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Merck
CN
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文件

K002A10TT1

Millipore

Opticap XL10 Clarigard 0.2 µm 1-1/2 in.TC/TC

inlet connection diam. 1.5 in., pore size 0.2 μm, cartridge nominal length 10 in. (25 cm)

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别名:
Opticap® XL10 Clarigard过滤器®
UNSPSC代码:
23151806
eCl@ss:
32031690

物料

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)

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.
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

长度

33.5 cm (13.2 in.)

纯化柱标称长度

10 in. (25 cm)

直径

10.7 cm (4.2 in.)

入口接头直径

1.5 in.

入口至出口宽度

33.5 cm (13.2 in.)

出口接头直径

1.5 in.

杂质

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

重量萃取物

≤15 mg/capsule

基质

Clarigard®

孔径

0.2 μm nominal pore size
0.2 μm pore size

输入

sample type liquid

配件

inlet sanitary flange
38 mm (1 1/2 in.) inlet/outlet sanitary flange
 outlet sanitary flange

相关类别

一般描述

Device Configuration: 取样皿滤膜

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location.
  • 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 @ 126 °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 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

法律信息

CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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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