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
• UNSPSC Code: 23151806
• eCl@ss: 27293007

Properties

• material: PVDF
• Quality Level: 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)

Description

General description

Device Configuration: Cartridge

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

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