CHVE71TS3

Millipore Express^® SHRP, Kartusche

pore size 0.5/0.1 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal

• Synonym(e): Millipore Express SHR Cartridge Filter 10 in. 0.5/0.1 μm Code 7 Silicone
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• 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: ≤27.1 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C ( in water); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 100 psi max. differential pressure (6.9 bar) at 25 °C (forward); 15 psi max. differential pressure (1.0 bar) at 135 °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); 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: 0.48 m²
• Verunreinigungen: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Millipore Express^® SHR (w/Prefilter)
• pore size: 0.5/0.1 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: Filterelement

Verpackung

Leicht zu öffnender Doppelbeutel

Sonstige Hinweise

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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.

Angaben zur Herstellung

Sterilization Method
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C, or 3 forward cycles, 30 min., 135 °C at ≤ 1000 mbar (15 psid); 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
Quantitative Rückhaltung von Brevundimonas diminuta bei einer Mindestbeaufschlagung von 1 x 10⁷ KBE/cm² unter Anwendung der ASTM^® F838-Methode.

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥2 l Wasser

TOC/Conductivity
After sterilization and a controlled water flush of 20 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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