摘要
根据湿热灭菌原理,针对制药行业目前所用湿热灭菌设备,参考2010版GMP,明确设备DQ/IQ/OQ/PQ确认要点,对确认工作的细节问题提出看法和建议。确认的目的是使设备选型合理、运行稳定、性能可靠,灭菌物品得到充分无菌保证。
Define key points of the Design/Installation/Operation/Performance qualifications of autoclave in the phar- maceutical industry. The study was based on the principle of moist heat sterilization and Good Manufacturing Practice for Pharmaceutical Products （ Amended in 2010 ）. Some viewpoints and proposals for details of qualifications were presented. The purpose was to achieve the effect of the corret selection of type,stable operation, reliable performance and the desired sterilization effect.
出处
《药学研究》
CAS
2013年第9期551-553,共3页
Journal of Pharmaceutical Research
关键词
湿热灭菌设备
F0值
Autoclave
Good Manufacturing Practice for Pharmaceutical Products（Amended in 2010）
Qualifications
F0 value
