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Design of a Continuous Solvent Recovery System for End-to-End Integrated Continuous Manufacturing of Pharmaceuticals
Organic Process Research & Development ( IF 3.4 ) Pub Date : 2020-06-12 , DOI: 10.1021/acs.oprd.0c00092
Brianna T. Shores 1 , Peter E. Sieg 1 , Ana T. Nicosia 1 , Chuntian Hu 1 , Stephen C. Born 1 , Khrystyna Shvedova 1 , Ridade Sayin 1 , Christopher J. Testa 1 , Wei Wu 1 , Bayan Takizawa 1 , Sukumar Ramanujam 2 , Salvatore Mascia 1
Affiliation  

Disadvantages of the traditional batch process have encouraged the pharmaceutical industry to explore continuous manufacturing, including end-to-end approaches, such as integrated continuous manufacturing (ICM). As the pharmaceutical industry is relatively solvent-intensive, solvent recovery is necessary to achieve the goal of sustainable manufacturing. A simple vapor–liquid equilibrium (VLE) setup was designed, and its reliability was assessed, from which the VLE data for a two-solvent system were obtained and, accordingly, the distillation columns were designed. The recovered solvent purities were >99.9 wt % for the first solvent (Solvent 1) and >99.8 wt % for the second solvent (Solvent 2), and the recovery yields were 94.9% and 98.3%, respectively. From the E-factor analysis, approximately 30% less waste was generated in the ICM process compared with a corresponding batch process. After integration of the solvent recovery system, the E-factors for both the batch and ICM processes decreased significantly, from 1.63 to 0.29 and from 0.77 to 0.21, respectively.

中文翻译:

端到端药品连续生产的连续溶剂回收系统设计

传统批量处理的缺点鼓励了制药行业探索连续制造,包括端到端方法,例如集成连续制造(ICM)。由于制药行业是溶剂密集型的,因此溶剂回收对于实现可持续生产的目标是必要的。设计了一种简单的气液平衡(VLE)装置,并对其可靠性进行了评估,由此获得了两溶剂系统的VLE数据,并因此设计了蒸馏塔。对于第一溶剂(溶剂1),回收的溶剂纯度为> 99.9wt%,对于第二溶剂(溶剂2),回收的溶剂纯度为> 99.8wt%,回收率分别为94.9%和98.3%。根据电子因子分析,与相应的批处理过程相比,ICM过程中产生的废物减少了约30%。整合溶剂回收系统后,分批和ICM工艺的E因子均显着降低,分别从1.63降低至0.29和从0.77降低至0.21。
更新日期:2020-06-12
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