CVEP72TF3

Millipore Express^® SHR 0.1µm Cartridge 20

Code 7 Fluorocarbon, Autoclavable and SIP

• Kod UNSPSC: 23151806

Właściwości

• Nazwa produktu: Millipore Express^® SHR, Cartridge, cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 7
• Materiały: polypropylene support; seal (Fluorocarbon rubber)
• Poziom jakości: 400
• zgodność regionalna: meets FDA 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible; steam-in-place compatible
• linia produktu: Millipore Express^®
• Właściwości: hydrophilic
• producent / nazwa handlowa: Millipore Express^®
• Parametry: ≤66.6 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)
• metody: sterile filtration: suitable
• Długość: 20 in.
• Szerokość: 2.7 in.
• długość nominalna kartridża: 20 in. (50 cm)
• śr. filtra: 2.7 in. (6.9 cm)
• Powierzchnia filtracyjna filtra: 1.2 m²
• rozmiar filtra: 20 in.
• zanieczyszczenia: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matryca: Millipore Express^® SHR
• wielkość porów: 0.1 μm pore size
• punkt pęcherzykowania: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• kod wkładu: Code 7

Opis

Opis ogólny

Cartridge Type: Liquid

Device Configuration: Cartridge

Opakowanie

Double Easy-Open bag

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

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.

Inne uwagi

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.

Informacje prawne

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

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

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