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Merck
CN
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安全信息

KGW2A05HH1

Millipore

Polysep™ II 1.0/1.2 µm nominal, Opticap® XL Capsule

Opticap® XL 5, pore size 1.2/1.0 μm, cartridge nominal length 5 in. (12.5 cm), filter diam. 5.7 in. (14.5 cm)

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UNSPSC代码:
23151806

物料

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene filter
polypropylene housing
polypropylene support
silicone seal

质量水平

400

管理合规性

FDA 21CFR177-182 (all component materials)

无菌性

non-sterile

灭菌适用性

autoclavable compatible

产品线

Opticap® XL 5

特点

hydrophilic

制造商/商品名称

Opticap®

参数

1 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

技术

prefiltration: suitable

纯化柱标称长度

5 in. (12.5 cm)

device L

21.6 cm (8.5 in.)

device size

5 in.

过滤器直径

5.7 in. (14.5 cm)

filter filtration area

0.19 m2

入口接头直径

9/16 in.

inlet to outlet width

21.6 cm (8.5 in.)

出口接头直径

9/16 in.

杂质

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

基质

Polysep™ II

pore size

1.0/1.2 μm nominal pore size
1.2/1.0 μm pore size

配件

(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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相关类别

一般描述

Device Configuration: Capsule

特点和优势

Double Layer

包装

Double Easy-Open bag

制备说明

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

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).

分析说明

Gravimetric Extractables: ≤ 61 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 2 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

法律信息

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

法规信息

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