MPVL2GCA3

Cápsula Durapore^® 0,1 µm, Millipak^®

Millipak^® 200, sterile

• Sinônimo(s): Sterile Millipak-200 Filter Unit 0.1 μm 9/16 in. HB/HB
• Código UNSPSC: 23151806

Propriedades

• Materiais: PVDF ; PVDF vent cap; polycarbonate ; polycarbonate support
• Nível de qualidade: 400
• esterilidade: irradiated; sterile
• linha de produto: Millipak^® 200
• Características: hydrophilic
• fabricante/nome comercial: Millipak^®
• Parâmetros: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 100 L process volume; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 8.5 L/min flow rate at 2.45 bar (ΔP)
• técnica(s): sterile filtration: suitable
• área de filtração: 1000 cm²
• diâm. conexão de entrada: 9/16 in.
• diam. conexão de saída: 9/16 in.
• Impurezas: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíveis gravimétricos: ≤5 mg/device
• matriz: Durapore^®
• tamanho de poro: 0.1 μm
• ponto de bolha: ≥4830 mbar (70 psig), air with water at 23 °C
• conector: inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

Descrição

Descrição geral

Device Configuration: Gamma Gold Capsule

Embalagem

Double Easy-Open bag

Outras notas

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Nota de preparo

Sterilization Method
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable

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).

Nota de análise

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

Informações legais

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

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

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