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MFGL04GF3

Durapore^® 0.22 µm, Millipak^® Final Fill灌装囊式过滤器

Name: Durapore<SUP>®</SUP> 0.22 µm, Millipak<SUP>®</SUP> Final Fill灌装囊式过滤器
Brand: MM

non-sterile (non-sterilized), Millipak^® Final Fill 40, pore size 0.22 μm

别名:

Millipak^® Final Fill 40

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About This Item

UNSPSC代码:

23151806

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物料

PVDF membrane
polysulfone device
polysulfone support

质量水平

400

Agency

certified by the ISO 9001:2015 (Quality Management Systems)
meets requirements for EP 2.6.14
meets requirements for JP 4.01
meets requirements for USP 85

无菌性

irradiated
non-sterile (non-sterilized)

灭菌适用性

gamma compatible

产品线

Millipak^® Final Fill 40

特点

hydrophilic

包装

bag of 3 × double easy-open bag

参数

1.0 L/min flow rate at 0.69 bar
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 25 °C (Forward)
50 psi max. differential pressure (3.5 bar) at 25 °C (Forward)
60 psi max. differential pressure (4.1 bar) at 25 °C (Forward)
60 psi max. inlet pressure (4.1 bar) at 25 °C
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
80 psi max. inlet pressure (5.5 bar) at 25 °C

技术

sterile filtration: suitable

长度

3.4 in.

宽度

3.0 in.

过滤面积

200 cm²

杂质

<0.25 EU/mL bacterial endotoxins (LAL test)

基质

Durapore^®

孔径

0.22 μm pore size

泡点

≥50 psi (3450 mbar), air with water at 23 °C

配件

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

一般描述

Device Configuration: Capsule

包装

Double Easy-Open bag

制备说明

Sterilization Method
Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 <nbsp/>°C. Devices can withstand a dose ? 40<nbsp/> kGy gamma exposure.

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.

分析说明

Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per AST F838 methodology.

其他说明

Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.

法律信息

ATCC is a registered trademark of American Type Culture Collection

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

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

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Durapore^® 0.22 µm, Millipak^® Final Fill灌装囊式过滤器