KVVLA02FH3

Durapore^® 0.1 µm, Opticap^® XL Capsule

Opticap^® XL 2, cartridge nominal length 2 in. (5 cm), filter diam. 5.7 in. (14.5 cm)

• Kod UNSPSC: 23151806

Właściwości

• Materiały: polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Poziom jakości: 400
• zgodność regionalna: FDA 21CFR177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible
• linia produktu: Opticap^® XL 2
• Właściwości: hydrophilic
• producent / nazwa handlowa: Opticap^®
• Parametry: ≤3.5 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water); 1 bar max. inlet pressure (15 psi) at 80 °C; 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward:); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) 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 23 °C; 80 psig max. inlet pressure
• metody: sterile filtration: suitable
• długość nominalna kartridża: 2 in. (5 cm)
• device L: 14.0 cm (5.5 in.)
• device size: 2 in.
• śr. filtra: 5.7 in. (14.5 cm)
• filter filtration area: 0.2 m²
• śr. przyłącza doprowadzającego: 3/4 in.
• inlet to outlet width: 14 cm (5.5 in.)
• śr. przyłącza odprowadzającego: 9/16 in.
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• macierz: Durapore^®
• wielkość porów: 0.1 μm pore size
• punkt pęcherzykowania: ≥4830 mbar (70 psig), air with water at 23 °C
• dopasowywanie: 19 mm (3/4 in.) fitting (sanitary flange inlet/oulet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Opis

Opis ogólny

Device Configuration: Capsule

Opakowanie

Double Easy-Open bag

Uwaga dotycząca przygotowania

Sterilization Method:
3 autoclave cycles of 60min at 126°C; not in-line steam sterilizable

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(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: ≤ 10 mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 500 mL

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 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

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

This page may contain text that has been machine translated.