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Safety Information

CV0603TP3

Millipore

Multimedia Durapore® 0.5/0.22 µm, Cartridge

cartridge nominal length 30 in. (75 cm), filter diam. 2.7 in. (6.9 cm), Code 0

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UNSPSC Code:
23151806

material

mixed cellulose esters (MCE) prefilter
polypropylene device
polypropylene support
silicone seal

Quality Level

400

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®

parameter

≤40 mL/min air diffusion at 2.75 bar (40 psig) (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (reverse; intermittent)
3.5 bar max. inlet temp. (50 psi) at 25 °C (reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C (forward)

technique(s)

sterile filtration: suitable

L

30 in.

W

2.7 in.

cartridge nominal length

30 in. (75 cm)

device size

30 in.

filter diam.

2.7 in. (6.9 cm)

filter filtration area

2.07 m2

impurities

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

gravimetric extractables

≤45 mg/cartridge

matrix

Multimedia Durapore®

pore size

0.5/0.22 μm pore size

bubble point

≥3450 mbar (50 psig), air with water

code

Code 0

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General description

Device configuration: Cartridge
Cartridge type: Liquid

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: 6 autoclave or SIP cycles of 30 min at 123°C

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 ≤ 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 15 L

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

Regulatory Information

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