CMP871TS1

Milligard^® PES 1.2/0.8 µm, Cartridge

pore size 1.2/0.8 μm, cartridge nominal length 10 in. (25 cm)

• Synonyme(s) : Milligard PES 10" 1.2/0.8 μm Cartridge
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: polyethersulfone membrane; polypropylene housing; polypropylene support; polypropylene vent cap; 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: EMPROVE^® Filter; Milligard^®
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Milligard^®
• Paramètres: 1.38 bar max. differential pressure (20 psid) at 25 °C (Reverse); 5.52 bar max. differential pressure (80 psid) at 4-25 °C (Forward)
• Technique(s): prefiltration: suitable
• Longueur: 317.5 mm (12.5 in.)
• Largeur: 2.7 in.
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diamètre: 69 mm (2.71 in.)
• Surface de filtration: 0.53 m²
• Impuretés: <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
• Matrice: Milligard^® PES
• pore size: 1.2/0.8 μm pore size
• Entrée: sample type liquid
• Code de la cartouche: Code 7

Description

Description générale

Device Configuration: Cartridge

Autres remarques

The product is manufactured in a facility which adheres to Good Manufacturing Practices. The manufacturing facility’s Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Standard.

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 MILLIGARD^® PES Membrane user guide
• Storage Statement: Please refer Filters with MILLIGARD^® PES Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Notes préparatoires

Sterilization Method
Autoclave wet 25x, 60 minute cycles at 128 °C. In-line steam (wet): 10 forward cycles, 30 min., 135 °C at ≤0.34 bar (5 psid) and 5 reverse cycles, 30 min., 135 °C at ≤0.07 bar (<1 psid)*.

*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.

This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Informations légales

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

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