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COA分析证书/COQ

CPGE71TP

Millipore Express^® PHF，小柱

Name: Millipore Express<SUP>®</SUP> PHF，小柱
Brand: MM

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal

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别名:

Millipore Express^® PHF Cartridge Filter 10 in. 0.2 µm Code 7 Silicone

UNSPSC代码:

23151806

eCl@ss:

32031690

物料

polyethersulfone
polypropylene
polypropylene support
polysulfone
silicone seal

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
steam-in-place compatible

产品线

Millipore Express^®

特点

hydrophilic

制造商/商品名称

Millipore Express^®

参数

≤30 mL/min air diffusion at 2.76 bar (40 psig) and 23 °C (in water)
0.07 bar max. differential pressure (1 psid) at 135 °C (Reverse)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
1.0 psi max. differential pressure (69 mbar) at 135 °C (Reverse)
1.4 bar max. differential pressure (20 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
20 psi max. differential pressure (1.4 bar) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 80 °C (Forward)
5.0 psi max. differential pressure (340 mbar) at 135 °C (Forward)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

技术

bioburden reduction: suitable

长度

10 in.

宽度

2.7 in.

纯化柱标称长度

10 in. (25 cm)

直径

6.9 cm (2.7 in.)

过滤面积

0.54 m²

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^® PHF

孔径

0.2 μm pore size

输入

sample type liquid

柱代码

Code 7

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一般描述

Device Configuration: Cartridge

包装

Double Easy-Open bag

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 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.

制备说明

Sterilization Method
12 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 15 autoclave cycles of 60 min @ 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

Bacterial Retention
Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

TOC/Conductivity
After sterilization and a controlled water flush of 10 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

法律信息

ASTM is a registered trademark of American Society for Testing and Materials

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

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Millipore Express® PHF，小柱