The process development cycle

Fig. 7.2 illustrates for the pharmaceutical industry 1) the major milestones or events in the process development cycle and (2) a typical sequence of events. The process... 

Another important aspect of detection in the process development cycle is the identification of a wavelength(s) and a cell path length that allows one to monitor the process response. The best way to address this issue is experimentally. The final testing and determination of the cell path length that gives an on-scale response will likely have to be done on the production floor. 

The primary considerations which need to be addressed during or after the process development cycle with respect to environmental issues are (1) disposal of spent packing, (2) solvent disposal, (3) solvent recovery. (4) obtaining the air permits for the solvent systems in use, (5) systems in place to meet OSHA and EPA guidelines, and (6) the DOT classification. Environment guidelines and regulations are not within the scope of this chapter. 

This text covers those three activities of development, manufacturing, and regulation in its broadest sense. This will include discussions on the process development cycle, introduction of the process into factory design engineering, regulatory matters that include the regulatory approval pro-... 

Typically, process development for an API takes about 9 to 12 months from route identification to commercial-level scale-up. The process development cycle is shown in Fig. 23.1. In the figure, the solid lines represent the normal flow of a process from laboratory scale (10 to 1(X) g) to kilo-lab scale (500 g to 2 kg) to pilot-plant scale (5 to 50 kg) to full... 

There are already many examples of advances ofPSE embedding sustainabihty aspects as part of the process development cycle. Continuous microreactors from Coming utilized for fine chemicals and pharmaceuticals [97], continuous formulation processes, process intensification demonstrated in several processes [98], and life cycle assessment evaluations integrated into process development [99], to mention a few. However, a more widespread uptake is needed, so they are used routinely. 

Exxon Chemical (French et al., 1996 Wixom, 1995) has developed an inherent safety review process, and its application at various points in the process life cycle. 

Understanding the critical processes in the development of a master production record will help prevent problems during production activities. It is imperative to document the entire development cycle of the product for future reference. Based upon this premise, the following information should be utilized as a guideline for development of the master production record. 

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