MCGB10S02

Durapore^® 0,22 µm hidrófoba, Cartucho Millidisk^®

filtration area 500 cm², hydrophobic

• Sinónimos: Millidisk Cartridge 10-stack 0.22 m hydrophobic
• Código UNSPSC: 23151806
• eCl@ss: 32031690

Propiedades

• Materiales: PVDF ; polysulfone ; polysulfone support; silicone seal
• Nivel de calidad: 400
• esterilidad: non-sterile
• Compatibilidad de esterilización: autoclavable compatible; steam-in-place compatible
• Línea del producto: Millidisk^® 10
• Características: hydrophobic
• fabricante / nombre comercial: Millidisk^®
• Parámetros: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward)
• técnicas: gas filtration: suitable
• filtración área: 500 cm²
• impurezas: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíbles gravimétricos: ≤2.5 mg/device
• matriz: Durapore^®
• tamaño de poro: 0.22 μm
• entrada: sample type liquid
• punto de burbuja: ≥1170 mbar (17.0 psig), nitrogen with 100% IPA at 23 °C
• código del cartucho: not applicable

Descripción

Descripción general

Device Configuration: Cartridge

Stack Design: 10 Stak

Envase

Easy-Open bag

Otras 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 preparación

Sterilization Method
5 SIP cycles of 30 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C

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 análisis

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 24 hours in a 70/30% IPA/water mixture at controlled room temperature

Información legal

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

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

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