MPHL06GF2

Durapore^® 0.45 µm, Millipak^® Capsule

Millipak^® 60, sterile

• Synonym(s): Sterile Millipak-60 Filter Unit 0.45 μm 3/4 in. TC/TC
• UNSPSC Code: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Properties

• material: PVDF membrane; PVDF vent cap; polycarbonate ; polycarbonate support
• Quality Level: 400
• sterility: irradiated; sterile
• product line: Millipak^® 60
• feature: hydrophilic
• manufacturer/tradename: Millipak^®
• parameter: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 10.5 L/min flow rate at 2.45 bar (ΔP); 30 L process volume; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C
• technique(s): bioburden reduction: suitable
• filtration area: 300 cm²
• inlet connection diam.: 3/4 in.
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤2 mg/device
• matrix: Durapore^®
• pore size: 0.45 μm
• bubble point: ≥1790 mbar (26 psig), air with water at 23 °C
• fitting: inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
• shipped in: ambient

Description

General description

Device Configuration: Gamma Gold Capsule

Analysis Note

Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature

Other Notes

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 for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Legal Information

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

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