LAHL04TP6

Durapore^® 0.45 µm with Prefilter, Optiseal^® Cartridge

OptiSeal^® 4 in., filtration area 0.18 m², matrix Durapore^® (w/Prefilter)

• Synonym(e): Optiseal Durapore Cartridge Filter 0.45 μm with prefilter
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: PVDF ; mixed cellulose esters (MCE) prefilter; polypropylene ; polypropylene support; silicone seal
• 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: OptiSeal^® 4 in.
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: OptiSeal^®
• Parameter: ≤4 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. differential pressure (50 psid) at 80 °C (Forward); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward); 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): bioburden reduction: suitable
• Länge: 4 in.
• Nennlänge Kartusche: 4 in. (10 cm)
• Filtrationsfläche: 0.18 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: ≤15 mg/cartridge
• Matrix: Durapore^® (w/Prefilter)
• Porengröße: 0.45 μm
• Aufnahme: sample type liquid
• Blasenpunkt: ≥1930 mbar (28 psig), air with water at 23 °C
• Kartuschencode: not applicable

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
10 Autoklaven- oder In-situ-Dampfsterilisationszyklen von 30 min bei 121 °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

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥500 ml Wasser

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

Rechtliche Hinweise

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

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

Sicherheitshinweise

• Lagerklassenschlüssel: 4.1B - Flammable solid hazardous materials
• WGK: WGK 3