2019年06月29日03时22分,看罐人员黄莉发现替考拉宁2121-190602批次208罐溶氧为27.2%,低于工艺范围(工艺要求≥30的英语翻译

2019年06月29日03时22分,看罐人员黄莉发现替考拉宁2121-

2019年06月29日03时22分,看罐人员黄莉发现替考拉宁2121-190602批次208罐溶氧为27.2%,低于工艺范围(工艺要求≥30%),在03时31分溶氧升回工艺范围内,共持续9分钟。后又发生了两次类似溶氧低于工艺范围的情况,于05时32分溶氧升回工艺范围内,三次一共持续29分钟。此次偏差发生的根本原因是替考拉宁生产批次少,看罐人员缺乏实际操作经验,且相关SOP对中前期溶氧调节方法未做具体描述、不能有效指导岗位操作,导致在操作过程中溶氧流量调节幅度过大、调节压力时也未能保持罐压稳定,最终导致该次偏差发生。此次偏差发生在发酵培养周期的41-43h时,期间菌体耗氧需求开始减弱,且搅拌正常运转、空气流量仍在工艺范围内(工艺范围200~700m3/h),能提供一定的溶氧,短暂的低溶氧对菌体造成的伤害较小。1)偏差发生前后的发酵液检测结果(初步调查中已列出),皆符合替考拉宁中间体质量标准;2)最终放罐结果为:培养周期166h,发酵液呈棕黄色,菌丝衰老,趋于自溶,发酵单位 7144.5μg/ml,达到了放罐标准(周期130h-170h ,放罐条件:发酵液呈棕黄色,菌丝衰老,趋于自溶,发酵单位不在增加或增长缓慢,发酵单位≥6000μg/ml),故此处偏差对产品基本无影响。1.经过全面调查后得到的结论,修订H3-MPD-10325-02《替考拉宁发酵岗位操作规程》03版,加入替考拉宁中前期溶氧回升阶段调节溶氧的操作方法1).待溶氧回升至60%以上再进行调节;2).每次调节流量幅度小(建议不超过50m3/h);3).调节流量时应保证压力无明显波动(边开进空气阀门边关排气阀门)。2.对109车间Y10幢所有人员进行修订后H3-MPD-10325-02《替考拉宁发酵岗位操作规程》的培训,强调替考拉宁中前期溶氧回升阶段调节溶氧的操作方法,并以此偏差的空气流量操作作为反例,提高员工的认识。
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源语言: -
目标语言: -
结果 (英语) 1: [复制]
复制成功!
At 11:13 on June 28, 2019, personnel Wang Qiaoqin found the number of "sticky mouse board inspection and capture number" "Statistical Record" (H0-SOP-61005-R02) and the "Insecticidal Lamp Poor Checking, Detergent Capture Statistics" (H0-SOP-61005-R01) Fill in. According to the H0-SOP-61005 pest control and rodent control procedures, the pests must be checked and recorded every working day. <br><br>The reason for the deviation is that personnel Cheng Maosong learned the production of epirubicin from the old employees according to the leadership arrangement, and did not plan well for the work that needs to be completed that day, resulting in the omission of the inspection of the pest control in the workshop that day . <br><br>1. Sticky mouse board (No. N-Y50-101) and pest extinguisher lamp (No. M-Y50-101) are located at the doorway on the south side of the first floor of the Y50 building. The closed state, and the mouse door is placed at the same time. There is no production-related operation on the first floor on the day of June 27, 2019, and the risk of production impact can be controlled. Room 114 on the first floor for storing intermediates was closed and locked on the day of 2019.06.27, and two fire doors were required to enter the intermediate storage area. At the same time, the related materials and packaging were not abnormal, and the risk of impact on the materials can be control. 2. The sticky mouse board (No. N-Y50-101) was replaced on June 18, 2019. During the validity period (the sticky mouse board is valid for 15 days), the sticky mouse board is intact and there are only two mosquitoes on it. The number of insects and mosquitoes is less than the warning number of 15, which meets the requirements; the pest extinction lamp (number M-Y50-101) will be replaced on May 30, 2019, and the power grid will be cleaned on June 23, 2019, and intact, All are within the validity period, and there are no insects such as flies on it; check the history of the control of pest control in the workshop, and the number of pests meets the requirements of the H0-SOP-61005 pest control program. <br><br>1. Retrain H0-SOP-61005 Pest Control Program 01 for the relevant personnel, emphasizing that personnel should check and record the control situation of the pests in the workshop in time.
正在翻译中..
结果 (英语) 2:[复制]
复制成功!
On June 28, 2019, at 11:13, when the person was examining the control of the worm rats in the workshop, he found the "Sticky Rat Plate Inspection and Capture Statistics" of the Sticky Rat Board (No. N-Y50-101) on June 27, 2019. (H0-SOP-61005-R02) and insect control lamp (number M-Y50-101) "Insect control lamp detection, cleaner catch bug statistics record" (H0-SOP-61005-R01) was not filled out. According to the H0-SOP-61005 pest control procedures, the rodents are checked and recorded every working day. <br><br>The reason for the deviation is: personnel Cheng Maosong according to the leadership arrangement, with the old staff to learn the production of the table soft erythromycin, did not have a better plan for the work to be completed on the day, resulting in the day to check the workshop mouse control work was omitted. <br><br>1. Sticky mouse board (No. N-Y50-101) and insect control lamp (No. M-Y50-101) are located at the door on the south side of the first floor of Y50 buildings, from which there are two fire doors in the first floor production area, both closed, and the south door is also placed with a rat shield. 2019.06.27 On the first floor of the day no production-related operations, the impact of production risk can be controlled. The 114 room on the first floor for storing intermediates was locked on the same day of 2019.06.27, and required two fire doors to enter the intermediate storage area, while checking that the relevant material packaging is not abnormal, the impact of the risk of materials can be controlled. 2. Sticky rat board (No. N-Y50-101) was replaced on June 18, 2019, during the validity period (sticky mouse plate is valid for 15 days), sticky mouse plate is intact, there are only two mosquitoes, no other insects, the number of mosquitoes is less than the number of alert1 5, meet the requirements, insect control lamps (No. M-Y50-101) replaced on 30 May 2019, the power grid is cleaned on 23 June 2019, and intact, all within validity, without flies and other insects To view the historical mouse control records of the workshop, the number of insects and mice is in line with the Requirements of H0-SOP-61005 pest control procedures.<br><br>1. To carry out H0-SOP-61005 pest control procedure seismoidation retraining, emphasizing that personnel should timely check the control of the plant and make a good record.
正在翻译中..
结果 (英语) 3:[复制]
复制成功!
At 11:13 on June 28, 2019, when Wang qiaoqin was checking the pest control situation in the workshop, he found that the "statistic record of the pest control and capture number" (h0-sop-61005-r02) of the pest control board (No. n-y50-101) on June 27, 2019 and the "statistic record of the pest control and capture number of the detergent" (h0-sop-61005-r01) of the pest control light (No. m-y50-101) were not filled in. According to h0-sop-61005 management procedure for deratization, it is necessary to check and record every working day.<br>The reason for the deviation is that Cheng Maosong, a staff member, learned the production of epirubicin from the old staff according to the leader's arrangement, and failed to make a good plan for the work to be completed on the same day, which resulted in the omission of the inspection of insect and mouse control in the workshop on the same day.<br>1. The sticky rat board (No. n-y50-101) and the insect killing lamp (No. m-y50-101) are located at the south door of the first floor of building Y50. There are two fire doors entering the production area of the first floor from there, both of which are closed, and the south door is also provided with rat guard board. On June 27, 2019, there was no production related operation on the first floor, so the risk of production impact could be controlled. Room 114 on the first floor for intermediate storage was sealed and locked on June 27, 2019, and it needs to pass two fire doors to enter the intermediate storage area. At the same time, check that the packaging of related materials is normal, and the risk of material impact is controllable. 2. The glued rat board (No. n-y50-101) was replaced on June 18, 2019. During the validity period (15 days), the glued rat board was intact. There were only two mosquitoes on it, no other insects, and the number of mosquitoes was less than 15, which met the requirements. The insect killing lamp (No. m-y50-101) was replaced on May 30, 2019, and the power grid was cleaned on June 23, 2019, which was intact Within the validity period, there are no flies and other insects on it; check the historical pest control records of the workshop, and the number of pests and rats meets the requirements of h0-sop-61005 pest control management procedure.<br>1. Retraining the relevant personnel in h0-sop-61005 pest control management procedure version 01, emphasizing that the personnel should check the pest control situation in the workshop in time and make records.
正在翻译中..
 
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