2019年07月29日13时10分，张桐在Y35幢二楼菌种设备室巡查时

At 13:10 on July 29, 2019, Zhang Tong found that the temperature of the 061103-103F-0005 biochemical incubator instrument showed a temperature of 25.6 ° C during the inspection of the bacteria equipment room on the second floor of the Y35 building, and the process range of the equipment was 30 ° C ~ 35 ℃. <br><br>The root cause of this deviation is that the biochemical incubator has been running for a long time, and the heater has been working for a long time and has been damaged, which is an accident. <br><br><br>The deviation device is only used for the cultivation of culture monitoring petri dishes in the clean area of ​​the bacteria room. After asking the operator, confirm that the total duration of the culture temperature deviating from the required range (30 ℃ ~ 35 ℃) does not exceed 2 hours, and extend the culture time of the batch of petri dishes involved in the deviation by 2 hours, and the follow-up environmental monitoring results meet the requirements. The deviation relates to the sampling interval of the environmental monitoring plate. The relevant production operation is only daunorubicin 1046-D190708 batches into the production seed shake flask, and the results of the seed liquid broth culture of this batch are tracked and tested to be qualified. The items in 061103-103F-0005 biochemical incubator are transferred to the central control room biochemical incubator 061103-205a-0001 for cultivation, which does not affect the normal operation of the biochemical incubator in the central control room. The articles stored in batches in separate storage will not affect each other. Therefore, the risk of this deviation affecting product quality can be controlled. <br><br>1. Equipment personnel repair 061103-103F-0005 biochemical incubator heater. <br>2. Track the temperature of the 061103-103F-0005 biochemical incubator after three days of maintenance, and then put it into use if it meets the requirements. <br>3. Continue to track the operation of 061103-103F-0005 biochemical incubator for 1 month to see if the temperature is normal (temperature requirement 30-35 ℃).

On July 29, 2019, at 13:10, Zhang Wei, while inspecting y35 second-floor bacteria equipment room, found that the 061103-103F-0005 biochemical incubator meter showed a temperature of 25.6 degrees C, and the process range of the equipment was 30 degrees C to 35 degrees C. <br><br>The root cause of this deviation is: biochemical incubator long-term operation, heater long-term operation and damage, as a chance.<br><br>The deviation device is only used for the cultivation of environmental monitoring petri dishes in the clean area of the strains. Upon enquiry, the operator was asked to confirm that the total duration of the deviation of the culture temperature from the required range (30 degrees C to 35 degrees C) was not more than 2 hours, the deviation involving the batch of petri dishes was extended by 2 hours, and the follow-up follow-up environmental monitoring results were in line with the requirements. The deviation involves the sampling range of the environmental monitoring flat dish, the relevant production operation is only the soft erythromycin 1046-D190708 batch into the production seed shaker, tracking and detecting the batch of seed liquid broth culture results are qualified. 061103-103F-0005 Biochemical incubator items transferred to the central control room biochemical incubator 061103-205a-0001 culture, does not affect the normal operation of the central control room biochemical incubator, the contents of the incubator stored separately will not affect each other. Therefore, the deviation affects the product quality risk under control. <br><br>1. Equipment personnel repair 061103-103F-0005 biochemical incubator heater.<br>2. Track the temperature condition of 061103-103F-0005 biochemical incubator after three days of operation after maintenance, if the requirements are met and then put into use of the biochemical incubator.<br>3. Continue to track the operation of 061103-103F-0005 biochemical incubator for 1 month to see if the temperature is normal (temperature requirements 30-35 degrees C).

At 13:10 on July 29, 2019, Zhang Tong found that the instrument display temperature of 061103-103f-0005 biochemical incubator was 25.6 ℃, while the process range of the equipment was 30 ℃ ~ 35 ℃.<br>The root cause of the deviation is: the biochemical incubator runs for a long time, and the heater is in working state for a long time, which is accidental.<br>The deviation equipment is only used for the culture of the environmental monitoring dish in the clean area of the bacteria room. After questioning the operators, it was confirmed that the total time of culture temperature deviation from the required range (30 ℃ ~ 35 ℃) was no more than 2 hours, and the culture time of the batch involved in the deviation was extended for 2 hours, and the follow-up environmental monitoring results met the requirements. The deviation relates to the sampling range of the environmental monitoring plate. Only daunorubicin 1046-d190708 batch is put into the production seed shaker, and the culture result of the seed broth of this batch is qualified through the follow-up test. The articles in 061103-103f-0005 biochemical incubator are transferred to 061103-205a-0001 biochemical incubator in central control room for cultivation, which does not affect the normal operation of biochemical incubator in central control room, and the articles in incubator are stored separately in batches without mutual influence. Therefore, the risk of the deviation's impact on product quality can be controlled.<br>1. Equipment personnel maintain 061103-103f-0005 biochemical incubator heater.<br>2. Track the temperature of 061103-103f-0005 biochemical incubator for three days after maintenance, and put it into use if it meets the requirements.<br>3. Continue to track the operation of 061103-103f-0005 biochemical incubator for one month to see whether the temperature is normal (the temperature is required to be 30-35 ℃).<br>