CLVL03TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 30 in. (75 cm), Code 0

• Kod UNSPSC: 23151806

Właściwości

• Materiały: PVDF membrane; polypropylene support; silicone O-ring
• Poziom jakości: 400
• zgodność regionalna: meets FDA 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible; steam-in-place compatible
• linia produktu: Durapore^®
• Właściwości: hydrophilic
• producent / nazwa handlowa: Durapore^® II
• metody: sterile filtration: suitable
• Długość: 30 in.
• Szerokość: 2.7 in.
• długość nominalna kartridża: 30 in. (75 cm)
• device size: 30 in.
• powierzchnia filtracyjna: 3.3 m²
• zanieczyszczenia: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤30 mg/cartridge
• macierz: Durapore^® High Area
• wielkość porów: 0.1 μm pore size
• kod: Code 0

Opis

Opis ogólny

Device configuration: Cartridge
Cartridge type: Liquid

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

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: The extractables level was ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature. 

Inne uwagi

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 to 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

Informacje prawne

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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