Viresolve Standard Modules

Viresolve Standard Modules

Description
Viresolve standard modules are self-contained, single-use disposable modules designed to remove viruses from protein solutions. 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.

Viresolve modules achieve efficient virus removal while maximizing protein recoveries and minimizing hold-up volumes. The modules are used in a tangential flow filtration mode with two peristaltic pumps for superior transmembrane pressure control.

Each module is supplied with a medical-grade silicone tubing set and gaskets for easy connection to a variety of peristaltic pumps. The modules can be supplied in a number of configurations to meet a variety of process needs. For example, modules are available with accessories suitable for pressure monitoring or diafiltration processes.

Viresolve modules are available with membranes 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 Applications
Viresolve 70 for virus removal from proteins of 70 kD or less:
- Cytokine and lymphokine products
- Small recombinant or transgenic proteins
- Mammalian-extracted hormonal products
- Plasma fractionation products

Viresolve 180 for virus removal from proteins of 180 kD or less:
- Monoclonal antibodies including murine, human and hybrids
- Larger recombinant or transgenic proteins
- Larger plasma fractionation products


Typical Membrane Viral Retention (in Buffer)*

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

Dimensions

Module Length, cm (inch) Width, cm (inch) Height, cm (inch) Weight, kg (lb) 150 cm2 (1/6 ft2) 17.5 (6.9) 9.3 (3.7) 0.9 (0.35) 0.107 (0.236) 0.1 m2 (1 ft2) 17.5 (6.9) 9.3 (3.7) 2.5 (0.98) 0.405 (0.893)

Specifications    (return to top)

Viresolve 1-Stack 150 cm2 (0.16 ft2) Viresolve 6-Stack 0.1 m2 (1 ft2) Materials of Construction Membrane Hydrophilic PVDF Hydrophilic PVDF Module PVDF PVDF Operating Temperature Range 4–37 4–37 pH Range 4–8 4–8 Effective Filtration Area, m2 (ft2) cm2 (ft2) for 1-Stack 150 0.1 Volumes, mL Minimum Working 150 1000 Internal Hold-up 12 70 Pressures, bar (psig) Typical Operating 0.35 (5) @ 4–37 °C 0.35 (5) @ 4–37 °C Transmembrane 0.35 (5) @ 4–37 °C 0.35 (5) @ 4–37 °C Typical Permeate Water Flow Rates, mL/min 2–10 2–60 Bacterial Endotoxins <0.5 EU/mL bacterial endotoxin as determined by the LAL test Gravimetric Extractables ≤3 mg after 24-h soak in water ≤5 mg after 24-h soak in water Oxidizable Substances Meet the current requirements of USP WFI oxidizable substances after a 100 mL water flush Toxicity Component materials meet the current requirements of the USP Class VI Biological Test for Plastics Sterilization Water wet filter, use liquid cycle slow exhaust. Autoclavable @ 121 °C for 60 min 1 time; not steam sterilizable Integrity Testing Viresolve 70 ≥ 1.3 @ 1310 mbar (19 psig) Viresolve 180 ≥ 1.1 @ 1030 mbar (15 psig)

Connections
Medical-grade silicone gasket seal and platinum-cured silicone tube set with fractional sanitary connections

Tubing Set
A sterile, medical-grade silicone tube set is provided with each Viresolve standard module. Each tube set consists of three segments: a feed, retentate, and permeate line. Each tube set has provisions for diafiltration.

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