CGW104S03

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

pore size 1.0/0.2/0.1 μm, cartridge nominal length 100 cm (40 in.), filter diam. 7.1 cm (2.8 in.)

• Codice UNSPSC: 23151806

Proprietà

• Materiali: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene prefilter; silicone seal
• Livello qualitativo: 400
• Conformità normativa: meets FDA 21 CFR 177-182 (all component materials)
• Sterilità: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible; steam-in-place compatible
• Nome Commerciale: Polysep^™
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Polysep^™
• Parametri: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• tecniche: prefiltration: suitable
• Lunghezza: 40 in.
• Larghezza: 2.7 in.
• Lunghezza nominale della cartuccia: 100 cm (40 in.)
• Diam. filtro: 7.1 cm (2.8 in.)
• filter filtration area: 1.68 m²
• Impurezze: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction ); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction )
• Matrice: Polysep^™ II
• pore size: 1.0/0.2/0.1 μm nominal pore size; 1.0/0.2/0.1 μm pore size
• Codice cartuccia: Code 0

Descrizione

Descrizione generale

Device Configuration: Cartridge

Caratteristiche e vantaggi

Triple Layer

Confezionamento

Double Easy-Open bag

Nota sulla preparazione

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

Risultati analitici

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 ≥ 20 L

Altre note

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.

Note legali

Polysep is a trademark of Sigma-Aldrich Co. LLC