Why is Process Safety Important?
From synthesizing a new API to developing a novel polymer, chemical reactions and the products they form are front and center in the world in which we live. One of the biggest challenges facing those trying to bring these products to market is scale-up: taking small, lab-based synthesis through pilot plant to full-scale manufacture.
It is well-recognized that there are numerous safety risks involved in scaling up chemical processes. Central to these are the changes in heat-loss behavior, which differ with scale:
- Many reactions are exothermic. Due to the small scale, this heat can quickly dissipate to the surrounding environment in a lab-based environment. However, the reaction may require additional active temperature management on scale-up to ensure safe reaction conditions.
- Components in the reaction may become unstable under certain operating conditions, including storing large volumes, which can cause additional hazards that require management.
The risks associated with scale-up have potentially hazardous, even fatal, consequences if not addressed. Thus, thermal and pressure hazards must be considered, identified, assessed, and mitigated at each stage of product development. To achieve these objectives, a number of questions need to be answered, which will depend on the step of the scale-up process (Figure 1). By designing safety into the product development from the earliest stages – a Safety by Design, if you like – one can feel confident that the hazards associated with scale-up to manufacturing can be successfully addressed.