MSP010013

Millipak^® Barrier Capsule Media: Durapore^® 0.22 µm

Chemistry: Hydrophobic/Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange

• Synonym(s): Durapore Millipak Barrier 200, 0.22 μm, Hydrophobic/Hydrophilic, TC/TC, Hydrophilic/Hydrophobic Durapore^® 0.22 µm, Millipak^® Barrier 200 Capsule
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Properties

• Product Name: Millipak^® Barrier Capsule Media: Durapore^® 0.22 µm, Chemistry: Hydrophobic/Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange
• material: PVDF
• Quality Level: 400
• description: hydrophobic/hydrophilic
• sterility: irradiated, non-sterile
• sterilization compatibility: gamma compatible
• product line: Millipak^® Barrier 200
• feature: hydrophilic, hydrophobic
• manufacturer/tradename: Durapore^®
• technique(s): sterile filtration: suitable
• L: 6.1 in.
• W: 3.0 in.
• filtration area: 1000 cm²
• inlet connection diam.: 1.5 in.
• outlet connection diam.: 1.5 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Durapore^®
• pore size: 0.22 μm
• fitting: inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

Preparation Note

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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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.

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

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

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

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