CLVL72TP3

Durapore^® 0.1 µm, High Area, Cartridge

pore size 0.1 μm, cartridge nominal length 20 in. (50 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Synonym(e): Durapore^® II Cartridge Filter 20 in. 0.1 m Code 7
• UNSPSC-Code: 23151806
• eCl@ss: 27293007

Eigenschaften

• Materialien: PVDF
• 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; steam-in-place compatible
• Produktlinie: Durapore^®
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Durapore^® II
• Methode(n): sterile filtration: suitable
• Länge: 20 in.
• Breite: 2.7 in.
• Nennlänge Kartusche: 20 in. (50 cm)
• Filtrationsfläche: 2.2 m²
• Verunreinigungen: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤60 mg/cartridge
• Matrix: Durapore^® High Area
• Porengröße: 0.1 μm pore size
• Aufnahme: sample type liquid
• Kartuschencode: Code 7 (2-226; O-rings w/locking-tabs)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Sonstige Hinweise

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

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Angaben zur Herstellung

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

Bacterial Retention
Quantitative Rückhaltung von Brevundimonas diminuta bei einer Mindestbeaufschlagung von 1 x 10⁷ KBE/cm² unter Anwendung der ASTM^® F838-Methode.

Gravimetric Extractables: after a 1.5 L flush and 24 hours in water at controlled room temperature

Rechtliche Hinweise

ASTM is a registered trademark of American Society for Testing and Materials

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