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Key Documents

MCSL20S02

Millipore

Durapore® 5.0 µm,Millidisk®小柱

Millidisk® 20, filtration area 1000 cm2, hydrophilic

同義詞:

Millidisk Cartridge 20-stack 5.0 μm Hydrophilic

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690

材料

PVDF
polysulfone
polysulfone support
silicone seal

品質等級

無菌

non-sterile

滅菌相容性

autoclavable compatible
steam-in-place compatible

產品線

Millidisk® 20

特點

hydrophilic

製造商/商標名

Millidisk®

參數

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward)
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse)
0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward)
75 L/min flow rate at 2.8 bar (ΔP)

技術

prefiltration: suitable

過濾面積

1000 cm2

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

5.0 μm pore size

輸入

sample type liquid

起泡點

≥138 mbar (2 psig), air with water at 23 °C

柱代碼

not applicable

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一般說明

Device Configuration: Cartridge
Stack Design: 20 Stak

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
5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
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: using sterilized device after 24 hours in water at controlled room temperature

法律資訊

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

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