Expert systems commercial factors

A number of software packages or expert systems for ruggedness testing has been developed. RES (commercialized under the name Shaiker ) is an expert system created by Van Leeuwen et al. [4,23] and has been validated and evaluated [42,43]. It uses fractional factorial and Plackett-Burman designs and allows to test the factors at two or three levels. The interpretation criteria used here are the predefined values (see Section 3.4.8). 

To develop a product from inception to market, the product and process have to be optimised and the process scaled up and transferred to commercial production. Definitions and descriptions of the requirements for all these stages of development are discussed in Chapter 8, although the major discussion is on the preformulation/formulation input to product optimisation. The many factors which a formulator should consider in the selection of pharmaceutical excipients and packaging are discussed. Useful sources of information and techniques for selection such as expert systems and experimental design tools are included. 

In most commercial process simulators, model parameters for pure component properties and binary parameters can be found for a large number of compounds and binary systems. However, the simulator providers repeatedly warn in their software documentations and user manuals that these default parameters should be applied only after careful examination by the company s thermodynamic experts prior to process simulation. For verification of the model parameters again, a large factual data bank like the DDE is the ideal tool. The DDE allows checking all the parameters used for the description of the pure component properties as a function of temperature and of the binary parameters of a multicomponent system by access to the experimental data stored. On the basis of the results for the different pure component properties and phase equilibria, excess enthalpies, activity coefficients at infinite dilution, separation factors, and so on, the experienced chemical engineer can decide whether all the data and parameters are sufficiently reliable for process simulation. 

Consequently, prevention and error management programs based on system safety and human factors concepts not only improve safety within the workforce, but are also commercially attractive. As Professor Patrick Hudson, a leading world expert in system safety and human factors has argued, a company safety department or system should be seen as a profit centre, not as a cost centre (Hudson, 1998). 

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