SMP8A25NB6

Milligard^® PES 1.2/0.8 µm, OptiScale^® Capsule

filtration area 3.5 cm², OptiScale^® 25, pore size 1.2/0.8 μm

• Sinônimo(s): OptiScale 25 Milligard PES 1.2/0.8 μm NB
• Código UNSPSC: 23151806

Propriedades

• Materiais: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Nível de qualidade: 400
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible
• linha de produto: OptiScale^® 25
• Características: hydrophilic
• fabricante/nome comercial: OptiScale^®
• Parâmetros: 0 bar max. differential pressure (Reverse); 4.14 bar max. differential pressure (60 psi) at 25 °C (Forward); 60 psi max. inlet pressure (4.1 bar)
• técnica(s): prefiltration: suitable
• Comprimento: 3.9 cm (1.52 in.)
• Largura: 1.21 in.
• Diâmetro: 3.1 cm (1.2 in.)
• área de filtração: 3.5 cm²
• Impurezas: <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
• matriz: Milligard^® PES
• pore size: 1.2/0.8 μm pore size
• conector: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• código do cartucho: not applicable

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: 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 preparo

Devices tested and meet requirements of USP <78> for large volume parenterals.

Sterilization Method
Capsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.

Nota de análise

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

Informações legais

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

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

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