MCGB30S01

Hydrophobic Durapore^® 0.22 µm, Millidisk^® Cartridge

Millidisk^® 30, filtration area 1500 cm², hydrophobic

• Synonym(e): Millidisk Cartridge 30-stack 0.22 μm hydrophobic
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: PVDF ; polysulfone ; polysulfone support; silicone seal
• Qualitätsniveau: 400
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible; steam-in-place compatible
• Produktlinie: Millidisk^® 30
• Leistungsmerkmale: hydrophobic
• Hersteller/Markenname: Millidisk^®
• Parameter: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward)
• Methode(n): gas filtration: suitable
• Filtrationsfläche: 1500 cm²
• 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: ≤7.5 mg/device
• Matrix: Durapore^®
• Porengröße: 0.22 μm
• Aufnahme: sample type liquid
• Blasenpunkt: ≥1170 mbar (17.0 psig), nitrogen with 100% IPA at 23 °C
• Kartuschencode: not applicable

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Stack Design: 30 Stak

Verpackung

Leicht zu öffnender Beutel

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
5 In-situ-Dampfsterilisationszyklen von 30 min bei 135 °C; 5 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: using sterilized device 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

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