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Merck
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Key Documents

9Z2786

Millipore

Non-sterilized Millipak® Final Fill 100 Filter Unit 0.45  µm 1 1/2  in. TC/TC

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690

材料

PVDF
polysulfone
polysulfone support

品質等級

無菌

(Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ? 40  kGy gamma exposure.)
non-sterile

特點

hydrophilic

參數

10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
3.0 L/min flow rate at 0.69 bar
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
80 psi max. inlet pressure (5.5 bar) at 25 °C

過濾面積

500 cm2

入口接頭直徑

1 1/2 in.

出口接頭直徑

1-1/2 in.

尺寸

100 L

雜質

<0.25 EU/mL Aqueous extraction (LAL test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.)

基質

Durapore®

孔徑

0.45 μm

起泡點

≥26 psi (1790 mbar), air with water

接頭

inlet sanitary flange
outlet sanitary flange
38 mm (1 1/2 in.) sanitary flange drain/vent

適合性

suitable for endotoxin (Aqueous extraction contains < 0.25<nbsp/> EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.)

一般說明

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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

包裝

Double Easy-Open bag

法律資訊

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

免責聲明

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

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