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Merck
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安全信息

CV0602TP3

Millipore

多介质 Durapore® 0.5/0.22 µm，筒式

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 0

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About This Item

UNSPSC代码:
23151806

物料

mixed cellulose esters (MCE) prefilter
polypropylene device
polypropylene support
silicone seal

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

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) (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 temp. (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)

device size

20 in.

过滤器直径

2.7 in. (6.9 cm)

filter filtration area

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

≤45 mg/cartridge

基质

Multimedia Durapore®

pore size

0.5/0.22 μm pore size

泡点

≥3450 mbar (50 psig), air with water

代码

Code 0

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相关类别

一般描述

Device configuration: Cartridge
Cartridge type: Liquid

包装

Double Easy-Open bag

制备说明

Sterilization Method: 6 autoclave or SIP cycles of 30 min at 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: The extractables level was ≤ 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 10 L

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 to 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

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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