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EHS Considerations in the Development of RaloxifeneThe initial raloxifene manufacturing route identified during the development process had many environmental drawbacks. The manufacturing process produced significant amounts of aluminum waste, used large amounts of various solvents, and used compounds with high odor potential. Environmental representatives working with the development team challenged the team to reconsider the route of manufacture due to the solvents selected and potential waste handling issues. The resulting success story proved that incorporating environmental considerations early in the development cycle can have both pollution prevention and economic impacts.
Environmental BenefitsThe process development group's goal was to identify manufacturing processes with less environmental impact. Their efforts resulted in a new manufacturing process that generated a higher quality product and reduced or eliminated many other negative environmental and safety factors associated with the initial production route. Lilly eliminated the aluminum solid waste stream, eliminated the use of odiferous raw materials, eliminated the use of methylene chloride, reduced the number of high pressure and temperature reactions, and eliminated all distillation steps from the processes. The amount of solvent used in the manufacturing process was reduced from 250 liters per kilogram of final product to around 98 liters per kilogram of final product, representing a reduction of over 60%. The amount of waste produced per unit of final product was reduced by about 80%.
Health and Safety ImprovementsAlthough Lilly's primary goal was to reduce the environmental impact of the manufacturing process for raloxifene, the company also realized significant health and safety benefits. The potential for accidents and employee exposure was reduced considerably since the manufacturing process selected is less hazardous and generates less waste. The efficiency improvements will make production of the product safer for employees and neighbors.
Economic BenefitsLilly also realized direct economic benefits from modifying the raloxifene manufacturing processes relative to the costs of raw materials and waste treatment. Per unit of product, the new manufacturing route has reduced the cost of solvents by nearly 75%. Since the process produces less waste, waste treatment costs have been reduced significantly. The reduction in waste from the process also has a direct impact on the capacity of Lilly's waste treatment facilities. Reduction in waste allows the current capacity to be utilized as efficiently as possible and lessens the need to build new treatment facilities.
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