Universal Membrane Dehydrator for Dewatering Pharmaceutical Solvents

Compact Membrane Systems, Inc., Newport DE

Investigators

Abstract

Project Summary Specific Aim: There are numerous needs in the pharmaceutical industry to use and recover high purity solvents. Key uses include: high purity alcohol for various applications, the ability to develop low-cost dewatering of solvents and a relatively 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 totally perfluoropolymer (PFP) membrane system 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. To enhance the potential for ?universal? PS dehydration, CMS will totally remove the porous support and also use PFP potting. Product Concept: To develop a universal membrane dehydrator (UMD) the whole system needs to be PFP based. Right now, while the CMS membrane is PFP based, the membrane sits on a hydrocarbon porous support and uses a hydrocarbon (HC) epoxy potting system. Using proprietary processing technology in combination with our expertise in the synthesis and know how in PFP, we will fabricate UMD that eliminate hydrocarbon based components from the final product. This will be done by (1) minimizing hydrocarbon-based components, and (2) removing hydrocarbon-based components that are used in processing. Recent Events: EPA has established new safeguards for hazardous secondary materials recycling. The objectives of these new safeguards are 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 manufacturer 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. See letter of support from EPA. Existing Separation Technologies: The commercial standard dehydration procedure is molecular sieve drying. Polyvinyl alcohol (PVA) membranes have historically been the standard membrane dehydrator. Our results show the CMS membranes are simpler, better and dramatically more stable than PVA membranes. Program Objectives / Milestones: The key program objective / milestone will be achieving a 90% reduction in contaminants being in the extracted solutions.