Enhanced Recovery of Pharmaceutical Solvent driven by EPA Initiative

Summary Enhanced Recovery of Pharmaceutical Solvent driven by EPA InitiativeThe United States Environmental Protection AgencyEPAis establishing new safeguards for hazardous secondary materials with objectives to promote the economicenvironmentaland public health benefits of recycling wasteswith an emphasis on several industrial sectorsincluding the pharmaceutical industryOn averagepharmaceutical manufacturers use at leastkg of solvents to makekg of active pharmaceutical ingredientEPA 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 useBy encouraging the safe recycling of wastes EPA hopes to reduce the life cycle risk of these wastesMany of the solvents of interest to the EPA form mixtures with water that are difficult and or energyintensive to separate with conventional separation technologies such as distillationEnergy efficientcost effectiveand otherwise non polluting alternative technologies would make solvent recycling more feasibleThe net effect of the EPA proposed safeguards is that these will strongly incentify pharmaceutical manufacturers to recycle process solventsThere are numerous needs in the pharmaceutical industry to use and recover high purity solventsKey uses includehigh purity alcoholthe ability to develop low cost dewatering of solvents and a relative gentle and simple process for dewatering solvent under mild conditionsCompact Membrane SystemsCMSproposes 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 rangealmost universalof operating conditionsCMS s dewatering process is compatible with existing pharmaceutical solventPSprocessingThereforefrom a chemical stability standpointit can be operated with alcoholsorganic acidsketonesamines and aprotic solventsto name a fewSince CMS membrane s high flux is based on its high free volume and perfluoro naturethere is little need for concern about chemical interaction with the species presentand the actual permeability does not change significantly with water activityThereforewe 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 activityTo enhance the potential foruniversalPS dehydrationCMS will develop Amembranes with enhanced water solvent separation and Bmore resistant system which equates to more resistant porous supportsCMS has recruited a number of key companies for supplying key materials and subsequently marketing the final productCMS has acquired the resourcespeople and facilitiesto prepare perfluoro copolymers which are not available elsewhere and which possess a new range of propertiesAlthough the familiar monomer tetrafluoroethyleneTFEis too hazardous for handling by a small companya variety of other fluorinated monomers are safe to handleMany copolymers have now been prepared by CMSBy not using TFE in our synthesiswe eliminate potential explosions and contact with potential carcinogensAlso we do not use PFOA Csurfactants as an additional precautionDuring Phase II CMS will build a dehydration system and demonstrate dehydration of a number of solvents including methanolGiven our innovative success in Phase I with porous supports and special perfluoropolymer membranesthese materials will be used whenever existing porous supports and membranes do not work wellWhile we have been very successful with special perfluoropolymer membranes for enhanced solvent dehydrationthis work has been exclusively using small laboratory scale membranesPhase II will focus on scaling up the membrane size and demonstrating it on real systemsi eworking with pharmaceutical companies and the EPAProject Narrative Enhanced Recovery of Pharmaceutical Solvent Driven by EPA Initiative CMS will develop custom membranes with enhanced separation and highly resistant porous supports to permit energy efficientcost effectiveand otherwise non polluting alternative technologies for pharmaceutical solvent conservationrecyclingOn averagepharmaceutical manufacturers use at leastkilograms of solvents to makekilogram of active pharmaceutical ingredientWhile we have been very successful with special perfluoropolymer membranes for enhanced solvent dehydrationthis work has been using small laboratoryscale membranesThe Phase II SBIR program will focus on scaling up the membrane size and demonstrating it on commercially feasible systemswhile working with pharmaceutical companies and the EPA