SGEPA25NB6

Millipore Express^® SHF, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm²

• Sinônimo(s): Millipore Express SHF Optiscale 25mm 0.2 μm NB
• Código UNSPSC: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Propriedades

• Materiais: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Nível de qualidade: 400
• conformidade reg.: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible
• linha de produto: OptiScale^® 25
• Características: hydrophilic
• fabricante/nome comercial: Millipore Express^®
• Parâmetros: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• técnica(s): sterile filtration: suitable
• Comprimento: 3.9 cm (1.52 in.)
• comprimento nominal do cartucho: 1.52 in. (39 mm)
• Diâmetro: 3.1 cm (1.2 in.)
• área de filtração: 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: Millipore Express^® SHF
• tamanho de poro: 0.2 μm
• conector: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)

Descrição

Descrição geral

Device Configuration: Capsule

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 installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer to OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Nota de preparo

Sterilization Method
1 autoclave cycle of 60 min @ 123 °C

This product was manufactured with a Millipore Express membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Nota de análise

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.

Informações legais

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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