MFHL06ST3

Durapore^®, 0,45 µm, Millipak^®-Kapsel für Endabfüllung

Millipak^® Final Fill 60, sterile; γ-irradiated

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: polysulfone device; polysulfone support
• Qualitätsniveau: 400
• Agentur: meets EP 2.6.14; meets JP 4.01; meets USP 85
• Sterilität: irradiated; sterile; γ-irradiated
• Produktlinie: Millipak^® Final Fill 60
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipak^®
• Parameter: 1.5 L/min flow rate at 0.69 bar (ΔP); 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 60 L process volume; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• Methode(n): bioburden reduction: suitable
• filter filtration area: 300 cm²
• Verunreinigungen: <0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
• Matrix: Durapore^®
• Porengröße: 0.45 μm pore size
• Blasenpunkt: ≥26 psi (1790 mbar), air with water
• Fitting: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Gamma Gold 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  °C. Devices can withstand a dose ≤40  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

Sonstige Hinweise

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 general guidelines section of user guide shipped with this product
• Storage Statement: Please refer user guide shipped with this product
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

Rechtliche Hinweise

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

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