MFGL04GF3

Durapore^®, 0,22 µm, Millipak^®-Kapsel für Endabfüllung

non-sterile (non-sterilized), Millipak^® Final Fill 40, pore size 0.22 μm

• Synonym(e): Millipak^® Final Fill 40
• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: PVDF membrane; polysulfone device; polysulfone support
• Qualitätsniveau: 400
• Agentur: certified by the ISO 9001:2015 (Quality Management Systems); meets requirements for EP 2.6.14; meets requirements for JP 4.01; meets requirements for USP 85
• Sterilität: irradiated; non-sterile (non-sterilized)
• Kompatibilität mit Sterilisationsverfahren: gamma compatible
• Produktlinie: Millipak^® Final Fill 40
• Leistungsmerkmale: hydrophilic
• Verpackung: bag of 3 × double easy-open bag
• Parameter: 1.0 L/min flow rate at 0.69 bar; 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 25 °C (Forward); 50 psi max. differential pressure (3.5 bar) at 25 °C (Forward); 60 psi max. differential pressure (4.1 bar) at 25 °C (Forward); 60 psi max. inlet pressure (4.1 bar) at 25 °C; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward); 80 psi max. inlet pressure (5.5 bar) at 25 °C
• Methode(n): sterile filtration: suitable
• Länge: 3.4 in.
• Breite: 3.0 in.
• Filtrationsfläche: 200 cm²
• Verunreinigungen: <0.25 EU/mL bacterial endotoxins (LAL test)
• Matrix: Durapore^®
• Porengröße: 0.22 μm pore size
• Blasenpunkt: ≥50 psi (3450 mbar), air with water at 23 °C
• Fitting: 3/4 in. inlet connection; 19 mm (3/4 in.) inlet/outlet connection (sanitary flange); (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Capsule

Verpackung

Double Easy-Open bag

Angaben zur Herstellung

Sterilization Method
Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 <nbsp/>°C. Devices can withstand a dose ? 40<nbsp/> kGy gamma exposure.

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), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections.

Hinweis zur Analyse

Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per AST F838 methodology.

Sonstige Hinweise

Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.

Rechtliche Hinweise

ATCC is a registered trademark of American Type Culture Collection

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

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