MPGL02GF2
Durapore® 0.22 µm, Millipak® Capsule
Synonym(s):
Sterile Millipak-20 Filter Unit 0.22 μm 3/4 in. TC/TC
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About This Item
UNSPSC Code:
23151806
eCl@ss:
32031690
NACRES:
NB.24
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manufacturer/tradename
Millipak®
Quality Level
matrix
Durapore®
pore size
0.22 μm
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
inlet sanitary flange
outlet sanitary flange
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
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General description
Device Configuration: Gamma Gold Capsule
Packaging
Blister
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
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.
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 a 200 mL flush and 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
Emprove 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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