CHVE71TS

Cartouche Millipore Express^® SHRP

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

• Synonyme(s) : Millipore Express^® SHR Cartridge Filter 10 in. 0.5/0.1 µm Code 7 Silicone
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: polyethersulfone ; polypropylene ; polypropylene support; polysulfone ; silicone seal
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible; steam-in-place compatible
• Gamme de produits: Millipore Express^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipore Express^®
• Paramètres: ≤27.1 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); 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)
• Technique(s): sterile filtration: suitable
• Longueur: 10 in.
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diamètre: 6.9 cm (2.7 in.)
• Surface de filtration: 0.48 m²
• Impuretés: ≤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^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• Entrée: sample type liquid
• Point de bulle: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• Code de la cartouche: Code 7

Description

Description générale

Device Configuration: Cartridge

Conditionnement

Double Easy-Open bag

Autres remarques

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.

Notes préparatoires

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).

Remarque sur l'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 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

Informations légales

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

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