疫苗生产洁净车间悬浮粒子的动态监测和趋势分析  

Dynamic monitoring and trend analysis of suspended particles in clean workshop for vaccine production

作　　者：陈佩[1] 李毅[1] 户美玲[1] 彭兴梅[2] 刘竞鸥 唐溯[1] 任文洲 罗辉艳 皮儒亮 刘菊[1] Chen Pei;Li Yi;Hu Meiling;Peng Xingmei;Liu Jing’ou;Tang Su;Ren Wenzhou;Luo Huiyan;Pi Ruliang;Liu Ju(Quality Control Department,Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China;Bacterial Vaccine Room 1,Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China)

机构地区：[1]成都生物制品研究所有限责任公司质量检定室,610023 [2]成都生物制品研究所有限责任公司细菌性疫苗一室,610023

出　　处：《国际生物制品学杂志》2019年第1期6-10,共5页International Journal of Biologicals

摘　　要：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级洁净区域为每班次检测,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,≥5.0μm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);≥5.0μm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 semifinished 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 individualmoving range charts and compared by t-test.Results The number or mean value of suspended particles in 3 classes 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 ≥0.5μm 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 ≥5.0μm were 15.04 (0-47.13) in 2016 and 14.16 (0-39.24) in 2017.The number of suspended particles in 3 clean areas was less than the 95 % upper confidence limit and met the GMP range requirement.The difference between 2016 and 2017 data was not statistically significant (t=0.14-1.02,all P >0.05).Conclusion The dynamic monitoring result of suspended particles in the semi-finished product preparation area of the vaccine workshop meets the GMP requirements.

关 键 词：环境 受控 空气污染物 环境监测 日本脑炎疫苗 

分 类 号：TQ460.8[化学工程—制药化工]