CGW1M4S03

Polysep^™ II 1.0/0.2/0.1 µm nominal, Cartridge

pore size 1.0/0.2/0.1 μm, cartridge nominal length 10 cm (4 in.), filter diam. 7.1 cm (2.8 in.)

• Código UNSPSC: 23151806

Propriedades

• Materiais: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene prefilter; polypropylene support; silicone seal
• Nível de qualidade: 400
• conformidade reg.: meets FDA 21 CFR 177-182 (all component materials)
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible; steam-in-place compatible
• linha de produto: Polysep^™
• Características: hydrophilic
• fabricante/nome comercial: Polysep^™
• Parâmetros: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• técnica(s): prefiltration: suitable
• Comprimento: 4 in.
• Largura: 2.7 in.
• comprimento nominal do cartucho: 10 cm (4 in.)
• diâmetro do filtro: 7.1 cm (2.8 in.)
• filter filtration area: 0.17 m²
• Impurezas: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction ); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction )
• matriz: Polysep^™ II
• pore size: 1.0/0.2/0.1 μm nominal pore size; 1.0/0.2/0.1 μm pore size
• código do cartucho: Code M

Descrição

Descrição geral

Device Configuration: Cartridge

Características e benefícios

Triple Layer

Embalagem

Double Easy-Open bag

Nota de preparo

Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C

Nota de análise

Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 2 L

Outras notas

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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
• Storage Statement: Please refer Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

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

Informações legais

Polysep is a trademark of Sigma-Aldrich Co. LLC