疫苗分装区环境监测与质量控制分析  

Environmental monitoring and quality control analysis of vaccine filling area

作　　者：江莉 王石全[2] 陈佩[2] 罗珊[2] 户美玲[2] 刘菊[2] 彭爱华[1] Jiang Li;Wang Shiquan;Chen Pei;Luo Shan;Hu Meiling;Liu Ju;Peng Aihua(State Key Laboratory of Biotherapy, Sichuan University, Chengdu 610041, China;Department of Quality Control, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China)

机构地区：[1]四川大学生物治疗国家重点实验室,成都610041 [2]成都生物制品研究所有限责任公司质量检定室,610023

出　　处：《国际生物制品学杂志》2019年第3期120-124,共5页International Journal of Biologicals

摘　　要：目的建立洁净区环境监测微生物数据库,统计分析悬浮粒子动态监测变化情况,确认疫苗分装区的洁净度符合疫苗生产要求。方法对疫苗分装区进行空气调节系统性能再验证环境监测,对该区域的培养基灌装试验进行在线环境监测,对以上所有环境监测获得菌进行菌型分析,建立环境监测微生物数据库。结果在分装前准备、分装中产品入柜和排除故障、分装后清场期间,悬浮粒子浓度变化明显,出现峰值(≥0.5 μm悬浮粒子浓度最大值1 624粒/m3),但整体水平仍较低。监测到的微生物主要菌型包括里拉/藤黄微球菌、蜡状芽孢杆菌、人葡萄球菌、科氏葡萄球菌科氏亚种、沃氏葡萄球菌等。结论疫苗分装区洁净度符合无菌药品生产要求,环境监测微生物数据库的建立和悬浮粒子监测结果的统计分析,为制定有效的无菌药品生产质量控制措施提供了必要且针对性较强的依据。Objective To construct a clean area environmental monitoring microorganism database, and statistically analyze changes in the dynamic monitoring of airborne particulates, in order to confirm that the cleanliness of vaccine filling area meets vaccine production requirements. Methods The heating, ventilating and air conditioning system performance re-validation environment monitoring was carried out on the vaccine filling area. The online environment monitoring of the medium filling test in the area was performed. All bacteria obtained from environmental monitoring were subjected to bacterial type analysis to establish an environmental monitoring microorganism database. Results The concentration of airborne particulates varied significantly during pre-filling preparation, product entering into cabinet, troubleshooting and post-filling clearing, reaching peak values (maximum concentration of particles ≥0.5 μm at 1 624 /m3), though overall level was still low. The main bacterial types detected included lira/Micrococcus luteus, Bacillus cereus, Staphylococcus hominis, Staphylococcus cohnii subsp. cohnii and Staphylococcus warneri. Conclusions The cleanliness of the vaccine filling area meets the requirements for the production of sterile drugs. The establishment of the environmental monitoring microorganism database and the statistical analysis of the results from suspended particle monitoring help to trace the source of contamination in sterile drugs, and provide the necessary and highly targeted basis to establish effective quality control for sterile pharmaceutical production.

关 键 词：环境监测 颗粒物 微生物数据库 微生物污染 

分 类 号：TQ464[化学工程—制药化工]