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.
关键词
采暖通风与空调调节系统/人用疫苗检查/检查缺陷/生物安全/浙江省
Key words
heating,ventilation,and air conditioning regulation system/human vaccine inspection/inspection defects/biosafety/Zhejiang Province
维普
万方数据