CW1974S03

Milligard^® 1.2 µm, Cartridge

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in. (7.1 cm)

• Code UNSPSC : 23151806

Propriétés

• Matériaux: polyester support; polypropylene device; silicone seal
• Niveau de qualité: 400
• Conformité réglementaire: meets EU 1935/2004/EC (alll component materials); meets FDA 21 CFR 177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible; steam-in-place compatible
• Gamme de produits: Milligard^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Milligard^®
• Paramètres: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• Technique(s): prefiltration: suitable
• Longueur: 40 in.
• Largeur: 2.9 in.
• Longueur nominale des cartouches: 40 in. (100 cm)
• Diam. du filtre: 2.8 in. (7.1 cm)
• filter filtration area: 3.2 m²
• Taille du filtre: 40 in.
• Impuretés: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Milligard^®
• Dimension de pores: 1.2 μm nominal pore size; 1.2 μm pore size
• Code de la cartouche: Code 7

Description

Description générale

Cartridge Type: Liquid

Device Configuration: Cartridge

Filter Grade: Standard MILLIGARD^® Media

Caractéristiques et avantages

Format: Single Layer

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Remarque sur l'analyse

Gravimetric Extractables: The extractables level was ≤50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L  

Autres remarques

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 installation and wetting sections of OPTISCALE^® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
• Storage Statement: Please refer Mixed cellulose esters Tech Brief
• 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.

Informations légales

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

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