CVSC01TP3

Multimedia Durapore^® 1.2/0.5/0.22 µm, Cartridge

cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm), Code 0

• Kod UNSPSC: 23151806

Właściwości

• Materiały: mixed cellulose esters (MCE) prefilter; polypropylene device; polypropylene support; silicone seal
• 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^®
• Parametry: ≤10.8 mL/min air diffusion at 2.75 bar (40 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (reverse; intermittent); 3.5 bar max. inlet temp. (50 psi) at 25 °C (reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (forward)
• metody: sterile filtration: suitable
• Długość: 10 in.
• Szerokość: 2.7 in.
• długość nominalna kartridża: 10 in. (25 cm)
• device size: 10 in.
• śr. filtra: 2.7 in. (6.9 cm)
• filter filtration area: 0.56 m²
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤70 mg/cartridge
• macierz: Multimedia Durapore^®
• pore size: 1.2/0.5/0.22 μm pore size
• punkt pęcherzykowania: ≥3450 mbar (50 psig), air with water
• kod: Code 0

Opis

Opis ogólny

Device configuration: Cartridge
Cartridge type: Liquid

Opakowanie

Double Easy-Open bag

Uwaga dotycząca przygotowania

Sterilization Method: 6 autoclave or SIP cycles of 30 min at 123°C

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 ≤ 70 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 L

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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