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CVGB75S01 Millipore

Durapore Cartridge Filter 5 in. 0.22 µm hydrophobic Code 7

  •  eCl@ss 27293007

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Properties

Quality Level   400
material   PVDF
  polypropylene
  polypropylene support
  silicone seal
feature   hydrophobic
mfr. no.   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)
cartridge nominal length   5 in. (12.5 cm)
diam.   6.9 cm (2.7 in.)
filtration area   0.35 m2
overall size   5 in.
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

Description

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

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

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

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

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.
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