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Millipore Express^® SHR High Area with prefilter 0.5/0.1µm, Opticap^® XLT 30 Capsule

Fittings 1-1/2 in. TC, Gamma Compatible

• UNSPSC-Code: 23151806

Eigenschaften

• Produktbezeichnung: Millipore Express^® SHRP High Area, Opticap^® XLT Capsule, Opticap^® XLT 30, cartridge nominal length 30 in. (75 cm), filter diam. 4.2 in. (10.7 cm)
• Materialien: polyester support; polypropylene housing; silicone seal; vent cap (gamma stable polypropylene)
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA 21 CFR 177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: gamma compatible
• Produktlinie: Opticap^® XLT 30
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipore Express^®
• Parameter: ≤162.6 mL/min air diffusion at 3.45 bar (50 psig) (in water); 1 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet pressure; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psig max. inlet pressure
• Methode(n): sterile filtration: suitable
• Länge: 34.3 in.
• Breite: 7.8 in.
• Nennlänge Kartusche: 30 in. (75 cm)
• Filterdurchm.: 4.2 in. (10.7 cm)
• Filtergröße: 30 in.
• Filtrationsfläche: 3.0 m²
• Verunreinigungen: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
• Matrix: Millipore Express^® SHR ((w/Prefilter High Area))
• pore size: 0.5/0.1 μm pore size
• Blasenpunkt: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• Fitting: 1/4 in. drain/vent connection ( hose barb with double o-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
• Anwendung(en): filtration

Beschreibung

Allgemeine Beschreibung

Device Configuration: Capsule

Leistungsmerkmale und Vorteile

T-line/Gauge Port: T-line

Verpackung

Double Easy-Open bag

Angaben zur Herstellung

Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 123 °C; not in-line steam sterilizable

This product was manufactured with a MILLIPORE EXPRESS^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Hinweis zur Analyse

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L

TOC/Conductivity: After sterilization and a controlled water flush of 60 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Rechtliche Hinweise

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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