产品名称
Durapore® 0.45 µm, Millipak® Final Fill灌装囊式过滤器, Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb
Quality Level
material
PVDF membrane, 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
non-sterile
sterilization compatibility
gamma compatible
x-ray compatible
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
W
3.0 in.
filter diam.
7.6 cm (3.0 in.)
filter filtration area
300 cm2
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample 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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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| MFHL06GT3 | 04054839379895 |