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

Propiedades

• material: mixed cellulose esters (MCE) membrane; polyester support; polypropylene device; silicone seal
• Quality Level: 400
• reg. compliance: meets EU 1935/2004/EC (alll component materials); meets FDA 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Milligard^®
• feature: hydrophilic
• manufacturer/tradename: Milligard^®
• parameter: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• technique(s): prefiltration: suitable
• L: 20 in.
• W: 2.9 in.
• cartridge nominal length: 20 in. (50 cm)
• filter diam.: 2.8 in. (7.1 cm)
• filter filtration area: 1.6 m²
• filter size: 20 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Milligard^®
• pore size: 0.2 μm nominal pore size; 0.2 μm pore size
• cartridge code: Code 5

Descripción

General description

Cartridge Type: Liquid

Device Configuration: Cartridge

Filter Grade: Standard MILLIGARD^® Media

Features and Benefits

Format: Single Layer

Packaging

Double Easy-Open bag

Preparation Note

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).

Analysis Note

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

Other Notes

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.

Legal Information

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

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