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Qualification of autoclave
Author(s): 
Pages: 551-553
Year: Issue:  9
Journal: Qilu Pharmaceutical Affairs

Keyword:  湿热灭菌设备2010版GMPF0值;
Abstract: 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.
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