Technical evaluation of the potential for streamlining of equipment validation for fermentation applications.

摘要: The purpose of this article is to provide a few concrete examples the potential acceptably reduce scope validation and qualification testing based on scientific justification for specific area microbial fermentation. key areas explored include: autoclave operational (OQ) testing, load pattern vessel sterilize-in-place spore strip use failure investigation, grouping D-values media concentrated nutrients, influence temperature D-values, equipment clean-in-place cleaning agent/recovery studies. Suggestions are offered technical data engineering analysis procedures involved. Methodologies described how evaluate systems being tested relative processing requirements determine which might be minimized warrant expansion. ultimate risk quality then must evaluated by designated control groups within organization process in use.