Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Étoile, France.
Biologicals. 2020 Sep;67:75-80. doi: 10.1016/j.biologicals.2020.07.007. Epub 2020 Aug 15.
Effective decontamination procedures are critical to the successful manufacture and control of poliovirus vaccines to minimize the risk to personnel and the environment. Polio viruses have been reported to be more resistant to disinfectants than many other viruses. We assessed the efficacy of sodium hypochlorite-containing disinfectants for decontamination for three poliovirus serotypes to implement decontamination procedures that are fully compliant with the WHO GAP III and Health authorities' requirements. A 10.4 log reduction was observed with a 0.63% sodium hypochlorite solution in a suspension with high protein and high poliovirus concentrations diluted 10-fold compared with a 6 log reduction in an undiluted sample. Treatment efficacy increased with sodium hypochlorite content and decreased with sample protein content. The surface tests showed that two 1-min treatments, 5-min apart, with a 0.63% Chl sodium hypochlorite solution effectively reduced the concentration of all poliovirus serotypes by 10 log, irrespective of the protein and virus concentration in the sample. Sodium hypochlorite solutions lower than 0.52% were less effective for complete inactivation of poliovirus. In conclusion, we demonstrated that a high level of virus reduction (>10 log) can be achieved with sodium hypochlorite solutions with poliovirus in suspension and dried on surfaces.
有效的消毒程序对于成功制造和控制脊髓灰质炎病毒疫苗至关重要，以最大程度地降低人员和环境的风险。据报道，脊髓灰质炎病毒比许多其他病毒更能抵抗消毒剂。我们评估了含次氯酸钠的消毒剂对三种脊髓灰质炎病毒血清型的消毒效果，以实施完全符合世界卫生组织 GAP III 和卫生当局要求的消毒程序。与未经稀释的样品相比，在高浓度蛋白质和高浓度脊髓灰质炎病毒的悬浮液中，0.63%的次氯酸钠溶液可实现 10.4 个对数减少，而稀释 10 倍的样品则可实现 6 个对数减少。处理效果随次氯酸钠含量的增加而增加，随样品蛋白质含量的增加而降低。表面测试表明，用 0.63%的次氯酸钠溶液进行两次 1 分钟、间隔 5 分钟的处理，可有效将所有脊髓灰质炎病毒血清型的浓度降低 10 个对数，而与样品中的蛋白质和病毒浓度无关。次氯酸钠溶液浓度低于 0.52%时，对于完全灭活脊髓灰质炎病毒的效果较差。总之，我们证明了在悬浮液和干燥表面的脊髓灰质炎病毒中，高浓度的病毒减少（>10 个对数）可以通过次氯酸钠溶液实现。
