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.

Public Health Relevance

Enhanced Recovery of Pharmaceutical Solvent Driven by EPA Initiative CMS will develop membranes with enhanced separation and highly resistant porous supports to permit energy- efficient, cost effective, and otherwise non-polluting alternative technologies for solvent recycling.

National Institute of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-IMST-M (13))
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Shaughnessy, Daniel
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Compact Membrane Systems, Inc.
United States
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