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Brand Name : | OEM, ANOW |
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Product description
Membrane | Hydrophilic PES |
Color | White |
Filter Surface | Plain |
Thickness, μm | 110~140 |
Diameter | Φ47, Φ60, Φ90, Φ142, Φ150, Φ200, Φ250, Φ293, Φ300 |
Pore Size, μm | 0.1, 0.22, 0.45, 0.65, 0.8, 1.2, 3.0 |
Maximum Operating Pressure | Forward: 4.2 bar @ 23 °C; 1.5 bar @ 85 °C |
pH | 1~14 |
Flow Rate | |
0.22 μm | ≥ 15 mL/min/cm2 at 1 bar |
0.45 μm | ≥ 35 mL/min/cm2 at 1 bar |
Integrity Test-water bubble point at 23 °C | |
0.22 μm | ≥ 3500 mbar |
0.45 μm | ≥ 2500 mbar |
Bacterial Retention | |
Passed the bacterial challenge testing using Brevundimonas diminuta(ATCC19146)(0.22 μm) / Serratia marcescens (ATCC14041)(0.45 μm) at a minimum challenge concentration of 1 x 107 CFU/cm2. | |
Extractables | |
< 0.5% | |
Effluent Particle Level | |
Meets the requirements of Chinese Pharmacopoeia 2010, Volume Ⅱ, appendix IX C. | |
Non-Fiber Releasing | |
Meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |
Biological Safety | |
Component materials meet the requirements of USP <88> Biological Reactivity Tests for Class VI Plastics. | |
TOC | |
< 500 ppb | |
Sterilization | |
By autoclave at 123°C or EO | |
Oxidizable Substances | |
Meets the criteria of Chinese Pharmacopoeia 2010, volume Ⅱ for purified water. | |
Bacterial Endotoxins | |
< 0.5 EU/ml as determined by the LAL test | |
Good Manufacturing Practices | |
Manufactured in an ANOW facility which adheres to Good Manufacturing Practices. |
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