Table 2.
Virus reduction factors (log) for relevant viruses reported for individual process stepsa
| Process step evaluated | Virus reduction factors (log) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Enveloped viruses | Non‐enveloped viruses | |||||||||
| HIV, | HCV model, | HBV model | HAV and model | B19V and model | ||||||
| HIV‐1 | BVDV | BHV | PRV | HAV | POL | B19V | PPV | CPV | MMV | |
| Lyophilization17, 45 | 1.2 | 1.7 | 1.3 | – | 2.1 | 3.4 | – | <1.0 | – | |
| Precipitation | ||||||||||
| Cryoprecipitation32 | – | – | – | 1.6 | 1.5 | – | – | 1.5 | – | |
| 3.5% PEG precipitation17 | <1.0 | <1.0 | <1.0 | – | – | 3.3 | – | 1.2 | – | |
| Al(OH)3 adsorption/glycine precipitation/NaCl precipitation32 | 3.6 | 2.4 | – | 3.7 | 2.4 | – | – | 3.4 | – | |
| S/D17, 46 | ≥11.1 | ≥4.5 | ≥8.0 | ≥8.5 | NA | NA | NA | NA | NA | |
| Dry heat17, 45, 46 | 5.2b | ≥4.9c | 2.1c | 4.9d | ≥5.8c | ≥2.5c | 4.1d | 4.1c | – | |
| Pasteurizatione, 32 | ≥6.4 | ≥8.9 | – | 4.6 | 4.2 | – | ≥3.9 | 1.1 | – | |
| Chromatography17 | ≥2.0 | <1.0 | 7.6 | – | – | <1.0 | – | <1.0 | – | |
| Virus filtration19, 47 | >6.4f | 6.6** | – | >6.0f | 6.8** | – | – | – | ≤1.0f | |
| Vapor heat19, 48 | >6.8 | >7.1 | – | >7.4 | >4.5 | – | ≥3.5g | – | ≤1.0 | |
a
Dashes indicate that no data are available.
b
100°C for 30 min.
c
80°C for 72 hr.
d
100°C for 120 min.
e
In aqueous solution at 60°C for 10 hr.
f
35‐nm filtration.
35‐ to15‐nm sequential filtration.
g
60°C for 500 min, followed by 80°C for 60 min.
BHV = bovine herpes virus (a nonspecific model virus for HBV); CPV = canine parvovirus (a model virus for B19V); MMV = mice minute virus (a model virus for B19V); NA = not applicable; PEG = polyethylene glycol; POL = poliovirus Sabin type 2.