CHGE71HE3

Millipore Express^® SHC High Area 0.5/0.2µm Cartridge 10

Code 7 EPDM, Autoclavable and SIP

• UNSPSC Code: 23151806

Properties

• Product Name: Millipore Express^® SHC High Area, Cartridge, cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm), Code 7
• material: EPDM rubber seal; polyethersulfone device; polypropylene device; polypropylene support
• Quality Level: 400
• 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 7

Description

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

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

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.

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