CVGB02TP

Hydrophobic Durapore^® 0.22 µm, Cartridge

pore size 0.22 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Synonym(e): Durapore Cartridge Filter 20 in. 0.22 µm hydrophobic Code 0
• UNSPSC-Code: 23151806
• eCl@ss: 27293007

Eigenschaften

• Materialien: PVDF ; polypropylene ; polypropylene support; silicone seal
• Qualitätsniveau: 400
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: steam-in-place compatible
• Produktlinie: Durapore^®
• Leistungsmerkmale: hydrophobic
• Hersteller/Markenname: Durapore^®
• Parameter: ≤20 mL/min nitrogen diffusion at 1.7 bar (25 psig) and 23 °C (with water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• Methode(n): sterile filtration: suitable
• Länge: 20 in.
• Breite: 2.7 in.
• Nennlänge Kartusche: 20 in. (50 cm)
• Durchmesser: 6.9 cm (2.7 in.)
• Filtrationsfläche: 1.38 m²
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤40 mg/cartridge
• Matrix: Durapore^®
• Porengröße: 0.22 μm pore size
• Blasenpunkt: ≥1240 mbar (18 psig), nitrogen with 60/40% IPA/water at 23 °C
• Kartuschencode: Code 0 (2-222; O-rings)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Verpackung

Leicht zu öffnender Doppelbeutel

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

Sterilization Method
30 In-situ-Dampfsterilisationszyklen von 30 min bei 126 °C; 30 Autoklavenzyklen von 60 min bei 126 °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

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 24 hours in a 70/30% IPA/water mixture 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