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SMP8A25NB6

Millipore

Milligard® PES 1.2/0.8 µm, OptiScale® Capsule

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

Synonym(s):

OptiScale 25 Milligard PES 1.2/0.8 μm NB

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About This Item

UNSPSC Code:
23151806

material

polyethersulfone membrane
polypropylene
polypropylene support
polypropylene vent cap

Quality Level

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible

product line

OptiScale® 25

feature

hydrophilic

manufacturer/tradename

OptiScale®

parameter

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)

technique(s)

prefiltration: suitable

L

3.9 cm (1.52 in.)

W

1.21 in.

diam.

3.1 cm (1.2 in.)

filtration area

3.5 cm2

impurities

<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)

matrix

Milligard® PES

pore size

1.2/0.8 μm pore size

fitting

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

cartridge code

not applicable

General description

Device Configuration: Capsule

Other Notes

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.

Preparation Note

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.

Analysis Note

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

Legal Information

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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Aseptic filters are offered in disposable capsules and cartridge formats. This guide will help you find the right format for your bioburden control.

Aseptic filters are offered in disposable capsules and cartridge formats. This guide will help you find the right format for your bioburden control.

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