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

The purpose of this article is to provide a few concrete examples of the po tential to acceptably reduce the scope of validation and qualification test ing based on scientific justification for the specific area of microbial fe rmentation. The key areas explored include: autoclave operational qualifica tion (OQ) testing, autoclave load pattern testing, vessel sterilize-in-plac e testing, spore strip use and failure investigation, grouping of D-values for media and concentrated nutrients, influence of temperature on D-values, and equipment clean-in-place cleaning agent/recovery studies. Suggestions are offered based on technical data and engineering analysis of the procedu res involved. Methodologies are described for how to evaluate the systems b eing tested relative to processing requirements to determine which testing might be minimized and which testing might warrant expansion. The ultimate risk to quality then must be evaluated by the designated quality control gr oups within the organization for the specific process and equipment in use. (C) 2001 John Wiley & Sons, Inc. Biotechnol Bioeng 74: 49-61, 2001.