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安全信息

CGEP75TF3

Millipore

Millipore Express® SHF，小柱

cartridge nominal length 5 in. (12.5 cm), filter diam. 2.7 in. (6.9 cm), Code 7

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UNSPSC代码:
23151806

物料

polypropylene support
seal (Fluorocarbon rubber)

质量水平

400

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

EMPROVE® Filter
Millipore Express®

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

≤16.4 mL/min air diffusion at 2.75 bar (40 psig) (in water)
0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
1700 mbar max. differential pressure (25 psi) at 80 °C (Forward)
2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse)
340 mbar max. differential pressure (5 psi) at 135 °C (Forward)
6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)
7 bar max. inlet pressure (100 psi) at 25 °C (Forward)

技术

sterile filtration: suitable

长度

5 in.

宽度

2.7 in.

纯化柱标称长度

5 in. (12.5 cm)

过滤器直径

2.7 in. (6.9 cm)

filter filtration area

0.29 m2

过滤器尺寸

5 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® SHF

孔径

0.2 μm pore size

泡点

≥4000 mbar (58 psig), air with water

柱代码

Code 7

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相关类别

一般描述

Cartridge Type: Liquid
Device Configuration: Cartridge

包装

Double Easy-Open bag

制备说明

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C; 25 autoclave cycles of 60 min at 126 °C

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

TOC/Conductivity: After sterilization and a controlled water flush of 5.5 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

Directions for Use
  • 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

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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