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Merck
CN
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文件

CV0672TP3

Millipore

Durapore 多介质筒式过滤器 20 in.0.5+0.22 µm 7 号

pore size 0.5/0.22 μm, cartridge nominal length 20 in. (50 cm), Code 7 (2-226; O-rings w/locking-tabs)

别名:

多介质 Durapore® 0.5/0.22 µm，筒式

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About This Item

UNSPSC代码:
23151806
eCl@ss:
27293007

物料

PVDF
mixed cellulose esters (MCE)
mixed cellulose esters (MCE) prefilter
polypropylene
polypropylene support
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

Durapore®

特点

hydrophilic

制造商/商品名称

Durapore®

参数

≤26.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse; Intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 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)

直径

6.9 cm (2.7 in.)

过滤面积

1.38 m2

杂质

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

重量萃取物

≤90 mg/cartridge

基质

Multimedia Durapore®

pore size

0.5/0.22 μm pore size

输入

sample type liquid

泡点

≥3450 mbar (50 psig), air with water at 23 °C

柱代码

Code 7 (2-226; O-rings w/locking-tabs)

相关类别

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 for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
6 autoclave or SIP cycles of 30 min @ 123 °C
This product was manufactured with a Durapore® 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 were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥10 L

法律信息

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

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储存分类代码

11 - Combustible Solids

WGK

WGK 2

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