产品名称
Viresolve 屏障微型工艺开发试剂盒, Process Development Kit
material
molded polypropylene component(s)
polyethersulfone membrane
teal device
manufacturer/tradename
Viresolve®
parameter
4.1 bar max. inlet pressure (60 psig)
dilution
(process development studies)
H × diam.
3.83 cm (1.51 in.) × 3.07 cm (1.21 in.)
H
3.83 cm (1.51 in.)
diam.
3.07 cm (1.21 in.)
filtration area
3.3 cm2
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
fitting
female Luer inlet fitting
male Luer outlet fitting
Analysis Note
TOC/Conductivity
After a controlled water flush of 40 L/m2, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
After a controlled water flush of 40 L/m2, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
Application
Process Development Kit
General description
Device Configuration: Micro
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.
Preparation Note
This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Legal Information
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
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