short-wave single-celled bacteria (ATCC 19146) |
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Indirect Food Additives |
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Meets FDA indirect food additive requirements 21CFR 177 |
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Food Contact Materials |
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Meets the requirements of EU Framework Directive (EU) No.1934/2004 |
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Quality System |
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Product manufacturing process complies with ISO13485 and ISO9001 quality management system requirements |
Water intrusion, 2620mbar, 25°C 5” filter ≤1.0mL/min
Pressure Drop Flow Rate Curve
Ordering Information
Please contact us for details
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Email: service@hz-hx.cn
Keywords
PTFE filter cartridge - FDA/EU Pharmacopoeia
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