CVGL03TP3

Durapore^® 0.22 µm, Cartridge

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings)

• Synonym(e): Durapore Cartridge Filter 30 in. 0.22 μm Code 0
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: PVDF ; polypropylene ; polypropylene support; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food); 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^®; EMPROVE^® Filter
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Durapore^®
• Parameter: ≤40 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in 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); 50 L/min flow rate at 460 mbar (ΔP)
• Methode(n): sterile filtration: suitable
• Länge: 30 in.
• Breite: 2.7 in.
• Nennlänge Kartusche: 30 in. (75 cm)
• Durchmesser: 6.9 cm (2.7 in.)
• Filtrationsfläche: 2.07 m²
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Durapore^®
• Porengröße: 0.22 μm pore size
• Aufnahme: sample type liquid
• Blasenpunkt: ≥3450 mbar (50 psig), air with 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 135 °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.

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥3 l Wasser

TOC/Conductivity
After sterilization and a controlled water flush of 16.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

Rechtliche Hinweise

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

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

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