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Merck
CN

MPGL10CL3

Millipak® 100 Capsule Media: Durapore® 0.22 µm

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

Synonym(s):

Gamma Compatible Millipak -100 Filter Unit 0.22 μm 1-1/2 in. TC/TC, Millipak® 100 Capsule Media: Durapore® 0.22 µm

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About This Item

UNSPSC Code:
23151806

Key Documents

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Product Name

Durapore® 0.22 µm, Millipak® Capsule, filtration area 500 cm2, matrix Durapore®

material

PVDF vent cap, polycarbonate support, PVDF membrane, polycarbonate housing

sterility

non-sterile

product line

Millipak®

Quality Level

400

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterilization compatibility

gamma compatible
x-ray compatible

feature

hydrophilic

manufacturer/tradename

Durapore®

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)

technique(s)

sterile filtration: suitable

W

3.0 in.

filter diam.

7.6 cm (3.0 in.)

filtration area

500 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)

gravimetric extractables

≤2.5 mg/device

matrix

Durapore®

pore size

0.22 μm

bubble point

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

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

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General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

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

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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