MPHL04GF2

Durapore^® 0,45 µm, Millipak^® Kapsel

sterile, Millipak^® 40

• Synonym(e): Sterile Millipak-40 Filter Unit 0.45 μm 3/4 in. TC/TC
• UNSPSC-Code: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Eigenschaften

• Materialien: PVDF membrane; PVDF vent cap; polycarbonate ; polycarbonate support
• Qualitätsniveau: 400
• Sterilität: irradiated; sterile
• Produktlinie: Millipak^® 40
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipak^®
• Parameter: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 20 L process volume; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 8.5 L/min flow rate at 2.45 bar (ΔP)
• Methode(n): bioburden reduction: suitable
• Filtrationsfläche: 200 cm²
• Durchm. Einlassanschluss: 3/4 in.
• Durchm. Auslassanschluss: 3/4 in.
• Verunreinigungen: ≤0.5 EU/mL (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤1.5 mg/device
• Matrix: Durapore^®
• Porengröße: 0.45 μm
• Blasenpunkt: ≥1790 mbar (26 psig), air with water at 23 °C
• Fitting: inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
• Versandbedingung: ambient

Beschreibung

Allgemeine Beschreibung

Device Configuration: Gamma Gold Capsule

Verpackung

Blister

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
3 Autoklavenzyklen von 90 min bei 123 °C; nicht inline dampfsterilisierbar

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 a 200 mL flush and 24 hours in water at controlled room temperature

Rechtliche Hinweise

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

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