验证(Validation)是美国 GMP 中的一个术语。工序验证(Process Validation)即对工序的工艺条件及设备进行检验和证明,予以科学的评价,以确保产品质量。注射剂灭菌设备是保证注射剂质量的重要设备。美国注射剂学会制订了“蒸气灭菌工序验证方法”。本文介绍其中有关灭菌设备 Validation is a term in GMP in the United States. Process Validation (Process Validation) that the process conditions and equipment testing and certification, to be scientifically evaluated to ensure product quality. Injectable sterilizing equipment is an important equipment to ensure the quality of injection. American Institute of Injectors developed a “steam sterilization process validation method.” This article describes one of the sterilization equipment