Assessing Safety, Health, and Environmental Impact Early during Process Development

During chemical process development, potential safety, health, and environmental (SHE) hazards must be identified, analyzed, and managed as early as possible to avoid negative consequences (higher risks, higher costs, longer development times). The main problem of early SHE assessment is the lack of substance data and process information, especially when batch processes are considered. A new method is presented that closes this gap considerably. SHE aspects are assessed in 11 effect categories. For each substance of a given chemical process and each effect category, the most reliable data are selected out of a variety of different substance databases or estimation methods. After identifying SHE problems as dangerous properties, their magnitude is analyzed as potential of danger and can be reduced by technological measures. In this paper, first the goal and scope of the method is outlined. Then the detailed definitions of all categories as well as the exact way of combining information is presented and discussed with respect to current practices in risk analysis and environmental assessment. Finally the method is applied to a case study from pharmaceutical industry. Major SHE hazards of the process are identified and discussed.