K003A05TT1

Opticap^® XL Capsule Filter

pore size 0.3 μm, cartridge nominal length 5 in. (12.5 cm), filter diam. 4.2 in. (10.7 cm)

• Kod UNSPSC: 23151806

Właściwości

• Materiały: polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Poziom jakości: 400
• zgodność regionalna: meets FDA 21 CFR 177-182 (all component materials)
• producent / nazwa handlowa: Opticap^®
• Parametry: max. inlet temp. at 25 °C; 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• długość nominalna kartridża: 5 in. (12.5 cm)
• device size: 5 in.
• filter L: 8.5 in. (21.6 cm)
• śr. filtra: 4.2 in. (10.7 cm)
• śr. przyłącza doprowadzającego: 1-1/2 in. , hose barb
• inlet to outlet width: 21.6 cm (8.5 in.)
• zanieczyszczenia: ≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• macierz: Clarigard^®
• wielkość porów: 0.3 μm pore size
• dopasowywanie: inlet/outlet connection for 38 mm (1 1/2 in.) sanitary flange

Opis

Opis ogólny

Cartridge Type: Liquid

Device Configuration: Capsule

Opakowanie

Double Easy-Open bag

Uwaga dotycząca przygotowania

Sterilization Method:
3 autoclave cycles of 30min at 126°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: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2L

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

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

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

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