MFHL06ST3

Durapore^® 0.45 µm, Millipak^® Final Fill Capsule

Millipak^® Final Fill 60, sterile; γ-irradiated

• Code UNSPSC : 23151806

Propriétés

• Matériaux: polysulfone device; polysulfone support
• Niveau de qualité: 400
• Agence: meets EP 2.6.14; meets JP 4.01; meets USP 85
• Stérilité: irradiated; sterile; γ-irradiated
• Gamme de produits: Millipak^® Final Fill 60
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipak^®
• Paramètres: 1.5 L/min flow rate at 0.69 bar (ΔP); 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 60 L process volume; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• Technique(s): bioburden reduction: suitable
• filter filtration area: 300 cm²
• Impuretés: <0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
• Matrice: Durapore^®
• Dimension de pores: 0.45 μm pore size
• Point de bulle: ≥26 psi (1790 mbar), air with water
• Raccords: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

Description générale

Device Configuration: Gamma Gold Capsule

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

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 general guidelines section of user guide shipped with this product
• Storage Statement: Please refer user guide shipped with this product
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

Informations légales

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

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