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Merck
CN

CHGL02TP3

Multilayer Durapore® 0.45/0.22 µm, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 0

别名:

Multilayer Durapore® 0.45/0.22 µm, Cartridge

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UNSPSC Code:
23151806

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产品名称

多层Durapore® 0.45/0.22 µm，筒式, Chemistry: 0.45 / 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 20 in. Code 0

material

polypropylene device, polypropylene support, silicone seal

reg. compliance

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

≤21.6 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

20 in.

W

2.7 in.

cartridge nominal length

20 in. (50 cm)

device size

20 in.

filter diam.

2.7 in. (6.9 cm)

filter filtration area

1.1 m2

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Multilayer Durapore®

pore size

0.45/0.22 μm pore size

bubble point

≥3450 mbar (50 psig), air with water

code

Code 0

相关类别

General description

Device configuration: Cartridge
Cartridge type: Liquid

Preparation Note

Sterilization Method: 30 SIP cycles of 30 min at 135°C; 30 autoclave cycles of 60 min at 126°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.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 3L

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

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