CHGE71TS

Cartucce Millipore Express^® SHC

pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm), Code 7, silicone seal

• Sinonimo/i: Millipore Express^® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone
• Codice UNSPSC: 23151806
• eCl@ss: 32031690

Proprietà

• Materiali: polyethersulfone ; polypropylene ; polypropylene support; polysulfone ; silicone seal
• Livello qualitativo: 400
• Conformità normativa: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilità: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible; steam-in-place compatible
• Nome Commerciale: EMPROVE^® Filter; Millipore Express^®
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Millipore Express^®
• Parametri: ≤28.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water); 0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 1700 bar max. differential pressure (25 psi) at 80 °C (Forward); 2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse); 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse); 340 mbar max. differential pressure (5 psi) at 135 °C (Forward); 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward); 7 bar max. inlet pressure (100 psi) at 25 °C (Forward)
• tecniche: sterile filtration: suitable
• Lunghezza: 10 in.
• Larghezza: 2.7 in.
• Lunghezza nominale della cartuccia: 10 in. (25 cm)
• Diametro: 6.9 cm (2.7 in.)
• Superficie filtrante: 0.49 m²
• Impurezze: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• input: sample type liquid
• Punto di bolla: ≥4000 mbar (58 psig), air with water at 23 °C
• Codice cartuccia: Code 7

Descrizione

Descrizione generale

Device Configuration: Cartridge

Confezionamento

Double Easy-Open bag

Altre note

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

Nota sulla preparazione

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).

Risultati analitici

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 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.

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

Note legali

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

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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