Выражение встречается в следующем контексте:
During development, control parameters are optimized for each unit operation. During the preparation of the validation batches (i.e., three to five consistency batches at pilot or full scale, generally during phase III pivotal clinical trials), the control parameters are tested by determining the outputs under worst-case conditions. With biotechnology processes, the variables clearly impact one another. For example, a change in pH may impact the required conductivity range that enables production of the desired product. Multifactorial analysis is often used to minimize the number of runs that must be performed during validation of modern biotechnology processes [17]. There are many approaches to process validation and there are some who advocate testing all parameters to the edge of failure. This approach can be very costly. Others in the biotechnology industry advocate only testing to the edge of failure those parameters likely to cause variability. For example, temperature can be rigorously controlled within a very narrow range. In designing validation studies, it is cost-effective to maintain this control and avoid pushing the process to fail at temperatures outside the specified range.
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