MPVL20CF3

Millipak^® 200 Capsule Media: Durapore^® 0.1 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange

• Synonym(e): Gamma Compatible Millipak -200 Filter Unit 0.1 μm 3/4 in. TC/TC, Durapore^® 0.1 µm, Millipak^® Capsule
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Durapore^® 0,1 µm, Millipak^® Kapsel, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange
• Quality Level: 400
• material: PVDF , PVDF vent cap, polycarbonate , polycarbonate support
• sterility: irradiated, non-sterile
• sterilization compatibility: gamma compatible
• product line: Millipak^® 200
• feature: gamma compatible, hydrophilic
• manufacturer/tradename: 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), 100 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)
• technique(s): sterile filtration: suitable
• L: 6.0 in.
• W: 3.0 in.
• diam.: 7.6 cm (3.0 in.)
• filtration area: 1000 cm²
• inlet connection diam.: 3/4 in.
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤5 mg/device
• matrix: Durapore^®
• pore size: 0.1 μm
• bubble point: ≥4830 mbar (70 psig), air with water at 23 °C
• fitting: inlet sanitary flange, outlet sanitary flange, (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Beschreibung

General description

Device Configuration: Filtereinheit

Packaging

Leicht zu öffnender Doppelbeutel

Preparation Note

Sterilization Method
3 Autoklavenzyklen von 90 min bei 123 °C; gammabeständig bis zu 45 Kilogray (4,5 Megarad); 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).

Analysis Note

Bacterial Retention
Quantitative Rückhaltung von Brevundimonas diminuta bei einer Mindestbeaufschlagung von 1 x 10⁷ KBE/cm² unter Anwendung der ASTM^® F838-Methode.

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

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

Other Notes

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.

Legal Information

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

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

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