Virus removal filters feature nanoscale pores, and these small pores are highly susceptible to clogging or fouling by components in the product stream. Therefore, the virus filtering process often has problems such as low filtration capacity, increased cost, and prolonged processing time. Without changing the state of the sample, adding a pre-filter is the most effective solution to increase the capacity. The pre-filter is designed to be placed upstream of the virus filter to capture these fouling substances such as protein aggregates, host cell proteins, and DNA.
The pre-filter commonly works through adsorption, where impurities are adhered to the pre-filtering media, or through filtration based on larger pore sizes to remove larger particles. By using a pre-filter to prevent the final filter from getting clogged, the processing capacity or throughput of the virus filtration process can be significantly improved. This enables the use of smaller and more economical virus filters, and ensures more consistent and predictable performance between batches.
Amerigo Scientific provides Vshell® pre-filters that are specially designed to work together with Valpha® virus retention filters to provide a reliable virus safety guarantee for the virus filtration process. A variety of specifications of Vshell® pre-filters are available to meet different process requirements, thereby achieving effective and robust virus removal results.
| Product | Filtration Area | Application |
|---|---|---|
| Vshell® Syringe Pre-Filter | 5cm² | R&D |
| Vshell® Capsule Pre-Filter | 100cm²; 250cm²; 500cm²; 1000cm² | R&D or Pilot scale |
| Vshell® Plate Pre-Filter | 0.5m²; 1m² | Process scale |
| Specification | 5cm² | 100cm² | 250cm² | 500cm² | 1000cm² | 0.5m² | 1m² | |
| Type | Syringe filter | Capsule filter | Plate filter | |||||
| Size | Diameter (mm) | 36 | 94 | 94 | 94 | 94 | 442 | 442 |
| Height (mm) | 16.2 | 143 | 203 | 331 | 578 | 106 | 147 | |
| Connection | Luer | TC25 | TC50 | |||||
| Application | R&D | R&D | Pilot scale | Pilot scale | Pilot scale | Process scale | Process scale | |
| Capacity | 0-1L | 1-20L | 1-20L | 1-100L | 1-100L | 100-500L | 100-2000L | |
| Material | Membrane | Diatomite, cellulose, perlite, positive charge resin | ||||||
| Housing | Polypropylene | |||||||
| Pressure test | 25°C water bath, maintaining 50 psi for 24 hours, with no gas leakage from the filter; 40°C water bath, maintaining 40 psi for 24 hours, with no gas leakage from the filter |
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| Hydraulic stress test | 40psi, 30min, 4cycles | |||||||
| TOC | After flushing 100 L/m², TOC was < 4mg/L | |||||||
| Conductivity | After flushing 100 L/m², conductivity was 10 μS/cm | |||||||
| Bacterial endotoxins | After flushing 100 L/m², endotoxin was <0.25 EU/ml | |||||||
| Biosafety test | The used materials meet the standards of USP <87> and USP <88> biosafety test | |||||||
(Protein Conc.: 6.7g/L; Mass Capacity: 7-8kg/m2)
| Number | Experimental Volume Capacity | Average Flux | Flow Rate Attenuation | LRV |
| (L/m²) | (LMH) | (%) | ||
| MVM Run1 | 1177.46 | 469.42 | 47.39 | >6 |
| MVM Run2 | 1171.04 | 532.29 | 41.96 | >6 |
| X-MuLV Run1 | 1181.79 | 447.34 | 47.78 | >4 |
| X-MuLV Run2 | 1172.43 | 450.93 | 48.51 | >4 |
| Reo-3 Run1 | 1173.75 | 467.01 | 44.93 | >4 |
| Reo-3 Run2 | 1171.68 | 446.35 | 48.3 | >4 |
| PRV Run1 | 1171.75 | 435.33 | 54.07 | >4 |
| PRV Run2 | 1167.11 | 402.45 | 55.21 | >4 |
Valpha® virus removal filters are designed for efficiently removing virus particles from biological products such as plasma products, antibodies, and proteins. Based on innovative high-performance polymer membranes (Regenerated Cellulose (RC) or Modified Polyethersulfone (PES)), these filters trap viruses on the membrane surface and in the membrane pores.
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