无菌药品生产净化空调系统的值班模式
Study on duty mode of clean air conditioning system for sterile pharmaceutical production
摘要：
根据《药品生产质量管理规范》（2010年版）对无菌药品生产净化空调系统连续运行的要求，探讨了净化空调系统连续运行在非生产时段洁净区的环境参数控制要求。提出在非生产时段调整环境参数控制要求，按照值班模式运行。对于值班模式的实现提出了相应的技术措施，并结合实际工程案例，分析了值班模式的具体技术措施。
Abstract：
According to the 2010 edition of Good manufacturing practice for pharmaceutical products, air conditioning system for sterile pharmaceutical production should be kept running continuously. Based on this requirement, discusses the requirements of environmental parameters while there are no production activities during the continuous running of air conditioning system. Recommends that control requirements of environmental parameters to be adjusted to duty mode while there are no production activities. Presents different technical measures for duty mode. Combined with an actual case, analyses the specific technical measures for duty mode.
Keywords:sterile drug production environment, clean air conditioning system, duty mode, energy conservation, operation