CVEP73TE3

Millipore Express^® SHR, Cartridge

cartridge nominal length 30 in. (75 cm), filter diam. 2.7 in. (6.9 cm), Code 7

• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: EPDM rubber seal; polypropylene support
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA 21 CFR 177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible; steam-in-place compatible
• Produktlinie: Millipore Express^®
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipore Express^®
• Parameter: ≤99.9 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)
• Methode(n): sterile filtration: suitable
• Länge: 30 in.
• Breite: 2.7 in.
• Nennlänge Kartusche: 30 in. (75 cm)
• Filterdurchm.: 2.7 in. (6.9 cm)
• filter filtration area: 1.8 m²
• Filtergröße: 30 in.
• Verunreinigungen: ≤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
• Porengröße: 0.1 μm pore size
• Blasenpunkt: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• Kartuschencode: Code 7

Beschreibung

Allgemeine Beschreibung

Cartridge Type: Liquid

Device Configuration: Cartridge

Verpackung

Double Easy-Open bag

Angaben zur Herstellung

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).

Hinweis zur Analyse

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

TOC/Conductivity: After sterilization and a controlled water flush of 30 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.

Sonstige Hinweise

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.

Rechtliche Hinweise

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

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