2019年05月09日上午08时55分，美罗培南粗品（F13）岗位人员

At 8:55 am on May 9, 2019, Pan Bo, the staff of the crude meropenem (F13) post, prepared the crude meropenem (F13) (batch: 2087-190503-4C) on the first floor south of Y77, and the hydrogenation reaction was completed. After that, it filtered the hydrogenation reaction liquid from the hydrogenation reaction tank H1001 through the filter H1001-1 to the crystallization tank H1003 for crystallization. During the filtration process, it found that there was feed material leakage at the temporary special meropenem pipeline connected to the filter, and Production requirements do not match. <br><br>The reason for this deviation is that the post operators Ye Xiaobing and Pan Bo did not check whether the gaskets were intact after the temporary pipeline cleaning was completed and before use, and H3-SOP-65161-11 Y77 Building Merlot Penan crude product post operation rules It is not clearly specified that the gasket must be checked for intact before using the temporary pipeline, resulting in the use of damaged gaskets in the production, so that the liquid at the interface between the filter and the temporary pipeline seeps out. <br><br>This deviation occurs because the post operator did not check whether the gasket is intact after the temporary pipeline cleaning is completed and before use, resulting in the seepage of the liquid at the interface between the filter and the temporary pipeline, but the seepage of the material at the beginning of filtration It was discovered, and the staff immediately stopped filtering until the new gasket was replaced, and the filtration was restarted. During this process, the feed liquid was protected by nitrogen and the time to replace the new gasket was very short, so the crude meropenem (F13) will not be affected. Quality affects. Follow-up tracking yield, after the end of the discharge at 11:38, 2019.05.09, the crude product of meropenem (F13) was 20.3Kg, the yield was 60.90%, which was within the normal range. <br><br>1. Take this deviation as an example to train employees on the job, emphasizing that the gasket of the temporary pipeline is checked after the cleaning is completed and before use, and if there is damage, replace the new gasket in time. <br>2. Revise the H3-SOP-65161-11 Y77 building meropenem crude product post operation rules, clearly stipulate that the gasket must be checked before using the temporary pipeline, otherwise, replace the new gasket in time.

On May 09, 2019, at 08:55 a.m., Pan Bo, a person in the F13 position of Meropinan Rough, conducted meropinan rough (F13) on the first floor south of Y77 (batch: 2087-- 190503-4C) when prepared, after the hydrogenation reaction is completed, the hydrogenation reaction fluid is filtered from the hydrogenation reactor tank H1001-1 to the crystalline tank H1003 for crystallization, during the filtration process, It found that the temporary Meropinan special line connected to the filter had liquid seeping out, which did not meet the production requirements. <br><br>The reason for this deviation is that the post operator Ye Xiaobing and Pan Bo in the temporary pipe cleaning after and before the use of the gasket is not intact inspection, and H3-SOP-65161-11 Y77 Merropnan crude post operating procedures do not clearly provide for the use of temporary lines must be checked gasket shims intact, resulting in the use of damaged gaskets in production, so that the filter and temporary line interface liquid seeping out. <br><br>The deviation occurs because the post operator after the temporary line cleaning and before the use of the gasket is not intact inspection, resulting in the filter and temporary line interface material seepage, but the material fluid seepage at the beginning of the filtration is found, and the post personnel immediately stop filtration until the replacement of the new gasket after the restart of filtration, in the process the liquid has gas nitrogen protection and replace the new gasket for a short time, so it will not affect the quality of the Merofinan crude (F13). Follow-up follow-up yield, at 2019.05.09 11:38 after the end of the discharge, obtained the Merofinan crude (F13) 20.3Kg, the yield of 60.90%, in the normal range.<br><br>1. Take this deviation as an example, train the staff, emphasizing that after cleaning and before use, check whether the gaskets of temporary lines are in tact, if there is damage, replace the new gaskets in a timely manner.<br>2. Revise H3-SOP-65161-11 Y77 Merropinan rough post operating procedures, clearly stipulates that before the use of temporary lines must check the gasket is intact, otherwise, replace the new gasket in a timely manner.

At 08:55 a.m. on May 9, 2019, pan Bo, a staff member of meropenem rough product (f13) post, was preparing meropenem rough product (f13) (batch: 2087-190503-4c) on the first floor south of y77. After the hydrogenation, he filtered the hydrogenation liquid from hydrogenation tank h1001 to crystallization tank h1003 through filter h1001-1 for crystallization. During the filtration, he found that the liquid connected with the filter The temporary meropenem special pipeline has liquid seepage, which is inconsistent with the production requirements.<br>The reason for the deviation is that ye Xiaobing and pan Bo did not check whether the gasket was in good condition after cleaning the temporary pipeline and before using, and h3-sop-65161-11 The operation specification of meropenem rough product post in building y77 does not clearly stipulate that the gasket must be checked before using the temporary pipeline, resulting in the use of damaged gasket in production, which makes the material liquid at the interface between the filter and the temporary pipeline seep out.<br>This deviation occurs because the post operator did not check whether the gasket was in good condition after the cleaning of the temporary pipeline and before use, resulting in the leakage of the feed liquid at the interface between the filter and the temporary pipeline, but the leakage of the feed liquid was found at the beginning of the filtration, and the post operator immediately stopped the filtration until the new gasket was replaced, and started the filtration again. In this process, the feed liquid was protected by nitrogen and replaced The time of new gasket is very short, so it will not affect the quality of meropenem rough product (f13). After the follow-up tracking yield, 20.3kg of meropenem crude product (f13) was obtained at 11:38, May 9, 2019, with a yield of 60.90%, within the normal range.<br>1. Take this deviation as an example, train the post staff, emphasize to check whether the gasket of the temporary pipeline is in good condition after cleaning and before use, and replace the gasket in time in case of any damage.<br>2. Revise the operation procedures of meropenem rough product post in building h3-sop-65161-11 y77, and make clear that it is required to check whether the gasket is in good condition before using the temporary pipeline, otherwise, replace the gasket in time.