Sustainable reduction of bioreactor contamination in an industrial fermentation pilot plant.
J Biosci Bioeng
; 102(4): 251-68, 2006 Oct.
Article
em En
| MEDLINE
| ID: mdl-17116571
ABSTRACT
Facility experience primarily in drug-oriented fermentation equipment (producing small molecules such as secondary metabolites, bioconversions, and enzymes) and, to a lesser extent, in biologics-oriented fermentation equipment (producing large molecules such as recombinant proteins and microbial vaccines) in an industrial fermentation pilot plant over the past 15 years is described. Potential approaches for equipment design and maintenance, operational procedures, validation/verification testing, medium selection, culture purity/sterility analysis, and contamination investigation are presented, and those approaches implemented are identified. Failure data collected for pilot plant operation for nearly 15 years are presented and best practices for documentation and tracking are outlined. This analysis does not exhaustively discuss available design, operational and procedural options; rather it selectively presents what has been determined to be beneficial in an industrial pilot plant setting. Literature references have been incorporated to provide background and context where appropriate.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Microbiologia Industrial
/
Descontaminação
/
Contaminação de Equipamentos
/
Análise de Falha de Equipamento
/
Reatores Biológicos
/
Fermentação
/
Manutenção
Tipo de estudo:
Guideline
Idioma:
En
Revista:
J Biosci Bioeng
Assunto da revista:
ENGENHARIA BIOMEDICA
/
MICROBIOLOGIA
Ano de publicação:
2006
Tipo de documento:
Article
País de afiliação:
Estados Unidos