由于氯化反应岗位使用的冰块对R1503罐搪玻璃搅拌桨有碰撞磨损，导致搅

Because the ice cubes used in the chlorination reaction post collided and abraded the glass-lined agitating paddles of the R1503 tank, the surface enamel of the agitating paddles fell off. The post operator did not check carefully after the cleaning, which caused damage to the R1503 tank mixing paddle and was not discovered in time. <br><br>Because the stirring blade of the R1503 tank only involves the shedding of the surface enamel, the material contacted by the material liquid is still glass-lined, and the material liquid does not come into contact with the iron material of the glass-lined inner layer. And this material liquid will not react with the glass liner, and in the subsequent post will be subjected to dichloromethane extraction, activated carbon decolorization, anhydrous sodium sulfate dehydration and then filtered through the filter and other operations. By looking at the batch production records of 1035-A191107 to 1035-A191201 related to this deviation, the filter bags were intact before and after filtration. Following the chlorination reaction post, there are also the cyclization reaction post and the refining post. The refining post has a filtration operation of 0.45um membrane. These processes can remove the enamel mixed with the material liquid. Therefore, the material liquid can effectively remove the enamel falling off the stirring blade of the R1503 tank through the above processing steps. Because glass-lined will not dissolve in all materials used in the production of cyclophosphamide, the risk is controllable. For details, see D-TZ-API-205-19004-R R1503 Ice Separation Tank Deviation Survey and Risk Assessment Report. <br><br>1. Repair the inner surface of the glass-lined agitating paddle of the R1503 tank according to H3-TM-10102 maintenance rules of the glass-lined reaction tank, and conduct the electric spark test. <br>2. Check other glass-lined reaction tanks of the cyclophosphamide production line to see if the reactor is damaged. <br>3. Train operators in accordance with H0-SOP-20074 equipment maintenance management procedures, emphasizing: after each cleaning, record whether the glass-lined surface is damaged. <br>4. Revise the H3-MPD-10116-01 Cyclophosphamide chlorination reaction post operation rules and H3-MPD-10116-R01 ~ R05 cyclophosphamide batch production record (Y36), add: add R1503 can glass lined before production Check the surface for damage. And train relevant personnel.

Due to the chlorination reaction post used ice on r1503 cans of glass mixing paddles have collision wear, resulting in the mixing paddle surface enamel off. Post operators after the cleaning, not carefully examined, resulting in R1503 cans of mixer paddle breakage was not found in time. <br><br>As R1503 cans of stirring paddles only involve surface enamel off, the material contact with the material is still enamel glass, the material liquid is not in contact with the iron material of the inner layer of the glass. This liquid and glass will not react, and in the follow-up post will be through dichloromethane extraction, activated carbon decolorization, waterless sodium sulfate dehydration and then filtered through the filter and other operations. By viewing the seven batch production records related to this deviation from 1035-A19107 to 1035-A191201, the filter bag before and after filtration is intact. Chlorine reaction post follow-up, there are ring reaction posts and refined posts, refined posts have 0.45um membrane filtration operation, these processes can be mixed with enamel to remove. Therefore, the liquid through the above processing process can effectively remove R1503 cans of stirring paddle off enamel. Since the glass does not dissolve in all materials used in the production of cyclophosphamide, the risk is manageable. See D-TZ-API-205-19004-R1503 Ice Tank Deviation Survey and Risk Assessment Report.<br><br>1. In accordance with the H3-TM-10102 glass reaction tank maintenance procedures to R1503 can glass mixer inner surface to repair, and electric spark test.<br>2. Check the other glass reaction tanks of the cyclophosphamide production line to see if the reactor is damaged.<br>3. The operator in accordance with H0-SOP-20074 equipment maintenance management procedures for the corresponding training, emphasizing: after each cleaning, the glass surface is not damaged to record.<br>4. Revising the operating procedures of H3-MPD-10116-01 ring phosphamide chlorination reaction and h3-MPD-10116-R01-R01-R05 ring phosphamide batch production record (Y36) to increase: pre-production, r1503 cans of glass surface damage is detected. And to train relevant personnel.

Due to the collision and wear of the ice used in the chlorination reaction post on the r1503 tank glass lined agitator paddle, the enamel on the surface of the agitator paddle fell off. After cleaning, the post operators did not check carefully, resulting in the damage of r1503 tank agitator paddle which was not found in time.<br>Because r1503 tank agitator only involves enamel falling off on the surface, the material in contact with the liquid is still glass lined, and the liquid is not in contact with the iron material in the inner layer of glass lined. This material solution will not react with glass lining, and will be extracted by dichloromethane, decolorized by activated carbon, dehydrated by anhydrous sodium sulfate and filtered by filter in subsequent posts. By checking the seven batch production records of 1035-a191107 to 1035-a191201 related to the deviation, the filter bags were intact before and after filtration. After the chlorination reaction post, there are also the cyclization reaction post and the refining post. The refining post has the filtration operation of 0.45um membrane, which can remove the enamel mixed with the material liquid. Therefore, the enamel of r1503 can be effectively removed by the above treatment process. Since the glass lining will not dissolve in all materials used in cyclophosphamide production, the risk is controllable. See d-tz-api-205-19004-r r1503 deviation investigation and risk assessment report for details.<br>1. According to h3-tm-10102 glass lined reaction tank maintenance procedures, repair the inner surface of r1503 tank glass lined agitator paddle, and conduct electric spark test.<br>2. Check other glass lined reaction tanks of cyclophosphamide production line to see if the reactor is damaged.<br>3. Train the operators according to the use and maintenance management procedure of h0-sop-20074 equipment, and emphasize: record whether there is any damage on the glass lining surface after each cleaning.<br>4. Revise h3-mpd-10116-01 cyclophosphamide chlorination post operation procedure and h3-mpd-10116-r01 ~ R05 cyclophosphamide batch production record (y36), add: before production, test whether there is damage on the glass lining surface of r1503 tank. And train the relevant personnel.<br>