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安全信息

CGW671S48

Millipore

PolysepII 1.0/0.5 µm 标称,小柱

cartridge nominal length 10 in. (25 cm), filter diam. 2.8 in.

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About This Item

UNSPSC代码:
23151806

物料

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene device
polypropylene support (spun bonded)
silicone seal

质量水平

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 II

参数

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

技术

prefiltration: suitable

长度

10 in.

宽度

2.7 in.

纯化柱标称长度

10 in. (25 cm)

设备尺寸

10 in.

过滤器直径

2.8 in.

过滤器过滤面积

0.46 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

1.0/0.5 μm nominal pore size
1.0/0.5 μm pore size

柱代码

Code 7

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一般描述

Device Configuration: Cartridge
Cartridge Type: Liquid
Filter Grade: Prefilter

应用

mAb & r-protein intermediates; Plasma; Vaccines & viral vectors; SVPs LVPs; Cell Culture; Media Filtration; Colloid Removal; Lipid Removal

特点和优势

Format: Double Layer

包装

Double Easy-Open bag

制备说明

Sanitization: 30 min with hot water at 80 °C
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a Millipore® media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析说明

After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature, extractables level was ≤140 mg per 10-inch element after a 5000 mL flush.
Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of 5000 mL per 10 inch Element

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

The product is manufuactured in a facility with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard.

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

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