MFHL06GT3

Durapore^® 0.45 µm, Millipak^® Final Fill Capsule

Millipak^® Final Fill 60

• Código UNSPSC: 23151806

Propriedades

• Materiais: polysulfone device; polysulfone support
• Nível de qualidade: 400
• Agency: meets EP 2.6.14; meets JP 4.01; meets USP 85
• esterilidade: irradiated; non-sterile
• Compatibilidade de esterilização: gamma compatible
• linha de produto: Millipak^® Final Fill 60
• Características: hydrophilic
• fabricante/nome comercial: Millipak^®
• Parâmetros: 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)
• técnica(s): bioburden reduction: suitable
• Comprimento: 4.3 in.
• Largura: 3.0 in.
• Área de filtração do filtro: 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^®
• tamanho de poro: 0.45 μm pore size
• ponto de bolha: ≥26 psi (1790 mbar), air with water
• conector: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descrição

Descrição geral

Device Configuration: Capsule

Embalagem

Double Easy-Open bag

Nota de preparo

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

Outras 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.

Informações legais

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

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