Live eLearning - PDA 706 Cleaning and Disinfection - What a Phase III Disinfection Trial Should Include
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Following laboratory disinfectant testing, the next step to test the effectiveness of a cleaning and disinfection regime is to collect the monitoring data from the manufacturing area, or Phase III ‘in-situ’ studies. Evaluation of in-situ data will verify that the regime can establish and maintain a level of control that minimizes the potential risk of contamination in the manufacturing process from the environment. This presentation will consider what elements to include and how to conduct a Phase III trial.
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