产品名称
Viresolve Pro Magnus 2.2 护罩, MAX PRESSURE 60 PSI (4.1 bar)
material
polyethersulfone
Quality Segment
product line
EMPROVE® Filter
parameter
60 psig max. inlet pressure
dilution
(Large volume processing)
device size
2.2 in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
General description
The Viresolve® Pro Solution provides a comprehensive, flexible template solution for viral clearance within mAb and recombinant protein bioproduction. This proven viral clearance solution delivers the highest levels of retention assurance and productivity across a broad range of feed stream characteristics.
Viresolve Pro Magnus Devices are typically used for filtration of mid to large scale batch volumes of proteins. The Viresolve® Pro Shield Magnus 2.2 offers a filtration area of 1.53 m2 and has a primary use in large-volume processing.
Viresolve Pro Magnus Devices are typically used for filtration of mid to large scale batch volumes of proteins. The Viresolve® Pro Shield Magnus 2.2 offers a filtration area of 1.53 m2 and has a primary use in large-volume processing.
Features and Benefits
- Large scale manufacturing
- Two different size formats
- Integrated gaskets
- Units are stackable in the Viresolve® Pro/Pro+ Magnus Holder (up to 7 units)
- Alignment keys on each unit to minimize errors during installation
- Fully disposable single-use fluid path
- Devices 100% tested with air/water diffusion and Binary Gas Test
- Shield / Shield H 100% aerosol tested
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).
Analysis Note
TOC/Conductivity
After a controlled water flush of 50 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 50 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
Other Notes
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
Disclaimer
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
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