Abstract:
: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.
journal_name
Biotechnol Bioengjournal_title
Biotechnology and bioengineeringauthors
Junker Bdoi
10.1002/bit.1094subject
Has Abstractpub_date
2001-07-05 00:00:00pages
49-61issue
1eissn
0006-3592issn
1097-0290pii
10.1002/bit.1094journal_volume
74pub_type
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