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Merck
CN

KHVEG1TTT1H

Millipore

Millipore Express® SHRP High Area, Opticap® XLT Capsule

Opticap® XLT 10, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

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UNSPSC代码:
23151806

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物料

polyester support
polypropylene housing
polypropylene vent cap (gamma stable)
silicone seal

质量水平

400

管理合规性

meets FDA 21 CFR 177-182 (all component materials)

无菌性

non-sterile

灭菌适用性

gamma compatible

产品线

Opticap® XLT 10

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

≤54.2 mL/min air diffusion at 3.45 bar (50 psig) (in water)
0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse)
1 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet pressure
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
80 psig max. inlet pressure

技术

sterile filtration: suitable

长度

14.8 in.

宽度

4.2 in.

纯化柱标称长度

10 in. (25 cm)

过滤器直径

4.2 in. (10.7 cm)

过滤器尺寸

10 in.

过滤面积

1.0 m2

杂质

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)

基质

Millipore Express® SHR ((w/Prefilter High Area))

pore size

0.5/0.1 μm pore size

泡点

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water

配件

1/4 in. drain/vent connection ( hose barb with double o-ring seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

应用

filtration

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一般描述

Device Configuration: Capsule

特点和优势

T-line/Gauge Port: T-line

包装

Double Easy-Open bag

制备说明

Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 123 °C; not in-line steam sterilizable

This product was manufactured with a MILLIPORE EXPRESS® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析说明

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.

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 wetting instructions of Filters with MILLIPORE EXPRESS® Membrane user guide
  • Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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