(540c) Sustainable Drug Manufacturing Planning under Different Regulatory Scenarios

Abstract

Current environmental regulations typically follow a command-and-control type of approach prescribing the use of state-of-the-art abatement technology to limit site emissions of pollutants. However, this type of regulation does not sufficiently encourage process improvement by research and development of new technologies for reducing emissions beyond the desired compliance. It has been shown that the marked-based regulatory models are able to create economic incentives for continuous improvement of cleaner manufacturing practices. Two problems still not solved in a systematic fashion, are how plant managers should optimally plan under different regulatory scenarios and how regulators should optimally design the regulations. In order to assess the impact of different regulations, this paper proposes a holistic model for batch drug manufacturing operations including standard recycle and treatment options available to the pharmaceutical industry. Our work considers the technological limitations of the pollution prevention equipments by deploying accurate chemical engineering models (e.g. shortcut method for distillation columns, solubility models in scrubbers), to estimate the technical feasibility of a treatment, its cost and emissions. This approach will offer plant managers a systematic tool to ascertain expected effective and compliance cost of new environmental regulations consistent with technological and financial limitations. Alternately we conjecture that new regulations could be designed using the concepts in this paper to achieve desirable emission reduction with lowest cost to the industry.