MFHL06ST3
Durapore® 0.45 µm, Millipak® Final Fill Capsule
Millipak® Final Fill 60, sterile; γ-irradiated
material
polysulfone device
polysulfone support
Quality Level
Agency
meets EP 2.6.14
meets JP 4.01
meets USP 85
sterility
irradiated
sterile; γ-irradiated
product line
Millipak® Final Fill 60
feature
hydrophilic
manufacturer/tradename
Millipak®
parameter
1.5 L/min flow rate at 0.69 bar (ΔP)
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
5.5 bar max. inlet pressure (80 psi) at 25 °C
60 L process volume
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
technique(s)
bioburden reduction: suitable
filter filtration area
300 cm2
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction)
<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
matrix
Durapore®
pore size
0.45 μm pore size
bubble point
≥26 psi (1790 mbar), air with water
fitting
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
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General description
Packaging
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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections
Other Notes
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer general guidelines section of user guide shipped with this product
- Storage Statement: Please refer user guide shipped with this product
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
Legal Information
Regulatory Information
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