MCGB10S02

Millidisk^® 10 Cartridge Media: Durapore^® 0.22 µm

Chemistry: Hydrophobic Polyvinylidene Fluoride (PVDF)

• Synonym(s): Millidisk Cartridge 10-stack 0.22 m hydrophobic, Hydrophobic Durapore^® 0.22 µm, Millidisk^® Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Properties

• Product Name: Millidisk^® 10 Cartridge Media: Durapore^® 0.22 µm, Chemistry: Hydrophobic Polyvinylidene Fluoride (PVDF)
• Quality Segment: 400
• material: PVDF , polysulfone , polysulfone support, silicone seal
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Millidisk^® 10
• feature: 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)
• technique(s): gas filtration: suitable
• filtration area: 500 cm²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤2.5 mg/device
• matrix: Durapore^®
• pore size: 0.22 μm
• input: sample type liquid
• bubble point: ≥1170 mbar (17.0 psig), nitrogen with 100% IPA at 23 °C
• cartridge code: not applicable

Description

General description

Device Configuration: Cartridge

Stack Design: 10 Stak

Packaging

Easy-Open bag

Preparation Note

Sterilization Method
5 SIP cycles of 30 min @ 135 °C; 5 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.

Gravimetric Extractables: using sterilized device after 24 hours in a 70/30% IPA/water mixture 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.

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

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