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安全信息

KGW6A02FF3

Millipore

Polysep™ II 1.0/0.5 µm nominal, Opticap® XL Capsule

inlet connection diam. 3/4 in., Opticap® XL 2, pore size 1.0/0.5 μm, cartridge nominal length 2 in. (5 cm)

别名:

Opticap XL2 Polysep II 1.0/0.5 μm 3/4 in. TC/TC

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About This Item

UNSPSC代码:
23151806
eCl@ss:
32031610

物料

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
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

产品线

Opticap® XL 2

特点

hydrophilic

制造商/商品名称

Opticap®

参数

1.0 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

长度

14.2 cm (5.6 in.)

宽度

3.3 in.

纯化柱标称长度

2 in. (5 cm)

直径

14.5 cm (5.7 in.)

过滤面积

0.06 m2

入口接头直径

3/4 in.

入口至出口宽度

14.2 cm (5.6 in.)

出口接头直径

3/4 in.

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/capsule

基质

Polysep™ II

pore size

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

输入

sample type liquid

配件

inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

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相关类别

一般描述

Device Configuration: 取样皿滤膜

特点和优势

Format: Double Layer

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
3 autoclave cycles of 30 min @ 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 21 CFR 210.3 (b) (6).

分析说明

Gravimetric Extractables: after a 600 mL flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

法律信息

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

免责声明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

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