9Z2786

Non-sterilized Millipak^® Final Fill 100 Filter Unit 0.45  µm 1 1/2  in. TC/TC

• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PVDF ; polysulfone ; polysulfone support
• Niveau de qualité: 400
• Stérilité: (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.); non-sterile
• Caractéristiques: hydrophilic
• Paramètres: 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 3.0 L/min flow rate at 0.69 bar; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward); 80 psi max. inlet pressure (5.5 bar) at 25 °C
• Surface de filtration: 500 cm²
• Diam. du raccord d'entrée: 1 1/2 in.
• Diam. du raccord de sortie: 1-1/2 in.
• Taille: 100 L
• Impuretés: <0.25 EU/mL Aqueous extraction (LAL test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.)
• Matrice: Durapore^®
• Dimension de pores: 0.45 μm
• Point de bulle: ≥26 psi (1790 mbar), air with water
• Raccords: inlet sanitary flange; outlet sanitary flange; 38 mm (1 1/2 in.) sanitary flange drain/vent
• Adéquation: suitable for endotoxin (Aqueous extraction contains < 0.25<nbsp/> EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.)

Description

Description générale

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

Conditionnement

Double Easy-Open bag

Informations légales

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

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

Clause de non-responsabilité

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