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CVGB05S01

Hydrophobic Durapore® 0.22 µm, Cartridge

pore size 0.22 μm, Code 0 (2-222; O-rings)

Synonym(s):

Durapore® Cartridge Filter 5 in. 0.22 µm hydrophobic Code 0, Hydrophobic Durapore® 0.22 µm, Cartridge

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About This Item

eCl@ss:
27293007
UNSPSC Code:
23151806
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Product Name

Durapore® Cartridge, Chemistry: 0.22 µm Hydrophobic Polyvinylidene Fluoride (PVDF)Configuration: 5 in. Code 0

material

PVDF

Quality Segment

400

sterility

non-sterile

sterilization compatibility

steam-in-place compatible

product line

Durapore®

feature

hydrophobic

manufacturer/tradename

Durapore®

technique(s)

sterile filtration: suitable

L

5 in.

W

2.7 in.

cartridge nominal length

5 in.

filtration area

0.35 m2

impurities

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

gravimetric extractables

≤10 mg

matrix

Durapore®

pore size

0.22 μm pore size

cartridge code

Code 0 (2-222; O-rings)

General description

Device Configuration: Cartridge

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).

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: after 24 hours in a 70/30% IPA/water mixture 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.

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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Certificates of Analysis (COA)

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