MFVL06ST3

Durapore^® 0.1 µm, Millipak^® Final Fill Capsule

Millipak^® Final Fill 60

• 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: sterile; irradiated
• Produktlinie: Millipak^® Final Fill 60
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipak^®
• Parameter: 0.51 L/min flow rate at 0.69 bar (Δ P); 0.7 bar max. differential pressure (10 psi) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 25 °C; 5.5 bar max. differential pressure (80 psi) at 25 °C (Forward)
• Methode(n): sterile filtration: suitable
• filter filtration area: 300 cm²
• Durchm. Einlassanschluss: 1.5 in. , sanitary flange
• Durchm. Auslassanschluss: 1.5 in.
• Verunreinigungen: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Durapore^®
• Porengröße: 0.1 μm pore size
• Blasenpunkt: ≥4830 mbar (70 psi), air with water
• Fitting: (38 mm (1½ in.) Sanitary Flange Inlet and Outlet)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Gamma Gold Capsule

Verpackung

Double Easy-Open Bag

Angaben zur Herstellung

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

Bacterial Retention: Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

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

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

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