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CLVL02TP3

Durapore® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 20 in. (50 cm), Code 0

Synonym(s):

Durapore® 0.1 µm, High Area, Cartridge

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About This Item

UNSPSC Code:
23151806
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Product Name

Durapore® High Area Cartridge, Chemistry: 0.1 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 20 in. Code 0

Quality Segment

400

material

PVDF membrane, polypropylene support, silicone O-ring

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

autoclavable compatible
steam-in-place compatible

product line

Durapore®

feature

hydrophilic

manufacturer/tradename

Durapore® II

technique(s)

sterile filtration: suitable

L

20 in.

W

2.7 in.

cartridge nominal length

20 in. (50 cm)

device size

20 in.

filtration area

2.2 m2

impurities

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

gravimetric extractables

≤30 mg/cartridge

matrix

Durapore® High Area  

pore size

0.1 μm pore size

code

Code 0

General description

Device configuration: Cartridge
Cartridge type: Liquid

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.
Gravimetric Extractables: The extractables level was ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature. 

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 to 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

Legal Information

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

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Certificates of Analysis (COA)

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