Microbiology-PTM-OMA_Modules_1-5

Examples of Robustness Parameters • REAGENTS • SAMPLE

• temperature of reagent at time of  analysis • concentrations of reagents at  specified limits • source of reagents • age of reagents • quantity of reagents • mixing times • reaction times • temperature of analysis • flow rates • variance in measuring apparatus

• temperature of sample at time  of analysis • accuracy of obtaining sample  quantity • age of sample prior to analysis • extraction time • Test portion enrichment time or  temperature