Enhanced Recovery of Pharmaceutical Solvent driven by EPA Initiative

近期事件：2011年7月6日，美国环境保护署（EPA）宣布计划建立新的危险二次材料回收保障措施，目的是促进废物回收的经济、环境和公共健康效益，重点是几个工业部门，包括制药工业。平均而言，制药商至少使用100公斤溶剂来制造1公斤活性药物成分。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，则可以显著减少溶剂对环境的影响。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。根据这一提议的固体废物定义的改变，EPA感兴趣的许多溶剂与水形成混合物，用传统的分离技术（如蒸馏）很难和/或能源密集型分离。节能、低成本和无污染的替代技术将使溶剂回收更加可行。美国环保署提出的保障措施的净效果是，这些措施将强烈激励制药商回收工艺溶剂。具体目的：在制药工业中有许多需要使用和回收高纯度溶剂。主要用途包括：高纯度酒精，开发低成本溶剂脱水的能力，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）提出了一种新的膜工艺，可以导致极高的脱水速率和高分离能力，基于一系列化学惰性无定形全氟膜在广泛（几乎普遍）的操作条件下操作。CMS的脱水工艺与现有的医药溶剂（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、胺和非质子溶剂等操作。由于CMS膜的高通量是基于其高自由体积和全氟性质，因此几乎不需要担心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发生显着变化。因此，我们有了一个潜在的通用和简单的系统，可以在不同水活度下的广泛应用中适用于各种PS。为了提高“通用”PS脱水的潜力，CMS将开发A)具有增强水/溶剂分离的膜，B)更耐药的系统，相当于更耐药的多孔支撑。CMS已经招募了一些重要的公司来提供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多种溶剂的脱水。目标是水/甲醇选择性大于15.0。与分子筛相比，一个平行的目标是节省50%。

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.