Documents

MCHL40S03

Millipore

Millidisk® Cartridge

sterile, filtration area 2000 cm2, hydrophilic

Synonym(s):
Millidisk Cartridge 40-stack 0.45 μm Hydrophilic
eCl@ss:
32031690

Quality Level

material

PVDF
polysulfone
polysulfone support
silicone seal

sterility

sterile

feature

hydrophilic

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)
75 L/min flow rate at 2.7 bar (ΔP)

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)

gravimetric extractables

≤10 mg/device

matrix

Durapore®

pore size

0.45 μm nominal pore size
0.45 μm pore size

input

sample type liquid

bubble point

≥1790 mbar (26 psig), air with water at 23 °C

cartridge code

not applicable

General description

Stack Design: 40 Stak
Device Configuration: Cartridge

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

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).
Sterilization Method
5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C

Analysis Note

Gravimetric Extractables: using sterilized device after 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
MILLIDISK is a registered trademark of Merck KGaA, Darmstadt, Germany

Certificate of Analysis

Certificate of Origin

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