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Merck
CN

CVDR51TP3

Durapore® (w/Prefilter) 0.65 µm, Cartridge

cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm), Code 5

别名:

Durapore® (w/Prefilter) 0.65 µm, Cartridge

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UNSPSC Code:
23151806

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产品名称

Durapore®（带预滤器）0.65 µm，小柱, Chemistry: 0.65 µm Hydrophilic Polyvinylidene Fluoride (PVDF)Configuration: 10 in. Code 5

material

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

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®

parameter

≤10 mL/min air diffusion at 620 mbar (9 psig) (in water), 0.35 bar max. differential pressure (5 psid) at 121 °C (forward), 0.35 bar max. inlet pressure (5 psi) at 121 °C (forward), 1.7 bar max. differential pressure (25 psid) at 25 °C (reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward), 1.7 bar max. inlet temp. (25 psi) at 25 °C (reverse), 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)

prefiltration: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

device size

10 in.

filter diam.

2.7 in. (6.9 cm)

filter filtration area

0.69 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

Durapore® (w/Prefilter)

pore size

0.65 μm pore size

bubble point

≥965 mbar (14 psig), air with water

code

Code 5

General description

Device configuration: Cartridge
Cartridge type: Liquid

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: 8 SIP cycles of 30 min or 8 autoclave cycles of 60 min at 121°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

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 ≥ 1 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

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

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