Factors in equipment scale-up and design

Change in batch size, up to and including a factor of ten times the size of the pivotal clinical trial/biobatch, where (1) the equipment used to produce the test batch(es) are of the same design and operating principles (2) the batch(es) is manufactured in full compliance with cGMPs and (3) the same standard operating procedures (SOPs) and controls, as well as the same formulation and manufacturing procedures, are used on the test batch(es) and on the full-scale production batch(es). 

The same factor is used for the scale-up of the sample load. The translation of an analytical method to a preparative system is obviously dependent on the sorbent characteristics of the preparative column. Several reviews on preparative methods, column-packing techniques, theory, and equipment design have been published [132-135,145]. Specific examples of the application of preparative procedures are listed in Table 5.3. 

An item of concern to all, in evaluating an experiment, or in scaling up for pilot plant operation, is the electrical efficiency of a process. Care must be taken not to confuse equipment power factor with what might be called electrical efficiency of conversion, though both may contribute to the same end result. Power factor relates to ability to convert equipment input volt-amperes (not necessarily in phase) to available chemical-result-producing watts. This is a function of electrical equipment and electrical circuit design. 

For preliminary evaluation (Gate 1 in Table 16.1), correlations for complete processes scaled up for capacity and for time are commonly used. For a conceptual design (Gate 2), FOB equipment cost correlations based on flow rate are often used and scaled up to BM cost based on L -f M factors. For a preliminary engineering design (Gate 3), the equipment is sized more accurately based on simple rules of thumb, the cost is estimated from FOB cost correlations related to equipment size and scaled up to BM cost based on L + M factors. The process and FOB cost correlations are all of the form... 

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