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MPGL06CL1

Millipore

Durapore® 0.22 µm, Millipak® Capsule

sterile, filtration area 300 cm2, matrix Durapore®

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Synonym(s):
Millipak-60 Filling Machine Filter Unit 0.22 μm 1-1/2 in. TC-1/4 in.HB
eCl@ss:
32031690
NACRES:
NB.24

material

PVDF membrane
PVDF vent cap
polycarbonate
polycarbonate support

Quality Level

sterility

irradiated
sterile

product line

Millipak®

feature

hydrophilic

manufacturer/tradename

Millipak®

parameter

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward)
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
5.2 bar max. inlet pressure (75 psi) at 25 °C
7.6 L/min flow rate at 2.9 bar (ΔP)

technique(s)

sterile filtration: suitable

filtration area

300 cm2

inlet connection diam.

1-1/2 in.

outlet connection diam.

1/4 in.

impurities

≤0.5 EU/mL (LAL test, Aqueous extraction)
<0.5  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤2 mg/device

matrix

Durapore®

pore size

0.22 μm

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

fitting

inlet sanitary flange
outlet hose barb
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

shipped in

ambient

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This Item
MPSL06CL1MPGL06GF2MPGL06GH2
feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

matrix

Durapore®

matrix

Durapore®

matrix

Durapore®

matrix

Durapore®

pore size

0.22 μm

pore size

5.0 μm pore size

pore size

0.22 μm

pore size

0.22 μm

sterility

irradiated, sterile

sterility

irradiated, sterile

sterility

irradiated, sterile

sterility

irradiated, sterile

technique(s)

sterile filtration: suitable

technique(s)

prefiltration: suitable

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

General description

Device Configuration: Capsule
Number of stacked discs: 60 discs

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
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

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: 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

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

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