Regulatory issues design

The equipment used to store blend fuels and inject additives into fuel can be designed to fit a specific application. The equipment selection is based upon several factors including the characteristics of the fuel or additive, operating specifications, and various regulatory issues. 

The Pollution Prevention Act of 1990 propelled these regulatory issues to the forefront of process design by suggesting, the use of materials processes or practices that reduce or eliminate the creation of pollutants or waste at the source. It includes practices that reduce the use of hazardous materials, energy, water or other resources and practices that protect natural resources through conservation or more efficient use (U.S. EPA, 1990b). 

In this chapter, the evolution of the active pharmaceutical ingredient (API) manufacturing process for sunitinib malate will be described. The different routes evaluated to prepare the API, the factors that influenced the choice of the commercial process, salt selection, scale-up experience, and regulatory issues will be discussed in detail. The benefits and challenges of developing a one-pot process will also be highlighted. It is hoped that this chapter will provide a sense of the spectrum of issues to be considered while designing a commercial process. 

The last part of this discussion will be devoted to some overarching issues documentation, the roll of design tools and other resources, and regulatory issues and their impact on the design activity. 

Regulatory issues do have significant impact on the operation of industrial scale processes and must be considered in the early part of process design. These factors are more fully explored in other chapters and will not be discussed in detail here. 

UK Environment Agency letter WEC70020R, Generic Design Assessment - Regulatory Issue RI-AP 1000-0001, Revision 0 , C Grundy, February 1, 2008. 

Kucklick, T. R. 2006. The Medical Device R D Handbook. Boca Raton, FL CRC Press. This one-volume handbook is designed for engineers and is focused on product development of mechanical medical devices, from design and prototyping to managing legal and regulatory issues. 

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