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Technical evaluation of the potential for streamlining of equipment validation for fermentation applications
Author(s) -
Junker Beth
Publication year - 2001
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.1094
Subject(s) - scope (computer science) , autoclave , quality (philosophy) , computer science , process (computing) , reliability engineering , risk analysis (engineering) , process engineering , biochemical engineering , environmental science , systems engineering , engineering , business , philosophy , epistemology , chemical engineering , programming language , operating system
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. © 2001 John Wiley & Sons, Inc. Biotechnol Bioeng 74: 49–61, 2001.