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Merck
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MPHL20CF3

Millipore

可γ辐照 Millipak -200 过滤单元 0.45 µm 3/4 in.TC/TC

Millipak® 200, filtration area 1000 cm2, matrix Durapore®

别名:

Millipak®囊式过滤器,带Durapore® 0.45 µm滤膜

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About This Item

分類程式碼代碼:
23151806

材料

PVDF
PVDF vent cap
polycarbonate
polycarbonate support

品質等級

無菌

irradiated
non-sterile

滅菌相容性

gamma compatible

產品線

Millipak® 200

特點

gamma compatible
hydrophilic

製造商/商標名

Millipak®

參數

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
19 L/min flow rate at 3.2 bar (ΔP)
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
5.2 bar max. inlet pressure (75 psi) at 25 °C

技術

bioburden reduction: suitable

長度

6.0 in.

寬度

3.0 in.

過濾面積

1000 cm2

入口接頭直徑

3/4 in.

出口接頭直徑

3/4 in.

雜質

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

重量法萃取物

≤5 mg/device

基質

Durapore®

孔徑

0.45 μm

起泡點

≥1790 mbar (26 psig), air with water at 23 °C

接頭

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

相关类别

一般說明

Device Configuration: 取样皿滤膜

包裝

Double Easy-Open bag

其他說明

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.

準備報告

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).

分析報告

使用 ≥200 mL 水冲洗后,将符合“USP 氧化物检测”要求
Gravimetric Extractables: after 24 hours in water at controlled room temperature

法律資訊

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

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