SVHLA25NB6

Durapore^® 0.45 µm with Prefilter, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm², pore size 0.5/0.45 μm

• Synonym(e): Durapore^® 0.45 μm w/ pre-filter Optiscale 25mm NB
• UNSPSC-Code: 23151806
• eCl@ss: 32031610
• NACRES: NB.24

Eigenschaften

• Materialien: PVDF membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible
• Produktlinie: OptiScale^® 25
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: OptiScale^®
• Parameter: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• Methode(n): bioburden reduction: suitable
• Länge: 3.9 cm (1.52 in.)
• Breite: 1.21 in.
• Durchmesser: 3.1 cm (1.2 in.)
• Filtrationsfläche: 3.5 cm²
• Verunreinigungen: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Durapore^®
• pore size: 0.5/0.45 μm pore size
• Aufnahme: sample type liquid
• Fitting: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• Versandbedingung: ambient

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filtereinheit

Sonstige Hinweise

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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.

Angaben zur Herstellung

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).

Hinweis zur Analyse

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.

Rechtliche Hinweise

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

Sicherheitshinweise

• Lagerklassenschlüssel: 10-13 - German Storage Class 10 to 13