MFGL10SL3

Durapore^® 0,22 µm, Capsule de remplissage final Millipak^®

Millipak^® Final Fill 100, 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 100
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipak^®
• Paramètres: 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 100 L process volume; 3.81 L/min flow rate at 1.1 bar (ΔP); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• Technique(s): sterile filtration: suitable
• filter filtration area: 500 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: 0.22 μm pore size
• Point de bulle: ≥50 psi (3450 mbar), air with water
• Raccords: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb 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

Remarque sur l'analyse

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

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

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

ATCC is a registered trademark of American Type Culture Collection

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

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