KWL3A04FF3

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

Opticap^® XL 4, nominal pore size 0.2 μm, cartridge nominal length 4 in. (10 cm), filter diam. 4.9 in. (12.5 cm)

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: mixed cellulose esters (MCE) membrane; polyester support; polypropylene filter; polypropylene housing; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: FDA 21CFR177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible
• Produktlinie: Opticap^® XL 4
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Opticap^®
• Parameter: 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
• Methode(n): prefiltration: suitable
• Nennlänge Kartusche: 4 in. (10 cm)
• device L: 19.6 cm (7.7 in.)
• device size: 4 in.
• Filterdurchm.: 4.9 in. (12.5 cm)
• filter filtration area: 0.2 m²
• Durchm. Einlassanschluss: 3/4 in.
• inlet to outlet width: 19.6 cm (7.7 in.)
• Durchm. Auslassanschluss: 3/4 in.
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Milligard^® LPB
• Porengröße: 0.2 μm nominal pore size; 0.2 μm pore size
• Fitting: (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Capsule

Leistungsmerkmale und Vorteile

Single Layer

Verpackung

Double Easy-Open bag

Spezifikationen

Filter Grade: Low Protein Binding Milligard^® Media

Angaben zur Herstellung

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).

Hinweis zur Analyse

Gravimetric Extractables: ≤ 45 mg per capsule after a 2 L flush and 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

Sonstige Hinweise

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

Rechtliche Hinweise

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

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