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material
polyethersulfone
Quality Level
product line
EMPROVE® Filter
parameter
60 psig max. inlet pressure
device size
1.1 in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
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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 Modus Devices are typically used for filtration of pilot to mid-scale batch volumes of proteins. The Viresolve® Pro Modus 1.1 Shield offers a filtration area of 0.017 m2 and has a primary use in small-scale studies/pilot processing.
Viresolve Pro Modus Devices are typically used for filtration of pilot to mid-scale batch volumes of proteins. The Viresolve® Pro Modus 1.1 Shield offers a filtration area of 0.017 m2 and has a primary use in small-scale studies/pilot processing.
Features and Benefits
- Pilot and mid scale manufacturing
- Three different size formats
- Fully self contained (hardware holder not required)
- Fully disposable single-use fluid path
- Devices 100% tested with air/water diffusion and Binary Gas Test
- Shield / Shield H 100% aerosol tested
Other Notes
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).
Analysis Note
TOC/Conductivity
After a controlled water flush of 100 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 100 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
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.
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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