Enhanced Recovery of Pharmaceutical Solvent driven by EPA Initiative

EPA 倡议推动制药溶剂的强化回收

• 批准号: 8522808
• 负责人: Daniel Campos
• 金额: $ 22.5万
• 依托单位: COMPACT MEMBRANE SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-12 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8522808
• 关键词: Acetone; Alcohol consumption; Alcohols; Amines; Chemicals; Custom; Dehydration; Drug Industry; Economics; Electron Transport; Environment; Environmental Impact; Event; Family; Fiber; Film; Goals; Health; Health Benefit; Heating; Human; Isopropanol; Ketones; Lead; Letters; Life; Life Cycle Stages; Manufacturer Name; Marketing; Membrane; Methanol; Names; Nature; Permeability; Pharmacologic Substance; Phase; Process; Public Health; Reaction; Reagent; Recovery; Recruitment Activity; Recycling; Relative (related person); Resistance; Resources; Risk; Savings; Solid; Solutions; Solvents; System; Technology; United States Environmental Protection Agency; Water; Work; base; chemical stability; cost; cost effective; innovation; interest; manufacturing process; molecular sieving; novel; organic acid; polyetheretherketone; polysulphone; polyvinylidene fluoride; programs; public health relevance; success; wasting

DESCRIPTION: Summary Enhanced Recovery of Pharmaceutical Solvent driven by EPA Initiative Recent Events: On July 6, 2011 the United States Environmental Protection Agency (EPA) announced plans to establish new safeguards for hazardous secondary materials recycling with objectives to promote the economic, environmental, and public health benefits of recycling wastes, with an emphasis on several industrial sectors, including the pharmaceutical industry. On average, pharmaceutical manufacturers use at least 100 kg of solvents to make 1 kg of active pharmaceutical ingredient. EPA has determined that the environmental impacts from solvents used as manufacturing and processing aids could be significantly reduced if the product life of solvents used for these purposes were extended to more than a single use. By encouraging the safe recycling of wastes EPA hopes to reduce the life cycle risk of these wastes. Many of the solvents of interest to the EPA under this proposed change to the solid waste definition form mixtures with water that are difficult and/or energy-intensive to separate with conventional separation technologies such as distillation. Energy-efficient, cost effective, and otherwise non-polluting alternative technologies would make solvent recycling more feasible. The net effect of the EPA proposed safeguards is that these will strongly incentify pharmaceutical manufacturers to recycle process solvents. Specific Aim: There are numerous needs in the pharmaceutical industry to use and recover high purity solvents. Key uses include: high purity alcohol, the ability to develop low-cost dewatering of solvents and a relative gentle and simple process for dewatering solvent under mild conditions. Compact Membrane Systems (CMS) proposes a novel membrane process that can lead to extremely high dewatering rates with high separation capabilities based on a family of chemically inert amorphous perfluoro membranes operating under a wide range (almost universal) of operating conditions. CMS's dewatering process is compatible with existing pharmaceutical solvent (PS) processing. Therefore, from a chemical stability standpoint, it can be operated with alcohols, organic acids, ketones, amines and aprotic solvents, to name a few. Since CMS membrane's high flux is based on its high free volume and perfluoro nature, there is little need for concern about chemical interaction with the species present, and the actual permeability does not change significantly with water activity. Therefore, we have a potentially universal and simple system that can work on a wide range of PS for a wide range of applications under varying water activity. To enhance the potential for "universal" PS dehydration, CMS will develop A) membranes with enhanced water/solvent separation and B) more resistant system which equates to more resistant porous supports. CMS has recruited a number of key companies for supplying key materials and subsequently marketing the final product. During Phase I CMS will build a dehydration system and demonstrate dehydration of a number of solvents including methanol. The goal is water/methanol selectivity greater than 15.0. A parallel goal is 50% savings compared to molecular sieves.

描述：概述由EPA倡议推动的药物溶剂的强化回收最近的事件：2011年7月6日，美国环境保护局(EPA)宣布计划为危险二次材料回收建立新的保障措施，目的是促进回收废物的经济、环境和公共健康效益，重点是几个工业部门，包括制药业。平均而言，制药商使用至少100公斤的溶剂来制造1公斤的活性药物成分。环境保护局已经确定，如果用于制造和加工助剂的溶剂的产品寿命延长到不止一次使用，那么用作制造和加工助剂的溶剂对环境的影响可以大大减少。通过鼓励废物的安全回收，环境保护局希望减少这些废物的生命周期风险。根据对固体废物定义的拟议修改，环保局感兴趣的许多溶剂与水形成混合物，用蒸馏等传统分离技术很难分离和/或能源密集型。高能效、高成本效益和其他无污染的替代技术将使溶剂回收更加可行。环保局提议的保障措施的净影响是，这些措施将强烈激励制药制造商回收工艺溶剂。具体目的：制药业有许多使用和回收高纯度溶剂的需求。主要用途包括：高纯度酒精，开发低成本的溶剂脱水的能力，以及在温和条件下相对温和和简单的溶剂脱水工艺。紧凑型膜系统(CMS)提出了一种新颖的膜过程，该膜过程基于一系列化学惰性全氟非晶膜，该膜可以在广泛的(几乎通用的)操作条件下运行，从而获得极高的脱水率和高分离能力。CMS的脱水工艺与现有的药物溶剂(PS)工艺兼容。因此，从化学稳定性的角度来看，它可以与醇、有机酸、酮、胺和非质子溶剂一起操作，仅举几例。由于CMS膜的高通量是基于其高自由体积和全氟性质，因此几乎不需要考虑与存在的物种的化学相互作用，并且实际渗透率不会随着水的活度而显著变化。因此，我们有一个潜在的通用和简单的系统，可以在不同的水活度下对广泛的PS进行广泛的应用。为了增强“通用”PS脱水的可能性，CMS将开发具有增强的水/溶剂分离的A)膜和B)更耐受的系统，这相当于更耐受的多孔支撑体。CMS已经招募了一些关键公司来供应关键材料，并随后销售最终产品。在第一阶段，CMS将建立一个脱水系统，并演示包括甲醇在内的许多溶剂的脱水。目标是水/甲醇的选择性大于15.0。与分子筛相比，另一个类似的目标是节省50%。