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Merck
CN

CVDI03TPS

Durapore CVDI 筒式过滤器 30 in.0.22 µm 0 号 硅橡胶

pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings)

别名:

Durapore® CBR 0.2 µm，小柱

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eCl@ss:
32031690
UNSPSC Code:
23151806

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产品名称

Durapore CVDI 筒式过滤器 30 in.0.22 µm 0 号 硅橡胶, pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings)

material

PVDF
polypropylene
polypropylene support
silicone seal

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®

parameter

≤40 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)

technique(s)

bioburden reduction: suitable

L

30 in.

W

2.7 in.

cartridge nominal length

30 in. (75 cm)

diam.

6.9 cm (2.7 in.)

filtration area

2.07 m2

gravimetric extractables

≤75 mg/cartridge

matrix

Durapore®

pore size

0.2 μm pore size

input

sample type liquid

bubble point

≥3100 mbar (45 psig), air with water at 23 °C

cartridge code

Code 0 (2-222; O-rings)

Quality Level

400

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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