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确定并建立最终灭菌的无菌制剂在灭菌过程中出现停电状况时的处理方法。采用在产品灭菌过程中人为断电进行模拟验证,结果发现:在停电时,通过采用后备电源给灭菌柜的监控系统提供不间断供电的方式,可使灭菌柜监控系统持续监控产品的灭菌状态并记录数据,并能够在一定时间内保持灭菌状态。验证得出结论:在正常生产过程中出现停电情况,通过采用后备电源给灭菌柜的监控系统提供不间断供电的方式,可使灭菌柜监控系统在外界停止供电的情况下,实现持续对正在灭菌的产品的状态监控、实时记录灭菌数据,并且不用将灭菌的控制模式由自动切换到手动,避免了F_0值的归零,从而使F_0值的计算得以延续。在保温和密封良好的情况下,在一定的时间范围内被灭菌产品能维持灭菌状态,并达到灭菌要求。
Determine and establish the method of disposal of the final sterilized sterile preparation in the event of a blackout during sterilization. In the process of product sterilization artificial off simulation, the results showed that: in the blackout, through the use of backup power supply to the monitoring system of the sterilization cabinet to provide uninterrupted power supply, sterilizer monitoring system can continuously monitor the product Sterilization status and record data, and be able to maintain sterilization status within a certain period of time. Verify that the power outage in the normal production process, through the use of backup power supply to the monitoring system of the sterilization chamber to provide uninterrupted power supply, sterilizer monitoring system can be stopped in the external power supply circumstances, to achieve sustained The state of the product being sterilized is monitored, the sterilization data is recorded in real time, and the sterilization mode is not automatically switched from manual to manual, eliminating the need to reset the F_0 value so that the calculation of the F_0 value can be continued. In a good insulation and sealed the case, in a certain period of time to be sterilized products to maintain sterilization, and sterilization requirements.