溶剂回收是原料药生产过程中的关键工序。因在吸附、萃取、分离、干燥等作业工序中需使用大量有机溶剂，原料药制造也隶属于“溶剂使用”行业。原料药工厂经常会进行溶剂回收及浓缩、蒸馏等工艺操作。此类操作中，不仅处理的料液内通常含有易燃易爆、有毒有害危化品组分，而且会进行加热操作并通过蒸发产生气相溶剂。如果料液受热不均局部过热，就会产生液温冲高。如果溶剂气体流动不畅和（或）冷凝不足，会产生气压冲高风险。本身就有一定危险性的料液还需加热到较高的温度，且易形成爆炸性气体，如果是减压浓缩、蒸馏，其破真空操作不当均会存在吸入空气导致燃爆风险，故其危险性会进一步积聚增大。

　　Solvent recovery is a critical process in the production of active pharmaceutical ingredients. Due to the extensive use of organic solvents in processes such as adsorption, extraction, separation, and drying, the manufacturing of active pharmaceutical ingredients also belongs to the "solvent use" industry. Raw material factories often carry out solvent recovery, concentration, distillation and other process operations. In such operations, not only does the processed liquid usually contain flammable, explosive, toxic, and hazardous chemical components, but it also undergoes heating operations and produces gas-phase solvents through evaporation. If the material liquid is heated unevenly and locally overheated, it will cause a liquid temperature surge. If the flow of solvent gas is not smooth and/or the condensation is insufficient, there will be a high risk of pressure surge. Materials with inherent danger need to be heated to higher temperatures and are prone to forming explosive gases. Improper vacuum breaking operations such as vacuum concentration and distillation can lead to the risk of inhaling air and causing explosions, thus further increasing their danger.

　　1981年9月6日，位于英国曼彻斯特的一家小型溶剂回收公司ChemstarLimited发生爆炸，导致1人死亡、1人烧伤。直接原因?：蒸馏装置冷凝器失去冷却水，导致蒸汽进入环境，被周边的锅炉点燃。事故发生时，工厂的主供水路由于当地蓄水池排水而被切断，工厂临时从附近的河流供水。事故发生前几天，临时供水由于柴油泵和另一个未知的问题导致出现状况。由于供水中断，正己烷的蒸馏装置发生爆炸。最初一员工在蒸馏房间内闻到强烈的蒸汽味道，随即降低了蒸汽流量，并发现冷凝器供水中断了。人们认为高温锅炉将正己烷蒸汽点燃并导致了爆炸。

　　On September 6, 1981, Chemstar Limited, a small solvent recovery company in Manchester, England, exploded, resulting in one death and one burn. Direct cause? The condenser of the distillation unit loses cooling water, causing steam to enter the environment and be ignited by surrounding boilers. When the accident occurred, the main water supply channel of the factory was cut off due to the drainage of the local reservoir, and the factory temporarily supplied water from nearby rivers. A few days before the accident, the temporary water supply was affected by a diesel pump and another unknown issue. Due to water supply interruption, the distillation unit for n-hexane exploded. At the beginning, the employee smelled a strong steam smell in the distillation room, immediately reduced the steam flow, and found that the water supply to the condenser was interrupted. People believe that the high-temperature boiler ignited n-hexane steam and caused an explosion.

　　1991年，日本某工厂的甲醇回收蒸馏塔发生爆炸，塔顶被炸飞，事故造成2人死亡、13人受伤。体系中的三氧化硫和甲醇生成硫酸甲酯，其再和过氧化氢反应生成过氧甲醇，在浓缩后发生分解爆炸。直接原因?体系中的三氧化硫和甲醇生成硫酸甲酯，其再和双氧水反应生成过氧甲醇（CH3OOH),在浓缩后发生分解爆炸（超过60%在铁质塔内被点燃而发生爆炸）

　　In 1991, an explosion occurred in the methanol recovery distillation tower of a factory in Japan, causing the top of the tower to be blown away, resulting in 2 deaths and 13 injuries. Sulfur trioxide and methanol in the system generate methyl sulfate, which then reacts with hydrogen peroxide to produce peroxymethanol. After concentration, it undergoes decomposition and explosion. Direct cause? Sulfur trioxide and methanol in the system generate methyl sulfate, which then reacts with hydrogen peroxide to produce peroxymethanol (CH3OOH). After concentration, it decomposes and explodes (over 60% of which is ignited in an iron tower and explodes)

　　2009年5月4日，美国俄亥俄州西卡罗尔顿一家危险废弃物处理公司Veolia ES技术服务有限公司因高度可燃四氢呋喃（THF）气体的泄漏发生火灾爆炸事故，造成4名工人受伤，多处厂内建筑设施、周边住宅和商业建筑受损。事故原因：THF溶剂混合物从损坏的罐体内溢出，形成可燃气体，通风装置存在缺少控制危险有毒气体的设计缺陷；旁边实验操作楼内的两座天然气锅炉最有可能是点火源。

　　On May 4, 2009, Veolia ES Technical Services Co., Ltd., a hazardous waste management company located in West Carolina, Ohio, USA, experienced a fire and explosion accident due to the leakage of highly flammable tetrahydrofuran (THF) gas. Four workers were injured and multiple building facilities, surrounding residential and commercial buildings were damaged. Accident cause: THF solvent mixture overflowed from the damaged tank, forming flammable gas, and there was a design defect in the ventilation system that lacked control over hazardous and toxic gases; The two natural gas boilers in the adjacent experimental operation building are most likely to be ignition sources.

　　2024年1月9日，东京板桥区一家药品工厂发生溶剂泄漏并着火。东京都消防厅出动了包括化学反应部队在内的33辆消防车参与灭火。爆炸的原因初步判断是由于药厂的一台溶剂储存罐发生了泄漏，溶剂与空气接触后发生了化学反应，引发了火灾。

　　On January 9, 2024, a pharmaceutical factory in Itabashi ku, Tokyo experienced a solvent leak and caught fire. The Tokyo Metropolitan Fire Department deployed 33 fire trucks, including the Chemical Reaction Unit, to participate in extinguishing the fire. The preliminary determination of the cause of the explosion is that a solvent storage tank in the pharmaceutical factory leaked, and the solvent reacted chemically with air, causing a fire.

　　对溶剂回收利用可能引入的风险进行分析，如溶剂相关杂质和使用此溶剂的反应步骤可能带入的杂质的残留和蓄积，需特别关注在中间体质量标准中研究未控制的杂质。应根据风险分析反应热评估以及研究情况拟定严格的回收溶剂质量标准，提供标准限度制定依据。如必须使用回收溶剂，需明确回收溶剂使用的规则及轮次并提供相应的研究及验证资料?。

　　Analyze the potential risks associated with solvent recycling, such as solvent related impurities and residual and accumulated impurities that may be introduced during the reaction steps using this solvent. Special attention should be paid to studying uncontrolled impurities in intermediate quality standards. Strict quality standards for recycled solvents should be developed based on risk analysis, reaction heat assessment, and research findings, providing a basis for setting standard limits. If it is necessary to use recycled solvents, it is necessary to clarify the rules and cycles for the use of recycled solvents and provide corresponding research and verification materials?.

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