SVSSA25NB6

Multimedia Durapore^® 0.5/0.2/0.22 µm, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm², pore size 0.5/0.2/0.22 μm

• Sinonimo/i: Multimedia Durapore^® 0.5 μm/0.2 μm/0.22 μm Optiscale 25mm NB
• Codice UNSPSC: 23151806
• eCl@ss: 32031610
• NACRES: NB.24

Proprietà

• Materiali: PVDF membrane; mixed cellulose esters (MCE) membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Livello qualitativo: 400
• Conformità normativa: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilità: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible
• Nome Commerciale: OptiScale^® 25
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: OptiScale^®
• Parametri: 4.0 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• tecniche: sterile filtration: suitable
• Lunghezza: 3.9 cm (1.52 in.)
• Diametro: 3.1 cm (1.2 in.)
• Superficie filtrante: 3.5 cm²
• Impurezze: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Multimedia Durapore^®
• pore size: 0.5/0.2/0.22 μm pore size
• input: sample type liquid
• Raccordi: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• Condizioni di spedizione: ambient

Descrizione

Descrizione generale

Device Configuration: Capsule

Altre note

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 sulla preparazione

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).

Risultati analitici

TOC/Conductivity
After sterilization and a controlled water flush of 35 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

Note legali

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

Informazioni sulla sicurezza

• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 3