浙江省人用疫苗生产企业采暖通风与空调调节系统检查缺陷分析

Defects in Heating,Ventilation,and Air Conditioning System Inspection of Human Vaccine Manufacturers in Zhejiang Province

目的为我国疫苗的监管及其行业发展提供参考。方法对浙江省人用疫苗生产企业2017年至2021年各类官方检查中有关采暖通风与空调调节(HVAC)系统的缺陷进行梳理和分析,从缺陷分布、缺陷产生原因等方面剖析疫苗生产企业存在的问题。结果与结论疫苗生产企业需完善质量管理体系文件,加强人员培训;科学评估,加强环境微生物动态监测;科学设计厂房及设施、设备,做好日常维护;落实疫苗生产车间HVAC系统生物安全相关要求,提升全员生物安全意识。

Objective To provide a reference for the regulation and industry development of vaccines in China.Methods The defects related to heating,ventilation,and air conditioning(HVAC)system in various official inspections of human vaccine manufacturers in Zhejiang Province from 2017 to 2021 were sorted out and analyzed,and the problems of vaccine manufacturers in the HVAC system were analyzed from the aspects of defect distribution and causes of defects.Results and Conclusion Vaccine manufacturers should improve their quality management system documents and strengthen personnel training,conduct scientific assessments and strengthen dynamic monitoring of environmental microorganisms,scientifically design plants,facilities and equipment,and carry out daily maintenance,implement biosafety-related requirements for the HVAC system in vaccine production workshops,and enhance the biosafety awareness of all staff.