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CVGB75S01

Hydrophobic Durapore® 0.22 µm, Cartridge

pore size 0.22 μm, cartridge nominal length 5 in. (12.5 cm), Code 7

Synonym(s):

Durapore Cartridge Filter 5 in. 0.22 µm hydrophobic Code 7, 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 7

Quality Segment

400

material

PVDF , polypropylene , polypropylene support, silicone seal

sterility

non-sterile

sterilization compatibility

steam-in-place compatible

product line

Durapore®

feature

hydrophobic

manufacturer/tradename

Durapore®

parameter

≤5 mL/min nitrogen diffusion at 1.7 bar (25 psig) and 23 °C (with 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), 3.5 bar max. inlet pressure (50 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)

sterile filtration: suitable

L

5 in.

W

2.7 in.

cartridge nominal length

5 in. (12.5 cm)

diam.

6.9 cm (2.7 in.)

filtration area

0.35 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

≤10 mg

matrix

Durapore®

pore size

0.22 μm pore size

bubble point

≥1240 mbar (18 psig), nitrogen with 60/40% IPA/water at 23 °C

cartridge code

Code 7

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
30 SIP cycles of 30 min @ 126 °C; 30 autoclave cycles of 60 min @ 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.
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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