物料
polypropylene support
seal (Fluorocarbon rubber)
质量水平
管理合规性
meets FDA 21 CFR 177-182 (all component materials)
无菌性
non-sterile
灭菌适用性
autoclavable compatible
steam-in-place compatible
产品线
Millipore Express®
特点
hydrophilic
制造商/商品名称
Millipore Express®
参数
≤66.6 mL/min air diffusion at 3.45 bar (50 psig) (in water)
0.35 bar max. differential pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psi) at 80 °C (Forward)
1700 mbar max. differential pressure (25 psi) at 80 °C (Forward)
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse)
340 mbar max. differential pressure (5 psi) at 135 °C (Forward)
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)
技术
sterile filtration: suitable
长度
20 in.
宽度
2.7 in.
纯化柱标称长度
20 in. (50 cm)
过滤器直径
2.7 in. (6.9 cm)
过滤器过滤面积
1.2 m2
过滤器尺寸
20 in.
杂质
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质
Millipore Express® SHR
孔径
0.1 μm pore size
泡点
≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
柱代码
Code 7
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一般描述
包装
制备说明
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).
分析说明
TOC/Conductivity: After sterilization and a controlled water flush of 20 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.
其他说明
- 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
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