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Merck
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CVDI01TPT

Durapore CVDI 筒式过滤器 10 in.0.2 µm 0 号

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

别名:

Durapore® CBR 0.2 µm，小柱

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eCl@ss:
27293007
UNSPSC Code:
23151806

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产品名称

Durapore CVDI 筒式过滤器 10 in.0.2 µm 0 号, pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

material

PVDF

reg. compliance

meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food)
meets FDA Indirect Food Additive requirements cited in 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®

technique(s)

bioburden reduction: suitable

L

10 in.

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

filtration area

0.69 m2

gravimetric extractables

≤25 mg/cartridge

matrix

Durapore®

pore size

0.2 μm pore size

input

sample type liquid

cartridge code

Code 0 (2-222; O-rings)

Quality Level

400

相关类别

General description

Device Configuration: Cartridge

Analysis Note

Bacterial Retention
Samples of the Durapore® membrane used in this cartridge were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM F838 methodology.
Gravimetric Extractables: 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 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.

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).

Legal Information

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

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