CHGE01HS

MILLIPORE EXPRESS^® SHC High Area Cartridge

cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm)

• UNSPSC Code: 23151806

Eigenschaften

• material: polyethersulfone device, polypropylene device, polypropylene support, silicone seal
• reg. compliance: meets FDA 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: EMPROVE^® Filter, Millipore Express^®
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤56.4 mL/min air diffusion at 2.75 bar (40 psig) (in water), 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward ), 1700 mbar max. inlet pressure (25 psi) at 80 °C (Forward ), 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse), 2100 mbar max. inlet pressure (30 psi) at 25 °C (Reverse), 340 mbar max. differential pressure (5 psi) at 135 °C (Forward ), 340 mbar max. inlet pressure (5 psi) at 135 °C (Forward ), 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse), 69 mbar max. inlet pressure (1 psi) at 135 °C (Reverse), 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward ), 6900 mbar max. inlet pressure (100 psi) at 25 °C (Forward )
• technique(s): sterile filtration: suitable
• L: 10 in.
• W: 2.8 in.
• cartridge nominal length: 10 in. (25 cm)
• filter diam.: 2.7 in. (6.9 cm)
• filter filtration area: 1.0 m²
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHC High Area
• pore size: 0.5/0.2 μm pore size
• bubble point: ≥4000 mbar (58 psig), air with water
• cartridge code: Code 0

Beschreibung

General description

Device Configuration: Cartridge
Cartridge Type: Liquid

Packaging

Double Easy-Open Bag

Preparation Note

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

Analysis Note

TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.



Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• 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

ASTM is a registered trademark of American Society for Testing and Materials

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany