KGW9A3ZTT1

Polysep^™ II 2.0/1.2 µm nominal, Opticap^® XLT Capsule

Opticap^® XLT 30, inlet connection diam. 1.5 in., pore size 2.0/1.2 μm, cartridge nominal length 30 in. (75 cm)

• Synonym(e): Oticap XLT 30 Polysep II - 30" 2.0/1.2μm TC/TC 1pk
• UNSPSC-Code: 23151806
• eCl@ss: 32031610

Eigenschaften

• Materialien: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible
• Produktlinie: Opticap^® XLT 30
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Opticap^®
• Parameter: 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 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
• Länge: 34.3 in.
• Breite: 6.0 in.
• Nennlänge Kartusche: 30 in. (75 cm)
• Filtrationsfläche: 1.39 m²
• Durchm. Einlassanschluss: 1.5 in.
• Durchm. Auslassanschluss: 1.5 in.
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤435 mg/capsule
• Matrix: Polysep^™ II
• pore size: 2.0/1.2 μm nominal pore size; 2.0/1.2 μm pore size
• Aufnahme: sample type liquid
• Fitting: inlet sanitary flange; outlet sanitary flange; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filtereinheit

T-line/Gauge Port: T-line with 3/4 in. Gauge Port T-line side

Leistungsmerkmale und Vorteile

Format: Double Layer

Verpackung

Double Easy-Open bag

Sonstige Hinweise

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
• Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Angaben zur Herstellung

Sterilization Method
3 autoclave cycles of 30 min @ 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 21 CFR 210.3 (b) (6).

Hinweis zur Analyse

Gravimetric Extractables: after a 15 L flush and 24 hours in water at controlled room temperature

Rechtliche Hinweise

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

Polysep is a trademark of Sigma-Aldrich Co. LLC

Sicherheitshinweise

• Lagerklassenschlüssel: 11 - Combustible Solids
• WGK: WGK 2