Robustness

Robustness, like ruggedness, is the demonstration of the ability of the chosen method to cope with variations. However, for robustness the critical test parameters are deliberately varied. For example, the concentration of any reagents used may be varied by ± 20%; the incubation temperatures could be used at the top or bottom of the acceptable range; mixing or holding times can be varied, and so on. The objective is to demonstrate across a range of microorganisms and dilutions, that such deliberate variations do not impact on the method's ability to accurately determine the number of microorganisms present.

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