VPPS202NB1

Viresolve^® Pro Modus 2.2

• Synonim(y): Viresolve^® Pro Magnus 2.2 Shield
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: polyethersulfone
• Poziom jakości: 400
• linia produktu: EMPROVE^® Filter
• Parametry: 60 psig max. inlet pressure
• dilution: (Large volume processing)
• device size: 2.2 in.
• zanieczyszczenia: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

Opis

Opis ogólny

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 Magnus 2.2 Shield offers a filtration area of 1.53 m² and has a primary use in large-volume processing.

Cechy i korzyści

• 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

Inne uwagi

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

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>.

Informacje prawne

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany

Oświadczenie o zrzeczeniu się odpowiedzialności

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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