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安全信息

CGW304S03

Millipore

Polysep™II 1.0/0.2 µm 标称，小柱

pore size 1.0/0.2 μm, cartridge nominal length 100 cm (40 in.), filter diam. 7.1 cm (2.8 in.)

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UNSPSC代码:
23151806

物料

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene prefilter
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

Polysep™

特点

hydrophilic

制造商/商品名称

Polysep™

参数

3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C

技术

prefiltration: suitable

长度

40 in.

宽度

2.7 in.

纯化柱标称长度

100 cm (40 in.)

过滤器直径

7.1 cm (2.8 in.)

filter filtration area

1.84 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 )

基质

Polysep™ II

pore size

1.0/0.2 μm nominal pore size
1.0/0.2 μm pore size

柱代码

Code 0

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相关类别

一般描述

Device Configuration: Cartridge

特点和优势

Double Layer

包装

Double Easy-Open bag

制备说明

Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C

分析说明

Gravimetric Extractables: the extractables level was equal to or less than 140 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 ≥ 20 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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer Mixed cellulose esters Tech Brief
  • 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

Polysep is a trademark of Sigma-Aldrich Co. LLC

法规信息

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