CLVL72TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 20 in. (50 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Synonym(s): Durapore^® II Cartridge Filter 20 in. 0.1 m Code 7, Durapore^® 0.1 µm, High Area, Cartridge
• eCl@ss: 27293007
• UNSPSC Code: 23151806

Properties

• Product Name: Durapore^® High Area Cartridge, Chemistry: 0.1 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 20 in. Code 7
• material: PVDF
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤60 mg/cartridge
• matrix: Durapore^® High Area
• pore size: 0.1 μm pore size
• input: sample type liquid
• Quality Level: 400
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®
• feature: hydrophilic
• manufacturer/tradename: Durapore^® II
• technique(s): sterile filtration: suitable
• L: 20 in.
• W: 2.7 in.
• cartridge nominal length: 20 in. (50 cm)
• filtration area: 2.2 m²
• cartridge code: Code 7 (2-226; O-rings w/locking-tabs)

Description

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

General description

Device Configuration: Cartridge

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.

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).

Legal Information

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

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