VPMD101NB1

Viresolve^® Pro Device

Parvovirus removal filter, Modus 1.1 format, filtration area 0.017 m²

• Szinonimák: Viresolve^® Pro Device Modus 1.1
• UNSPSC kód: 23151806
• eCl@ss: 32031690

Tulajdonságok

• material: PVDF housing; polyethersulfone membrane; silicone gasket
• Minőségi szint: 400
• termékcsalád: EMPROVE^® Filter
• gyártó/kereskedő neve: Viresolve^®
• parameter: 60 psig max. inlet pressure
• dilution: (Scale studies/Pilot)
• H: 5.92 cm (2.33 in.)
• Hosszúság: 18.62 cm (7.33 in.)
• Szélesség: 9.22 cm (3.63 in.)
• device size: 1.1 in.
• szűrőfelület: 0.017 m²
• szennyeződések: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• szerelvény: 1/4 in. integrated vent hose barb (with double O-ring seal); 3/4 in. sanitary TC inlet/outlet fitting(s)

Leírás

Általános leírás

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 Device Modus 1.1 offers a filtration area of 0.017 m2 and has a primary use in pilot/small-volume processing.

Egyéb megjegyzések

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

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.

Elkészítési megjegyzés

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).

Analízis megjegyzés

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>.

Jogi információk

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

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

Jogi nyilatkozat

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.