9Z2786

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

• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF ; polysulfone ; polysulfone support
• Quality Level: 400
• sterility: (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
• feature: hydrophilic
• parameter: 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
• filtration area: 500 cm²
• inlet connection diam.: 1 1/2 in.
• outlet connection diam.: 1-1/2 in.
• size: 100 L
• impurities: <0.25 EU/mL Aqueous extraction (LAL test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.)
• matrix: Durapore^®
• pore size: 0.45 μm
• bubble point: ≥26 psi (1790 mbar), air with water
• fitting: inlet sanitary flange; outlet sanitary flange; 38 mm (1 1/2 in.) sanitary flange drain/vent
• suitability: 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

General description

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

Packaging

Double Easy-Open bag

Legal Information

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

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

Disclaimer

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