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Merck
CN
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文件

K002A05FF1

Millipore

Opticap XL5 Clarigard 0.2 µm 3/4 in.TC/TC

inlet connection diam. 3/4 in., pore size 0.2 μm, cartridge nominal length 5 in. (12.5 cm)

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别名:
Opticap® XL1 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

21.6 cm (8.5 in.)

纯化柱标称长度

5 in. (12.5 cm)

直径

10.7 cm (4.2 in.)

入口接头直径

3/4 in.

入口至出口宽度

21.6 cm (8.5 in.)

出口接头直径

3/4 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

≤10 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
19 mm (3/4 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 ≥2 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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