MPHL02GF2

Durapore^® 0.45 µm, Millipak^® Capsule

• Synonym(s): Sterile Millipak-20 Filter Unit 0.45 μm 3/4 in. TC/TC
• UNSPSC Code: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Properties

• manufacturer/tradename: Millipak^®
• Quality Level: 400
• 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)

Description

General description

Device Configuration: Gamma Gold Capsule

Number of stacked discs: 20 discs

Packaging

Blister

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

Preparation Note

Sterilization Method
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable

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).

Analysis Note

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

Legal Information

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

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