CVBA02PK1

Vitipore^® II Kartuschenfilter

sterile; γ-irradiated, pore size 1.0 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Synonym(e): Vitipore II Cartridge Filter 20 in. 1.0μm Code 0
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: PVDF ; polypropylene ; polypropylene support; silicone seal
• 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: sterile; γ-irradiated
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Vitipore^®
• Parameter: ≤12.6 mL/min air diffusion at 480 mbar (7 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 109 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 25 °C (Reverse; intermittent); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Forward)
• Nennlänge Kartusche: 20 in. (50 cm)
• Durchmesser: 6.9 cm (2.7 in.)
• Filtrationsfläche: 1.56 m²
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤46 mg/cartridge
• Matrix: Vitipore^® II
• Porengröße: 1.0 μm nominal pore size; 1.0 μm pore size
• Aufnahme: sample type beer; sample type bottled water; sample type liquid; sample type beverage(s); sample type wine; sample type food(s)
• Blasenpunkt: ≥620 mbar (9 psig), air with water at 23 °C
• Kartuschencode: Code 0 (2-222; O-rings)

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

Sterilization Method
100 In-situ-Dampfsterilisationszyklen von 30 min bei 109 °C; 50 Desinfektionszyklen von 30 min mit maximal 80 °C heißem Wasser

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

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Rechtliche Hinweise

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

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