VHP灭菌技术在无菌检查试验中的应用

Study on VHP Sterilization Technology in Sterility Test

为研究汽化过氧化氢灭菌技术(VHP)在无菌检查过程中的应用,将供试品等物品放入VHP传递仓灭菌,使用既定灭菌参数,通过BI挑战性试验、灵敏度试验等验证灭菌后的参数是否符合质量标准的要求。结果表明,使用既定参数设定,可以将VHP灭菌技术运用于疫苗无菌检查物品表面灭菌中,方法可靠有效。

To study the application of vaporized hydrogen peroxide sterilization technology(hereinafter referred to as VHP)in the sterile examination process.The tested products and other articles were put into the VHP transfer warehouse for sterilization,and the established sterilization parameters were used to verify whether the parameters after sterilization met the requirements of the quality standard through BI challenging test and sensitivity test.The VHP sterilization technology can be used to sterilize the surface of sterile inspection articles of vaccine by using the set parameters,and the method is reliable and effective.