CVEP71TS3

Millipore Express^® SHR 0.1µm Cartridge 10

Code 7 Silicone, Autoclavable and SIP

• Synonym(e): Millipore Express^® SHR Cartridge Filter 10 in. 0.1 µm Code 7 Silicone
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Produktname: Millipore Express^® SHR, Cartridge, pore size 0.1 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal
• Materialien: polyethersulfone ; polypropylene ; polypropylene support; polysulfone ; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA Indirect Food Additive requirements cited in 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: ≤33.3 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); <1.0 psi max. differential pressure (69 mbar) at 135 °C (Reverse); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 100 psi max. differential pressure (6.9 bar) at 25 °C (Forward); 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 80 °C (Forward); 30 psi max. differential pressure (2.1 bar) at 25 °C (Reverse); 5.0 psi max. differential pressure (340 mbar) at 135 °C (Forward); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
• Methode(n): sterile filtration: suitable
• Länge: 10 in.
• Breite: 2.7 in.
• Nennlänge Kartusche: 10 in. (25 cm)
• Durchmesser: 6.9 cm (2.7 in.)
• Filtrationsfläche: 0.6 m²
• 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 nominal pore size; 0.1 μm pore size
• Aufnahme: sample type liquid
• Blasenpunkt: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• Kartuschencode: Code 7

Beschreibung

Allgemeine Beschreibung

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 @ 135 °C; 25 autoclave cycles of 60 min @ 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

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 10 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

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