MFHL06ST3

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

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

• UNSPSC Code: 23151806

Properties

• material: polysulfone device; polysulfone support
• Quality Level: 400
• agency: meets EP 2.6.14; meets JP 4.01; meets USP 85
• sterility: irradiated; sterile; γ-irradiated
• product line: Millipak^® Final Fill 60
• feature: hydrophilic
• manufacturer/tradename: Millipak^®
• parameter: 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
• impurities: <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)
• matrix: Durapore^®
• pore size: 0.45 μm pore size
• bubble point: ≥26 psi (1790 mbar), air with water
• fitting: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Gamma Gold Capsule

Packaging

Double Easy-Open bag

Preparation Note

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

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 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.

Legal Information

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

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