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Key Documents

SMP8A25NB6

Millipore

OptiScale 25 Milligard PES 1.2/0.8 um NB

filtration area 3.5 cm2, OptiScale® 25, pore size 1.2/0.8 μm

别名:

Milligard® PES 1.2/0.8 µm, OptiScale® 囊式

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About This Item

分類程式碼代碼:
23151806

材料

polyethersulfone membrane
polypropylene
polypropylene support
polypropylene vent cap

品質等級

無菌

non-sterile

滅菌相容性

autoclavable compatible

產品線

OptiScale® 25

特點

hydrophilic

製造商/商標名

OptiScale®

參數

0 bar max. differential pressure (Reverse)
4.14 bar max. differential pressure (60 psi) at 25 °C (Forward)
60 psi max. inlet pressure (4.1 bar)

技術

prefiltration: suitable

長度

3.9 cm (1.52 in.)

寬度

1.21 in.

直徑

3.1 cm (1.2 in.)

過濾面積

3.5 cm2

雜質

<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)

基質

Milligard® PES

pore size

1.2/0.8 μm pore size

接頭

female Luer-Lok® inlet connection
male Luer-Lok® outlet connection
(Female Luer-Lok® Inlet/Male Luer Slip Outlet)

柱代碼

not applicable

一般說明

Device Configuration: 取样皿滤膜

其他說明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use

  • Organism Retention: Bacterial
  • Mode of Action: Filtration (size exclusion)
  • Application: Protein purification
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer installation and wetting sections of OPTISCALE®-25 user guide
  • Storage Statement: Please refer OPTISCALE®-25 user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

準備報告

Devices tested and meet requirements of USP <78> for large volume parenterals.
Sterilization Method
Capsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.

分析報告

This product was tested and passes the USP test for particulates in injectables.

法律資訊

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany

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