CW1904S03

Milligard^® 1.2 µm, Cartridge

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in. (7.1 cm)

• Kod UNSPSC: 23151806

Właściwości

• Materiały: polyester support; polypropylene device; silicone seal
• Poziom jakości: 400
• zgodność regionalna: meets EU 1935/2004/EC (alll component materials); meets FDA 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible; steam-in-place compatible
• linia produktu: Milligard^®
• Właściwości: hydrophilic
• producent / nazwa handlowa: Milligard^®
• Parametry: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• metody: prefiltration: suitable
• Długość: 40 in.
• Szerokość: 2.9 in.
• długość nominalna kartridża: 40 in. (100 cm)
• śr. filtra: 2.8 in. (7.1 cm)
• filter filtration area: 3.2 m²
• rozmiar filtra: 40 in.
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• macierz: Milligard^®
• wielkość porów: 1.2 μm nominal pore size; 1.2 μm pore size
• kod wkładu: Code 0

Opis

Opis ogólny

Cartridge Type: Liquid

Device Configuration: Cartridge

Filter Grade: Standard MILLIGARD^® Media

Cechy i korzyści

Format: Single Layer

Opakowanie

Double Easy-Open bag

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L  

Inne uwagi

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.

Informacje prawne

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

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

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