MCSL40S01

Durapore^®, 5,0 µm, Millidisk^®-Kartusche

Millidisk^® 40, filtration area 2000 cm², hydrophilic

• Synonym(e): Millidisk Cartridge 40-stack 5.0 μm Hydrophilic
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: PVDF ; polysulfone ; polysulfone support; silicone seal
• Qualitätsniveau: 400
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible; steam-in-place compatible
• Produktlinie: Millidisk^® 40
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millidisk^®
• Parameter: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward); 75 L/min flow rate at 1.75 bar (ΔP)
• Methode(n): prefiltration: suitable
• Filtrationsfläche: 2000 cm²
• 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: ≤10 mg/device
• Matrix: Durapore^®
• Porengröße: 5.0 μm pore size
• Aufnahme: sample type liquid
• Blasenpunkt: ≥138 mbar (2 psig), air with water at 23 °C
• Kartuschencode: not applicable

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Stack Design: 40 Stak

Verpackung

Leicht zu öffnender Doppelbeutel

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Angaben zur Herstellung

Sterilization Method
5 In-situ-Dampfsterilisationszyklen von 60 min bei 135 °C; 5 Autoklavenzyklen von 60 min bei 126 °C

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

Hinweis zur Analyse

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥200 ml Wasser

Gravimetric Extractables: using sterilized device after 24 hours in water at controlled room temperature

Rechtliche Hinweise

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

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