Defining Three “Consecutive” Runs

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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