材料
polypropylene support
seal (Fluorocarbon rubber)
品質等級
法律遵循
meets FDA 21 CFR 177-182 (all component materials)
無菌
non-sterile
滅菌相容性
autoclavable compatible
steam-in-place compatible
產品線
Millipore Express®
特點
hydrophilic
with prefilter
製造商/商標名
Millipore Express®
參數
≤54.2 mL/min air diffusion at 3.45 bar (50 psig) (in water)
0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse)
0.35 bar max. differential pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psi) at 80 °C (Forward)
1000 mbar max. differential pressure (15 psi) at 135 °C (Forward)
1700 mbar max. differential pressure (25 psi) at 80 °C (Forward)
2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse)
2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse)
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
69 mbar max. differential pressure (<1.0 psi) at 135 °C (Reverse)
6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)
技術
sterile filtration: suitable
長度
20 in.
寬度
2.7 in.
柱標稱長度
20 in. (50 cm)
過濾器直徑
2.7 in. (6.9 cm)
過濾器尺寸
20 in.
過濾面積
0.96 m2
雜質
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基質
Millipore Express® SHR (w/Prefilter)
pore size
0.5/0.1 μm pore size
起泡點
≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
柱代碼
Code 7
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一般說明
包裝
準備報告
This product was manufactured with a MILLIPORE EXPRESS® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析報告
TOC/Conductivity: After sterilization and a controlled water flush of 40 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.
Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.
其他說明
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer wetting instructions of Filters with MILLIPORE EXPRESS® Membrane user guide
- Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
法律資訊
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