KN03A10FF1

Opticap^® XL Kapselfilter

pore size 0.3 μm, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA 21 CFR 177-182 (all component materials)
• Hersteller/Markenname: Opticap^®
• Parameter: 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 25 °C; 80 psig max. inlet pressure
• Nennlänge Kartusche: 10 in. (25 cm)
• device size: 10 in.
• filter L: 13.2 in. (33.5 cm)
• Filterdurchm.: 4.2 in. (10.7 cm)
• filter filtration area: 0.42 m²
• Durchm. Einlassanschluss: 3/4 in. , sanitary flange
• inlet to outlet width: 33.5 cm (13.2 in.)
• Verunreinigungen: ≤0.5 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• Matrix: Polygard^®-CN
• Porengröße: 0.3 μm pore size
• Fitting: inlet/outlet connection for 19 mm (3/4 in.) sanitary flange

Beschreibung

Allgemeine Beschreibung

Cartridge Type: Liquid

Device Configuration: Capsule

Leistungsmerkmale und Vorteile

Format: Single Layer

Verpackung

Double Easy-Open bag

Angaben zur Herstellung

Sterilization Method:
3 autoclave cycles of 30min at 126°C; not in-line steam sterilizable

Hinweis zur Analyse

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 ≥5L

Sonstige Hinweise

Directions for Use:

• Organism Retention: Microorganism reduction
• Mode of Action: Filtration (size exclusion)
• Applicaiton: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer to 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

Rechtliche Hinweise

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

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