MCGBL4S03

Hydrophilic/Hydrophobic Durapore^® 0.22 µm, Millidisk^® Barrier 40 Cartridge

Millidisk^® Barrier 40

• Synonym(s): Millidisk^® Barrier Filter 0.22 µm hydrophilic/phobic
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF ; polysulfone ; polysulfone support; silicone seal
• Quality Level: 400
• description: hydrophobic/hydrophilic
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: Millidisk^® Barrier 40
• feature: hydrophilic; hydrophobic
• manufacturer/tradename: Millidisk^®
• parameter: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward); 7.6 L/min flow rate at 1 bar (ΔP)
• technique(s): gas filtration: suitable
• filtration area: 2000 cm²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Durapore^®
• pore size: 0.22 μm
• input: sample type liquid
• bubble point: ≥1280 mbar (18.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• cartridge code: not applicable

Description

General description

Device Configuration: Cartridge

Stack Design: 40 Stak

Packaging

Double Easy-Open bag

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
4 SIP cycles of 60 min @ 135 °C; 4 autoclave cycles of 60 min @ 126 °C

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.

Legal Information

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

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

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