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Merck
CN

CVDR01PP3

Durapore® 0.65 µm, Cartridge

cartridge nominal length 10 in. (25 cm), Code 0

Synonym(s):

Durapore® 0.65 µm, Cartridge

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About This Item

UNSPSC Code:
23151806

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Product Name

Durapore® Cartridge, Chemistry: 0.65 µm Hydrophilic Polyvinylidene Fluoride (PVDF)Configuration: 10 in. Code 0

material

PVDF membrane, silicone O-ring

reg. compliance

meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food), meets FDA 21 CFR 177-182 (all component materials)

Quality Level

400

sterility

non-sterile

sterilization compatibility

autoclavable compatible
steam-in-place compatible

product line

Durapore®

feature

hydrophilic

manufacturer/tradename

Durapore®

technique(s)

prefiltration: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

device size

10 in.

filtration area

0.69 m2

impurities

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

gravimetric extractables

≤20 mg/cartridge

matrix

Durapore®

pore size

0.65 μm pore size

code

Code 0

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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

Gravimetric Extractables: The extractables level was ≤ 20 mg per 10-inch cartridge after 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

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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