溶劑回收是原料藥生產過程中的關鍵工序。因在吸附、萃取、分離、干燥等作業(yè)工序中需使用大量有機溶劑，原料藥制造也隸屬于“溶劑使用”行業(yè)。原料藥工廠經常會進行溶劑回收及濃縮、蒸餾等工藝操作。此類操作中，不僅處理的料液內通常含有易燃易爆、有毒有害?；方M分，而且會進行加熱操作并通過蒸發(fā)產生氣相溶劑。如果料液受熱不均局部過熱，就會產生液溫沖高。如果溶劑氣體流動不暢和（或）冷凝不足，會產生氣壓沖高風險。本身就有一定危險性的料液還需加熱到較高的溫度，且易形成爆炸性氣體，如果是減壓濃縮、蒸餾，其破真空操作不當均會存在吸入空氣導致燃爆風險，故其危險性會進一步積聚增大。

　　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，位于英國曼徹斯特的一家小型溶劑回收公司ChemstarLimited發(fā)生爆炸，導致1人死亡、1人燒傷。直接原因?：蒸餾裝置冷凝器失去冷卻水，導致蒸汽進入環(huán)境，被周邊的鍋爐點燃。事故發(fā)生時，工廠的主供水路由于當地蓄水池排水而被切斷，工廠臨時從附近的河流供水。事故發(fā)生前幾天，臨時供水由于柴油泵和另一個未知的問題導致出現狀況。由于供水中斷，正己烷的蒸餾裝置發(fā)生爆炸。最初一員工在蒸餾房間內聞到強烈的蒸汽味道，隨即降低了蒸汽流量，并發(fā)現冷凝器供水中斷了。人們認為高溫鍋爐將正己烷蒸汽點燃并導致了爆炸。

　　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，日本某工廠的甲醇回收蒸餾塔發(fā)生爆炸，塔頂被炸飛，事故造成2人死亡、13人受傷。體系中的三氧化硫和甲醇生成硫酸甲酯，其再和過氧化氫反應生成過氧甲醇，在濃縮后發(fā)生分解爆炸。直接原因?體系中的三氧化硫和甲醇生成硫酸甲酯，其再和雙氧水反應生成過氧甲醇（CH3OOH),在濃縮后發(fā)生分解爆炸（超過60%在鐵質塔內被點燃而發(fā)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，美國俄亥俄州西卡羅爾頓一家危險廢棄物處理公司Veolia ES技術服務有限公司因高度可燃四氫呋喃（THF）氣體的泄漏發(fā)生火災爆炸事故，造成4名工人受傷，多處廠內建筑設施、周邊住宅和商業(yè)建筑受損。事故原因：THF溶劑混合物從損壞的罐體內溢出，形成可燃氣體，通風裝置存在缺少控制危險有毒氣體的設計缺陷；旁邊實驗操作樓內的兩座天然氣鍋爐最有可能是點火源。

　　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，東京板橋區(qū)一家藥品工廠發(fā)生溶劑泄漏并著火。東京都消防廳出動了包括化學反應部隊在內的33輛消防車參與滅火。爆炸的原因初步判斷是由于藥廠的一臺溶劑儲存罐發(fā)生了泄漏，溶劑與空氣接觸后發(fā)生了化學反應，引發(fā)了火災。

　　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.

　　對溶劑回收利用可能引入的風險進行分析，如溶劑相關雜質和使用此溶劑的反應步驟可能帶入的雜質的殘留和蓄積，需特別關注在中間體質量標準中研究未控制的雜質。應根據風險分析反應熱評估以及研究情況擬定嚴格的回收溶劑質量標準，提供標準限度制定依據。如必須使用回收溶劑，需明確回收溶劑使用的規(guī)則及輪次并提供相應的研究及驗證資料?。

　　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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