Viresolve Process Area Modules

Viresolve Process Area Modules

Description
Viresolve process area modules are self-contained, single-use disposable modules designed to remove viruses from protein solutions at process scale. Viresolve modules are fabricated from a single material of construction, polyvinylidene fluoride (PVDF). The modules are thermally bonded and no solvents are used in fabricating the units. The modules are used in a tangential flow filtration mode with two peristaltic pumps or other pharmaceutical-grade pumps for superior transmembrane pressure control.

Viresolve modules achieve efficient virus removal while maximizing protein recoveries and minimizing hold-up volumes. They are available for use with both small proteins (typically ≤ 70 kD) and larger protein products (typically ≤ 180 kD). Both offer excellent virus retentive capabilities, and are consistently capable of protein recoveries exceeding 90%.

Each unit is 100% integrity tested during manufacturing by CorrTest to assure integrity.


Typical Membrane Viral Retention

Viresolve 70 Viresolve 180 Polio Virus 3.5 logs 2 logs Hepatitis A * 4 logs SV-40 5.6 logs * Sindbis 7.4 logs 4.5 logs Reovirus 3 7.2 logs 5.5 logs Murine Leukemia Virus (MuLV) 6.6 logs 6.0 logs Human Immunodeficiency Virus (HIV) 8.5 logs * Typical Membrane Viral Retention in Buffer; Retention in Protein is higher *Testing not done

Dimensions

Module Length, cm (inch) Width, cm (inch) Height, cm (inch) Weight, kg (lb) 10-stacks 38.6 (15.2) 19.4 (7.6) 6.7 (2.63) 4.1 (9.0) 20-stacks 38.6 (15.2) 19.4 (7.6) 9.85 (3.88) 6.4 (14.1)

Specifications    (return to top)

10-stack Modules 20-stack Modules Materials of Construction Membrane Hydrophilic PVDF Hydrophilic PVDF Module PVDF PVDF Operating Temperature Range, °C 4–37 4–37 pH Range 4–8 4–8 Effective Filtration Area, m2 (ft2) 0.7 1.4 Volumes, mL Minimum Working system dependent system dependent Internal Hold-up 825 1410 Pressures, bar (psig) Typical Operating 0.35 (5) @ 4–37 °C 0.35 (5) @ 4–37 °C Maximum Transmembrane 0.35 (5) @ 4–37 °C 0.35 (5) @ 4–37 °C Typical Permeate Water Flow Rates, mL/min 100–720 200–1500 Bacterial Endotoxins < 0.5 EU/mL bacterial endotoxin as determined by the LAL test Gravimetric Extractables ≤100 mg after 24-h soak in water ≤200 mg after 24-h soak in water Oxidizable Substances Meet the current requirements of USP WFI oxidizable substances after a 1 L water flush per 10 stack Toxicity Component materials meet the current requirements of the USP Class VI Biological Test for Plastics Sterilization Not autoclavable or steam-sterilizable Integrity Testing - CorrTest Viresolve 70 ≥ 1.3 @ 1310 mbar (19 psig) Viresolve 180 ≥ 1.1 @ 1030 mbar (15 psig)

Pump Specifications
Two peristaltic or rotary lobe pumps required (not included)
For more information on Viresolve system accessories, please call Millipore