CLGL73TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Synonim(y): Durapore^® II Cartridge Filter 30 in. 0.22 m Code 7, Durapore^® 0.22 µm, High Area, Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: Durapore^® High Area Cartridge, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 30 in. Code 7
• Quality Segment: 400
• material: polypropylene support, PVDF membrane, polypropylene housing, polypropylene vent cap, silicone O-ring
• 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: 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
• technique(s): sterile filtration: suitable
• L: 30 in.
• W: 2.7 in.
• cartridge nominal length: 30 in. (75 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 3.21 m²
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤90 mg/cartridge
• matrix: Durapore^® High Area
• pore size: 0.22 μm pore size
• input: sample type liquid
• bubble point: ≥3450 mbar (50.0 psi), air with water at 23 °C
• cartridge code: Code 7 (2-226; O-rings w/locking-tabs)

Opis

General description

Device Configuration: Cartridge

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

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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