CW19F2E0

Milligard^® 1.2 µm, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.8 in. (7.1 cm), Code F (double open end w/flat gaskets)

• UNSPSC Code: 23151806

Properties

• material: EPR seal; polyester support; polypropylene device
• Quality Level: 400
• reg. compliance: meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food); 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
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Milligard^®
• pore size: 1.2 μm nominal pore size; 1.2 μm pore size
• cartridge code: Code F (double open end w/flat gaskets)

Description

General description

Device Configuration: Cartridge
Cartridge Type: Liquid

Features and Benefits

Filter Grade: Standard MILLIGARD^® Media

Format: Single Layer

Packaging

Double Easy-Open Bag

Preparation Note

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: ≤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 ≥6 L  

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