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Merck
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KVVLS04HH3

Millipore

Opticap 无菌除菌级 XL4 Durapore 0.1 µm 9/16 in.HB/HB

Opticap® XL 4, sterile, inlet connection diam. 9/16 in., cartridge nominal length 4 in. (10 cm)

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别名:
Durapore® 0.1 µm，Opticap® XL囊式
UNSPSC代码:
23151806

物料

PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring

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

irradiated
sterile

产品线

Opticap® XL 4

特点

hydrophilic

制造商/商品名称

Opticap®

参数

≤5.7 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.8 bar max. differential pressure (40 psid) at 25 °C (Reverse; intermittent)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

技术

sterile filtration: suitable

长度

17.0 cm (6.7 in.)

纯化柱标称长度

4 in. (10 cm)

直径

6.1 cm (2.4 in.)

过滤面积

0.18 m2

入口接头直径

9/16 in.

出口接头直径

9/16 in.

杂质

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

基质

Durapore®

孔径

0.1 μm

输入

sample type liquid

泡点

≥4830 mbar (70 psig), air with water at 23 °C

配件

1/4 in. drain/vent hose barb (with double O-ring Seal)
 inlet hose barb
 outlet hose barb
 (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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 Wetting Instructions for Filter Units with Durapore® Membrane 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
Shipped sterile by gamma irradiation @ >25 kGray gamma exposure
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析说明

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
Durapore 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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