Destin A. LeBlanc,Cleaning Validation Technologies,Technical Consulting ServicesCleaning Memo for MARCH 2004 Another question I commonly get is “What constitutes three consecutive runs for cleaning validation protocol purposes?” The basic approach to answering this question is to use the same principles one uses for process validation. If I am validating a blending process in a certain manufacturing vessel, do the three validation runs have to be one after the other, with no intervening product being processed? Or, in between the three manufacturing processes for the validation, am I allowed to blend other products? Most people would agree that the latter is appropriate for process validation.
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