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 potential to acceptably reduce the scope of validation and qualification testing based on scientific justification for the specific area of microbial fermentation. The key areas explored include: autoclave operational qualification (OQ) testing, autoclave load pattern testing, vessel sterilize-in-place 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 procedures involved. Methodologies are described for how to evaluate the systems being 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 groups within the organization for the specific process and equipment in use.
Junker
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Bioprocess R&D, Merck Research Laboratories, RY810-126, P.O. Box 2000, Rahway, New Jersey 07065, USA. beth_junker@merck.com
D005069:Evaluation Studies as Topic; D005285:Fermentation; D005544:Forecasting; D008828:Microbiological Techniques / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D013696:Temperature