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KPGES3TTT1

Millipore

Opticap XLT 30 Millipore Express PHF 无菌 0.2 µm 1-1/2 in.TC

Opticap® XLT 30, sterile, inlet connection diam. 1.5 in., cartridge nominal length 30 in. (75 cm)

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别名:
Millipore Express® PHF, Opticap® XLT 囊式
UNSPSC代码:
23151806

物料

polyester support
polyethersulfone
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
polysulfone
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

irradiated
sterile

产品线

Opticap® XLT 30

特点

hydrophilic

制造商/商品名称

Millipore Express®

参数

≤98.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1000 bar max. differential pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
5500 mbar max. differential pressure (80 psi) at 25 °C
80 psig max. inlet pressure

技术

bioburden reduction: suitable

长度

87.1 cm (34.3 in.)

纯化柱标称长度

30 in. (75 cm)

直径

10.7 cm (4.2 in.)

过滤面积

1.71 m2

入口接头直径

1.5 in.

入口至出口宽度

15.2 cm (6.0 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)

基质

Millipore Express® PHF

孔径

0.2 μm

配件

1/4 in. drain/vent hose barb (with double O-ring seal)
 inlet sanitary flange
 outlet sanitary flange
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

一般描述

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 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.

制备说明

Sterilization Method
3 autoclave cycles of 60 min @ 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

Bacterial Retention
Samples of membrane used in this filter 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 of 33 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L

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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