2019.10.26日10点38分，蔡海兵在对博来霉素1020-B19

At 10:38 on October 26, 2019, when Cai Haibing neutralized the batch of bleomycin 1020-B191004 ion exchange eluent, he found that the thermometer in the R2201a tank could not display the temperature. The process requires the neutralization temperature to be controlled at 5.0 ~ 15.0 ℃. <br><br>The most likely cause of this deviation is that the battery of the neutralization tank R2201a thermometer B-TT02-Y33-15 is soldered on the circuit board, and the battery cannot be replaced directly. Thermometer batteries are consumables. In long-term use, the battery power will slowly run out, resulting in the inability to display the temperature. <br><br>When the deviation is found, the neutralization tank R2201a is used to store the bleomycin extraction 1020-B191004 batch of T2201a, b ion transfer column eluent, ready for neutralization. The bleomycin process specification requires that the neutralization temperature be controlled at 5.0 to 15.0 degrees. <br>The staff of the metrology department confirmed that the battery of the B-TT02-Y33-15 digital thermometer was exhausted, and the battery could not be changed directly. In order not to affect production, the R2201b can thermometer B-TT02-Y33-14 of the same model and specification is used, and the battery has sufficient power. It is verified on April 28, 2018, and the validity period is until 2020.04.27. Within the valid period of verification, the temperature verification range Cover the range of 5.0 ~ 15.0 ℃, replace the B-TT02-Y33-15 digital thermometer for measuring the temperature of the neutralizing liquid in the neutralizing tank R2201a. <br>The thermometer probe is inserted into the thermometer sleeve of the glass-lined reaction tank. It does not directly contact with the material liquid in the tank, which has little effect on the quality of the bleomycin ion exchange elution neutralization solution. At the same time, follow-up observation of the bleomycin The extraction batch (1020-B191004) neutralization solution yield and bleomycin A2, B2 gel eluent, to see if the purity meets the requirements. <br><br>1. Remove the B-TT02-Y33-15 thermometer from the battery depletion neutralization tank R2201a. <br>2. Replace the R2201b tank B-TT02-Y33-14 thermometer with the R2201a tank. <br>3. Replace the R2201a digital thermometer in the neutralization tank with a thermometer that can replace the battery.<br>4. Follow-up observation of the bleomycin extraction batch (1020-B191004) neutralization liquid yield and bleomycin A2, B2 gel eluent to see if the purity meets the requirements. <br>5. Check whether there is other equipment in the bleomycin extraction post (CH-490). It is not convenient to replace the thermometer of the battery, and replace it according to the results of the investigation.

At 10:38 p.m. on the 2019.10.26th, Cai Haibing was mid-way with the elution of the 1020-B191004 batch of ion exchange elutions, and found that the thermometer of the R2201a tank could not show the temperature. The process requires a medium-temperature control of 5.0 to 15.0 degrees C. <br><br>The most likely cause of this deviation is that the medium-to-tank R2201a thermometer B-TT02-Y33-15 battery is soldered on the board and cannot be replaced directly. The thermometer battery is a consumable, in the long-term use of the battery will slowly drain, resulting in the temperature can not be displayed. <br><br>When the deviation is found, the medium-sum tank R2201a is used to store Bolamycin extraction 1020-B191004 batch T2201a, b-ion junction column elution, ready to be moderated. Bolemycin process procedures require a temperature control of 5.0 to 15.0 degrees.<br>The metering department confirmed that the Battery of the B-TT02-Y33-15 digital thermometer was empty and could not be mixed directly. In order not to affect production, the same model of the same specifications of R2201b tank thermometer B-TT02-Y33-14, battery power sufficient, 2018.04.28 to check, valid until 2020.04. 27, within the validity period of the school test, the temperature verification range covers the use of 5.0 to 15.0 degrees C range, replacing the B-TT02-Y33-15 digital thermometer for measuring the medium and tank R2201a's medium-liquid temperature.<br>The thermometer probe is inserted into the tube of the glass reaction tank thermometer, does not come into direct contact with the tank infusion, has a small impact on the elution and fluid quality of bolemycin ion exchange, while follow-up follow-up observation of the Bolamycin extraction batch (1020-B191004) and liquid yield and bolrepmycin A2, B2 gel elution liquid, to see if the purity meets the requirements.<br><br>1. Remove the B-TT02-Y33-15 thermometer of the tank R2201a, which is depleted.<br>2. Replace the R2201b can B-TT02-Y33-14 thermometer with the R2201a tank.<br>3. Replace the rinted r2201a digital thermometer with a thermometer that can replace the battery.<br>4. Track and observe the bolamycin extraction batch (1020-B191004) and the liquid yield and Bolamycin A2, B2 gel elution, to see if the purity meets the requirements.<br>5. Check whether the other equipment of the Boralymycin extraction post (CH-490) is not convenient to replace the battery thermometer, depending on the results of the inspection to replace.

At 10:38 on 2019.10.26, when neutralizing the ion exchange eluent of bleomycin 1020-B191004 batch, Cai Haibing found that the thermometer of R2201a tank could not display the temperature. The neutralization temperature should be controlled at 5.0 ~ 15.0 ℃.<br>The most likely cause of the deviation is that the battery of r2201a thermometer b-tt02-y33-15 of neutralization tank is welded on the circuit board and cannot be replaced directly. Thermometer battery is a kind of consumable. In the long-term use, the battery power will be exhausted slowly, resulting in the failure to display the temperature.<br>When the deviation is found, r2201a neutralization tank is used to store 1020-b191004 batches of t2201a and B ion exchange column eluent for bleomycin extraction and prepare for neutralization. The neutralization temperature of bleomycin is controlled at 5.0 ~ 15.0 ℃.<br>The personnel of measurement department confirmed that the battery of b-tt02-y33-15 digital thermometer was exhausted, and the battery could not be mixed directly. In order not to affect the production, the thermometer b-tt02-y33-14 of r2201b tank with the same model and specification is used, and the battery power is sufficient. It will be calibrated on April 28, 2018, and the validity period is until April 27, 2020. Within the validity period of qualified calibration, the temperature verification range covers the range of 5.0 ~ 15.0 ℃, and the digital thermometer b-tt02-y33-15 is replaced to measure the neutralization liquid temperature of r2201a neutralization tank.<br>The probe of the thermometer is inserted into the thermometer casing of the glass lining reaction tank, which is not directly contacted with the liquid in the tank, and has little effect on the quality of the medium of the bleomycin ion exchange eluent. At the same time, follow up observation of the yield of the bleomycin extraction batch (1020-B191004) and the bleomycin A2, B2 gel eluent, and see whether the purity meets the requirements.<br>1. Remove b-tt02-y33-15 thermometer of neutralization tank r2201a when the battery is exhausted.<br>2. Replace b-tt02-y33-14 thermometer of r2201b tank with r2201a tank.<br>3. Replace the r2201a digital thermometer of neutralization tank with a thermometer that can replace the battery.<br>4. observe and observe bleomycin extraction batch (1020-B191004) neutralization liquid yield and bleomycin A2, B2 gel eluent to see whether the purity meets the requirements.<br>5. Check whether other equipment of bleomycin extraction post (ch-490) is inconvenient to replace the battery thermometer, and replace it according to the troubleshooting results.<br>