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安全信息

MPVL2GCF3

Millipore

无菌 Millipak -200 过滤单元 0.1 µm 3/4 in.TC/TC

Millipak® 200, sterile

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别名:
Millipak®-200囊式过滤装置
UNSPSC代码:
23151806

物料

PVDF
PVDF vent cap
polycarbonate
polycarbonate support

质量水平

400

无菌性

irradiated
sterile

产品线

Millipak® 200

特点

hydrophilic

制造商/商品名称

Millipak®

参数

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward)
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
100 L process volume
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
5.2 bar max. inlet pressure (75 psi) at 25 °C
8.5 L/min flow rate at 2.45 bar (ΔP)

技术

sterile filtration: suitable

过滤面积

1000 cm2

入口接头直径

3/4 in.

出口接头直径

3/4 in.

杂质

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

重量萃取物

≤5 mg/device

基质

Durapore®

孔径

0.1 μm

泡点

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

配件

inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

相关类别

一般描述

Device Configuration: Gamma Gold Capsule

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
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
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.
使用 ≥200 mL 水冲洗后，将符合“USP 氧化物检测”要求
Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature

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
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

法规信息

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