MFHL06ST3
Millipak® Final Fill 60 Durapore®
Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb
Synonym(s):
Durapore® 0.45 µm, Millipak® Final Fill Capsule
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| Pack Size | SKU | Availability | Price |
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About This Item
Product Name
Millipak® Final Fill 60 Durapore®, Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb
Quality Level
material
PVDF membrane, polysulfone device, polysulfone housing, polysulfone support, silicone O-ring
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
sterile
product line
Millipak® Final Fill
feature
hydrophilic
manufacturer/tradename
Durapore®
parameter
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
technique(s)
bioburden reduction: suitable
filter diam.
7.6 cm (3.0 in.)
filtration area
300 cm2
impurities
<0.25 EU/mL USP 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 at 23 °C
fitting
38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange
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
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This Item | |||
|---|---|---|---|
| pore size 0.45 μm pore size | pore size 0.45 μm pore size | pore size 0.45 μm pore size | pore size 0.45 μm pore size |
| product line Millipak® Final Fill 60 | product line Millipak® Final Fill 60 | product line Millipak® Final Fill 60 | product line Millipak® Final Fill 60 |
| technique(s) bioburden reduction: suitable | technique(s) bioburden reduction: suitable | technique(s) bioburden reduction: suitable | technique(s) bioburden reduction: suitable |
| manufacturer/tradename Millipak® | manufacturer/tradename Millipak® | manufacturer/tradename Millipak® | manufacturer/tradename Millipak® |
| matrix Durapore® | matrix Durapore® | matrix Durapore® | matrix Durapore® |
| material polysulfone device, polysulfone support | material polysulfone device, polysulfone support | material polysulfone device, polysulfone support | material polysulfone device, polysulfone support |
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| MFHL06ST3 | 04054839379949 |