CW0352S03

Milligard^® 0.2 µm nominal, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.8 in. (7.1 cm)

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: mixed cellulose esters (MCE) membrane; polyester support; polypropylene device; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets EU 1935/2004/EC (alll component materials); meets FDA 21 CFR 177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible; steam-in-place compatible
• Produktlinie: Milligard^®
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Milligard^®
• Parameter: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• Methode(n): prefiltration: suitable
• Länge: 20 in.
• Breite: 2.9 in.
• Nennlänge Kartusche: 20 in. (50 cm)
• Filterdurchm.: 2.8 in. (7.1 cm)
• filter filtration area: 1.6 m²
• Filtergröße: 20 in.
• Verunreinigungen: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Milligard^®
• Porengröße: 0.2 μm nominal pore size; 0.2 μm pore size
• Kartuschencode: Code 5

Beschreibung

Allgemeine Beschreibung

Cartridge Type: Liquid

Device Configuration: Cartridge

Filter Grade: Standard MILLIGARD^® Media

Leistungsmerkmale und Vorteile

Format: Single Layer

Verpackung

Double Easy-Open bag

Angaben zur Herstellung

Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Hinweis zur Analyse

Gravimetric Extractables: The extractables level was ≤50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.   

Sonstige Hinweise

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 installation and wetting sections of OPTISCALE^® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
• Storage Statement: Please refer Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Rechtliche Hinweise

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

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