CVEP01TS3

Millipore Express^® SHR, Cartridge

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

Properties

• material: polypropylene support; silicone seal
• 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: Millipore Express^®
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤33.3 mL/min air diffusion at 3.45 bar (50 psig) (in water); 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward); 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent); 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse); 340 mbar max. differential pressure (5 psi) at 135 °C (Forward); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward); 69 mbar max. differential pressure (<1.0 psi) at 135 °C (Reverse); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)
• technique(s): sterile filtration: suitable
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• filter diam.: 2.7 in. (6.9 cm)
• filter filtration area: 0.6 m²
• filter size: 10 in.
• 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^® SHR
• pore size: 0.1 μm
• bubble point: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• cartridge code: Code 0

Description

General description

Cartridge Type: Liquid

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C; 25 autoclave cycles of 60 min at 126 °C

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

TOC/Conductivity: After sterilization and a controlled water flush of 10 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

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