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MSP010013

Millipak® Barrier Capsule Media: Durapore® 0.22 µm

Chemistry: Hydrophobic/Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange

Synonym(s):

Durapore Millipak Barrier 200, 0.22 μm, Hydrophobic/Hydrophilic, TC/TC, Hydrophilic/Hydrophobic Durapore® 0.22 µm, Millipak® Barrier 200 Capsule

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Millipak® Barrier Capsule Media: Durapore® 0.22 µm, Chemistry: Hydrophobic/Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange

material

PVDF

Quality Segment

400

description

hydrophobic/hydrophilic

sterility

irradiated, non-sterile

sterilization compatibility

gamma compatible

product line

Millipak® Barrier 200

feature

hydrophilic, hydrophobic

manufacturer/tradename

Durapore®

technique(s)

sterile filtration: suitable

L

6.1 in.

W

3.0 in.

filtration area

1000 cm2

inlet connection diam.

1.5 in.

outlet connection diam.

1.5 in.

impurities

<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Durapore®

pore size

0.22 μm

fitting

inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

General description

Device Configuration: Capsule

Preparation Note

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).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.

Other Notes

Directions for Use

  • Organism Retention: Microorganism
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • 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

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

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Certificates of Analysis (COA)

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