MFGB06ST3

Hidrófoba Durapore^® 0,22 µm, cápsula de llenado final Millipak^®

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

• Código UNSPSC: 23151806

Propiedades

• Materiales: polysulfone device; polysulfone support
• Nivel de calidad: 400
• Agency: meets EP 2.6.14; meets JP 4.01; meets USP 85
• esterilidad: irradiated; sterile; γ-irradiated
• Línea del producto: Millipak^® Final Fill 60
• Características: hydrophilic
• fabricante / nombre comercial: Millipak^®
• Parámetros: 1.51 L/min flow rate at 0.86 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)
• técnicas: sterile filtration: suitable
• filter filtration area: 300 cm²
• impurezas: <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)
• matriz: Durapore^®
• tamaño de poro: 0.22 μm pore size
• Adaptador: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descripción

Descripción general

Device Configuration: Gamma Gold Capsule

Envase

Double Easy-Open bag

Nota de preparación

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

Nota de análisis

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

Otras notas

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.

Información legal

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