material
PVDF (modified), polypropylene , silicone seal
manufacturer/tradename
Viresolve®
parameter
≤20 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water), 3.4 bar max. differential pressure (50 psid) (Reverse), 5.5 bar max. differential pressure (80 psid) (Forward), 500 L process volume
technique(s)
protein purification: suitable
cartridge nominal length
20 in. (50 cm)
filtration area
0.84 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Viresolve® NFP
cartridge code
Code 7
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General description
Device Configuration: Cartridge
Application
Parvovirus removal
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
This product was manufactured with a Viresolve® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Other Notes
Directions for Use
- Organism Retention: Parvovirus
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Viral clearance
- Instructions for Use: Please see the user guide shipped with this product
- Storage Statement: Store at room temperature
- 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
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
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