SPHLA25NB6

Durapore^® 0.45 µm, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm²

• Sinónimos: Durapore^® 0.45 μm Optiscale 25mm NB
• Código UNSPSC: 23151806
• eCl@ss: 32031610
• NACRES: NB.24

Propiedades

• Materiales: PVDF membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Nivel de calidad: 400
• cumplimiento norm.: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• esterilidad: non-sterile
• Compatibilidad de esterilización: autoclavable compatible
• Línea del producto: OptiScale^® 25
• Características: hydrophilic
• fabricante / nombre comercial: OptiScale^®
• Parámetros: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• técnicas: bioburden reduction: suitable
• Longitud: 3.9 cm (1.52 in.)
• Anchura: 1.21 in.
• Diámetro: 3.1 cm (1.2 in.)
• filtración área: 3.5 cm²
• impurezas: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matriz: Durapore^®
• tamaño de poro: 0.45 μm
• entrada: sample type liquid
• Adaptador: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• Condiciones de envío: ambient

Descripción

Descripción general

Device Configuration: Capsule

Otras notas

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

Directions for Use

• Organism Retention: Bacterial
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Nota de preparación

Sterilization Method
1 autoclave cycle of 60 min @ 123 °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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

Información legal

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

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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

Información de seguridad

• Código de clase de almacenamiento: 10-13 - German Storage Class 10 to 13