B. Junker, Technical evaluation of the potential for streamlining of equipment validation for fermentation applications, BIOTECH BIO, 74(1), 2001, pp. 49-61
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.