KWL3A10FF1

Milligard^® LPB 0.2 µm nominal, Opticap^® XL Capsule

nominal pore size 0.2 μm, Opticap^® XL 10, cartridge nominal length 10 in. (25 cm), filter diam. 5.7 in. (14.5 cm)

• Kod UNSPSC: 23151806

Właściwości

• Materiały: mixed cellulose esters (MCE) membrane; polyester support; polypropylene filter; polypropylene housing; 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 10
• Właściwości: hydrophilic
• producent / nazwa handlowa: Opticap^®
• Parametry: 1 bar max. inlet pressure (15 psi) at 80 °C; 2.75 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; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• metody: prefiltration: suitable
• długość nominalna kartridża: 10 in. (25 cm)
• device L: 33.5 cm (13.2 in.)
• device size: 10 in.
• śr. filtra: 5.7 in. (14.5 cm)
• filter filtration area: 0.8 m²
• śr. przyłącza doprowadzającego: 3/4 in.
• inlet to outlet width: 33.5 cm (13.2 in.)
• śr. przyłącza odprowadzającego: 3/4 in.
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• macierz: Milligard^® LPB
• wielkość porów: 0.2 μm nominal pore size; 0.2 μm pore size
• dopasowywanie: (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Opis

Opis ogólny

Device Configuration: Capsule

Cechy i korzyści

Single Layer

Opakowanie

Double Easy-Open bag

Charakterystyka techniczna

Filter Grade: Low Protein Binding Milligard^® Media

Uwaga dotycząca przygotowania

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Komentarz do analizy

Gravimetric Extractables: ≤ 105 mg per capsule after a 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 ≥ 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 installation section of Opticap^® XL Capsules and Opticap^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Informacje prawne

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

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

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