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SVEPA25NB6

Millipore Express^® SHR, OptiScale^® Capsule

Name: Millipore Express<SUP>®</SUP> SHR, OptiScale<SUP>®</SUP> Capsule
Brand: MM

filtration area 3.5 cm², OptiScale^® 25

别名:

Millipore Express SHR Optiscale25mm 0.1 μm NB

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About This Item

UNSPSC代码:

23151806

eCl@ss:

32031690

NACRES:

NB.24

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物料

polyethersulfone membrane
polypropylene
polypropylene support
polypropylene vent cap

质量水平

400

管理合规性

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

无菌性

non-sterile

灭菌适用性

autoclavable compatible

产品线

OptiScale^® 25

特点

hydrophilic

制造商/商品名称

Millipore Express^®

参数

4.1 bar max. inlet pressure (60 psi) at 25 °C
60 psi max. differential pressure (4.1 bar) at 25 °C (forward)

技术

sterile filtration: suitable

长度

3.9 cm (1.52 in.)

纯化柱标称长度

1.52 in. (39 mm)

直径

3.1 cm (1.2 in.)

过滤面积

3.5 cm²

杂质

≤0.25 EU/mL (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

配件

female Luer-Lok^® inlet connection
male Luer-Lok^® outlet connection
(Female Luer-Lok^® Inlet/Male Luer Slip Outlet)

运输

ambient

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一般描述

Device Configuration: 取样皿滤膜

其他说明

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

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 installation and wetting sections of OPTISCALE^®-25 user guide
Storage Statement: Please refer to OPTISCALE^®-25 user guide
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
1 autoclave cycle of 60 min @ 123 °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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

法律信息

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany

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主要文件

Millipore Express^® SHR, OptiScale^® Capsule