CPGE03TP3

Millipore Express^® PHF, Cartridge

pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings), silicone seal

• Synonym(e): Millipore Express^® PHF Cartridge Filter 30 in. 0.2 µm Code 0 Silicone
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: polyethersulfone ; polypropylene ; 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: ≤90 mL/min air diffusion at 2.76 bar (40 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); 1.4 bar max. differential pressure (20 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 20 psi max. differential pressure (1.4 bar) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 80 °C (Forward); 5.0 psi max. differential pressure (340 mbar) at 135 °C (Forward); 5.5 bar max. differential pressure (80 psi) at 25 °C (Forward); 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• Methode(n): bioburden reduction: suitable
• Länge: 30 in.
• Breite: 2.7 in.
• Nennlänge Kartusche: 30 in. (75 cm)
• Durchmesser: 6.9 cm (2.7 in.)
• Filtrationsfläche: 1.62 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^® PHF
• Porengröße: 0.2 μm pore size
• Aufnahme: sample type liquid
• Kartuschencode: Code 0 (2-222; O-rings)

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Verpackung

Double Easy-Open bag

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
12 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 15 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

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥1 l Wasser

Bacterial Retention
Samples of membrane used in this filter 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 30 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