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SMP2A25NB6

Milligard® PES 1.2/0.2 µm nominal, OptiScale® Capsule

filtration area 3.5 cm², OptiScale® 25, pore size 1.2/0.2 μm

Synonym(s):

OptiScale 25 Milligard PES 1.2/0.2 m nominal NB, Milligard® PES 1.2/0.2 µm nominal, OptiScale® Capsule

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About This Item

UNSPSC Code:
23151806
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Product Name

OptiScale® 25 CapsuleMedia: Milligard® PES 1.2/0.2 µm Nominal,

Quality Segment

400

material

polyethersulfone membrane, polypropylene , polypropylene support, polypropylene vent cap

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)

technique(s)

bioburden reduction: 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

1.2/0.2 μm nominal pore size, 1.2/0.2 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

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.

Other Notes

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.

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

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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