目的  对疫苗生产车间半成品配制区域的悬浮粒子进行动态监测和数据分析。方法  采用便携式悬浮粒子采样仪，于2016和2017年对乙型脑炎减毒活疫苗生产洁净车间进行日常悬浮粒子检测，其中A、B级洁净区域为班次检测，C级洁净区域为每周检测。对2年的检测数据制作单值-移动极差控制图，并进行t检验比较。结果  3个级别洁净区域的悬浮粒子数或均值如下，A级区≥0.5 μm的粒子数均<1，≥5.0 μm的粒子数均为0。B级区≥0.5 μm的粒子数均值：2016年为46.82（0～143.21），2017年为38.83（0～125.33）；≥5.0 μm的粒子数均值：2016年为2.52（0～7.83），2017年为2.41（0～7.15）。C级区≥0.5 μm的粒子数均值：2016年为214.64（0～679.16），2017年为209.81（0～619.31）；≥5.0 μm的粒子数均值：2016年为15.04（0～47.13），2017年为14.16（0～39.24）。3个洁净区域的悬浮粒子数均小于95%置信上限且均符合GMP范围要求。2016和2017年检测数据的差异无统计学意义（t值为0.14～1.02，P值均>0.05）。结论  疫苗生产车间半成品配制区的悬浮粒子动态监测结果符合GMP标准。

Objective  To analyze dynamic monitoring data of suspended particles in the semi-finished product preparation area of a vaccine production workshop. Methods  The portable suspended particle sampler was used to conduct daily detection in clean workshop for live attenuated Japanese encephalitis vaccine production from 2016 to 2017. The A- and B-class clean areas were detected every shift, and the C-class clean area was detected weekly. The 2 year data were used to make individual-moving range charts and compared by t-test.  Results The number or mean value of suspended particles in the 3 class clean areas was as follows. The number of particles ≥0.5 μm in A-class area was <1 and the number of particles ≥5.0 μm was 0. The mean values of particles ≥0.5 μm in B-class area were 46.82 (0-143.21) in 2016 and 38.83 (0-125.33) in 2017; the mean values of particles ≥5.0 μm were 2.52 (0-7.83) in 2016 and 2.41 (0-7.15) in 2017. The mean values of particles ≥0.5 μm in C-class area were 214.64 (0-679.16) in 2016 and 209.81 (0-619.31) in 2017; the mean values of particles ≥5.0 μm were 15.04 (0-47.13) in 2016 and 14.16 (0-39.24) in 2017. The number of suspended particles in the 3 clean areas was less than the 95% upper confidence limit and met the GMP range requirement. The difference between the data from 2016 to 2017 was not statistically significant (t=0.14-1.02, all P>0.05). Conclusion The dynamic monitoring of suspended particles in the semi-finished product preparation area of the vaccine workshop meets the GMP requirements.