CLGL71TP3

Durapore^® 0.22 µm, High Area, Cartridge

cartridge nominal length 10 in. (25 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Synonym(s): Durapore^® II Cartridge Filter 10 in. 0.22 m Code 7
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• parameter: ≤20.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
• technique(s): sterile filtration: suitable
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 1.1 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: ≤30 mg/cartridge
• matrix: Durapore^® High Area
• pore size: 0.22 μm
• input: sample type liquid
• bubble point: ≥3450 mbar (50 psig), air with water at 23 °C
• cartridge code: Code 7 (2-226; O-rings w/locking-tabs)

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 a 1.5 L flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL

Legal Information

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

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