通过对温湿度记录仪的模块和传感器进行更换，发现温湿度记录仪仍然显示：温

By replacing the module and sensor of the temperature and humidity recorder, it was found that the temperature and humidity recorder still showed: temperature 0.0 ℃, humidity 0.0%, to eliminate the abnormal conditions caused by the damage of the temperature and humidity recorder module and the sensor; Change to the original temporary power distribution box, no abnormality after trial operation, and then replace the module and sensor of the newly replaced temperature and humidity recorder with the old temperature and humidity recorder, the data is still normal after 15 days of operation, so this caused The most likely cause of the secondary deviation is that the newly replaced power line of the temperature and humidity recorder is subject to electromagnetic interference generated during the operation of the three-in-one frequency converter in the clean area of ​​imipenem, causing the power line to be abnormal. <br><br>After the workshop staff reopened the temperature and humidity recorder, they can collect data normally. After viewing the historical curve, it is found that the curve data is displayed as 0.0 during 2019.12.17 14: 20 ~ 2019.12.18 08:00, the data is lost, after the deviation occurs High-frequency recording of the temperature and humidity of the intermediate storage room (2 hours / time) until the deviation survey is completed. When this deviation occurs, the materials stored in the intermediate temporary storage room on the first floor of Building Y73, Workshop 210 are imipenem deprotection and cilastatin hydrolyzed sodium salt, both of which are within the validity period, and the storage conditions are all room temperature, the temperature and humidity The data collected by the recorder is only for recording, not for alarm. Therefore, the risk of the temperature and humidity recorder failing to collect data in a short time is low, and the temperature and humidity curves are printed during the troubleshooting process. Sistatin sodium hydrolyzed sodium salt 2017-HB191203 and 2017-HB191204 have been produced into 2017-B191205 batches, and some of the imipenem deprotected batches have been produced into 2065-200101 batches. The product quality is not abnormal, and follow-up tracking involves Other batches of imipenem. For details, please refer to D-TZ-API-210-19006-RY73 intermediate storage room temperature and humidity recorder deviation survey and risk assessment report. <br><br>Release of cilastatin sodium (20-02-18); production of deprotected imipenem to finished imipenem, release (20-02-20) (20-03-12) (20-4-22 ) <br><br>CP-TZ-API-D-TZ-210-19006-20001: Replace the power supply circuit of the temperature and humidity recorder to the wiring above the main power switch in the original temporary power distribution box, and make a warning sign.

By replacing the modules and sensors of the temperature and humidity recorder, it is found that the temperature and humidity recorder is still displayed: temperature 0.0 degrees C, humidity 0.0%, excluding abnormal conditions caused by the damage of the temperature and humidity recorder module and sensor; After the replacement of the temperature and humidity recorder module and sensor replaced with the old temperature and humidity recorder, the data is still normal after 15 days of operation, so the most likely cause of this deviation is that the temperature and humidity recorder's newly replaced power line is subject to electromagnetic interference caused by the operation of the three-in-one drive in the amine-penan clean zone, resulting in abnormal power supply lines.<br><br>After re-opening the temperature and humidity recorder, the workshop personnel can collect the data normally, after viewing the historical curve, found that in 2019.12.17 14:20 to 2019.12.18 08:00, the curve data display is 0.0, data loss, after the deviation of the intermediate staging chamber for high-frequency recording (2 hours / times) until the end of the deviation investigation. When this deviation occurred, 210 workshop Y73 first floor intermediate siloroom storage materials for amine-penananan anti-protector and sodium sodium hydrolysis sodium salt, both in the validity period, the preservation conditions are room temperature, the temperature and humidity recorder collected data only for records, do not alarm, so the temperature and humidity recorder in a short period of time failed to collect data risk is low, and in the process of troubleshooting have printed temperature and humidity. Sistatin sodium hydrolysissed sodium salt 2017-HB191203 and 2017-HB191204 has been produced into 2017-B191205 batches, part of the amine-penananantis protected batch has been produced into 2065-200101 batch, product quality is no abnormal, follow-up tracking involving other batches of amine-nam. See D-TZ-API-210-19006-RY73 intermediates for staging room temperature humidity recorder deviation survey and risk assessment report.<br><br>Sistatin eiba (20-02-18); amine-penanan protector produced to amine-penanan finished product, release (20-02-20) (20-03-12) (20-4-22) <br><br>CP-TZ-API-D-TZ-210-19006-20001: Replace the temperature and humidity recorder power line to the terminal above the general power switch in the original temporary power distribution box and make a warning sign.

Through replacing the module and sensor of the temperature and humidity recorder, it is found that the temperature and humidity recorder still displays: temperature 0.0 ℃, humidity 0.0%, eliminate the abnormal conditions caused by the damage of the module and sensor of the temperature and humidity recorder; change the power circuit of the temperature and humidity recorder to the original temporary power distribution box, and there is no abnormality after the test run, and then replace the module and sensor of the newly replaced temperature and humidity recorder with the old temperature and humidity recorder, the data is still normal after 15 days of operation, so the most likely cause of the deviation The new power line of the temperature and humidity recorder is interfered by the three in one inverter in the clean area of imipenem, which makes the power line abnormal.<br>After the workshop personnel reopened the temperature and humidity recorder, the data can be collected normally. After checking the historical curve, it is found that during 14:20 ~ 08:00 on December 17, 2019, the curve data is displayed as 0.0, and the data is lost. In case of deviation, the temperature and humidity in the intermediate temporary storage room shall be recorded at high frequency (2 hours / time) until the deviation investigation is completed. In case of such deviation, the materials stored in the intermediate temporary storage room on the first floor of building Y73 of workshop 210 are imipenem deprotection and cilastatin sodium hydrolysate sodium salt, both of which are within the validity period, and the storage conditions are room temperature. The data collected by the temperature and humidity recorder is only for recording and no alarm. Therefore, the risk that the temperature and humidity recorder fails to collect data in a short period of time is low, and they are all marked in the process of troubleshooting Printing temperature and humidity curve. The hydrolysis sodium salt of cilastatin 2017-hb191203 and 2017-hb191204 have been produced into 2017-b191205 batches, some imipenem deprotection batches have been produced into 2065-200101 batches, and the product quality is normal. Follow up tracking involves other batches of imipenem. For details, please refer to deviation investigation and risk assessment report of temporary storage room temperature humidity recorder in building d-tz-api-210-19006-ry73.<br>Release of cilastatin sodium (20-02-18); production of imipenem deprotection to imipenem finished product, release (20-02-20) (20-03-12) (20-4-22)<br>Cp-tz-api-d-tz-210-19006-20001: replace the power line of temperature and humidity recorder to the connection above the main power switch in the original temporary power distribution box, and make warning signs.<br>