灌装间送回风位置对B级区静态悬浮粒子数的影响

Impact from the positioning of the air supply and air return in the product solution filling room on the static air particles of Grade B areas

根据新版GMP附录一‘无菌药品’关于静态B级区悬浮粒子最高允许浓度的规定,结合我厂水针生产线在设计改造和验证过程中碰到的情况,通过对现场实测数据的分析,讨论了灌封间送回风位置对B级区悬浮粒子浓度的影响,对于如何确保达到GMP法规的要求有了比较清晰的认知。

According to the Annex I, ＂Sterile product＂, of the new code of GMP, regarding the maximum allowed concentration of air particles in static Grade B areas, and by integrating the situations occurred during the design, renovation and validation of our injection production line, through analysis of on-site acquired data, the impact from the air supply and air return positions on the concentration of the air particles in Grade B area is discussed in this essay, therefore, how to meet the requirements in the code of GMP is clearly identified.