Microbiological monitoring of clean rooms in development of vaccines

Detalhes bibliográficos
Autor(a) principal: Utescher,Carla Lílian de Agostini
Data de Publicação: 2007
Outros Autores: Franzolin,Marcia Regina, Trabulsi,Luiz Rachid, Gambale,Valderez
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Journal of Microbiology
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822007000400023
Resumo: The aim of the present work was to evaluate an environmental monitoring program for clean rooms, or classified environments, involved in the filling and quality control of biological products produced by Butantan Institute, São Paulo, Brazil. This monitoring established the quantification, characterization and seasonality of the microorganisms in air and operators and, moreover, determined the alert and action limits. The total detectable microbial number showed some contrasts in installed air purification systems and in the operational impact on adopted procedures. The typical microbial population consisted of Staphylococcus sp, Micrococcus sp, Bacillus sp and Penicillium sp. The highest microorganism concentration occurred during summer and springtime. The established internal alert and action limits supported the operational procedures. Therefore, the environmental monitoring program is recommended for other laboratories involved in the production of vaccines, hyperimmune sera and biopharmaceuticals.
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spelling Microbiological monitoring of clean rooms in development of vaccinesenvironmental controlviable particlesclean roomsalert and action limitsThe aim of the present work was to evaluate an environmental monitoring program for clean rooms, or classified environments, involved in the filling and quality control of biological products produced by Butantan Institute, São Paulo, Brazil. This monitoring established the quantification, characterization and seasonality of the microorganisms in air and operators and, moreover, determined the alert and action limits. The total detectable microbial number showed some contrasts in installed air purification systems and in the operational impact on adopted procedures. The typical microbial population consisted of Staphylococcus sp, Micrococcus sp, Bacillus sp and Penicillium sp. The highest microorganism concentration occurred during summer and springtime. The established internal alert and action limits supported the operational procedures. Therefore, the environmental monitoring program is recommended for other laboratories involved in the production of vaccines, hyperimmune sera and biopharmaceuticals.Sociedade Brasileira de Microbiologia2007-12-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822007000400023Brazilian Journal of Microbiology v.38 n.4 2007reponame:Brazilian Journal of Microbiologyinstname:Sociedade Brasileira de Microbiologia (SBM)instacron:SBM10.1590/S1517-83822007000400023info:eu-repo/semantics/openAccessUtescher,Carla Lílian de AgostiniFranzolin,Marcia ReginaTrabulsi,Luiz RachidGambale,Valderezeng2008-01-28T00:00:00Zoai:scielo:S1517-83822007000400023Revistahttps://www.scielo.br/j/bjm/ONGhttps://old.scielo.br/oai/scielo-oai.phpbjm@sbmicrobiologia.org.br||mbmartin@usp.br1678-44051517-8382opendoar:2008-01-28T00:00Brazilian Journal of Microbiology - Sociedade Brasileira de Microbiologia (SBM)false
dc.title.none.fl_str_mv Microbiological monitoring of clean rooms in development of vaccines
title Microbiological monitoring of clean rooms in development of vaccines
spellingShingle Microbiological monitoring of clean rooms in development of vaccines
Utescher,Carla Lílian de Agostini
environmental control
viable particles
clean rooms
alert and action limits
title_short Microbiological monitoring of clean rooms in development of vaccines
title_full Microbiological monitoring of clean rooms in development of vaccines
title_fullStr Microbiological monitoring of clean rooms in development of vaccines
title_full_unstemmed Microbiological monitoring of clean rooms in development of vaccines
title_sort Microbiological monitoring of clean rooms in development of vaccines
author Utescher,Carla Lílian de Agostini
author_facet Utescher,Carla Lílian de Agostini
Franzolin,Marcia Regina
Trabulsi,Luiz Rachid
Gambale,Valderez
author_role author
author2 Franzolin,Marcia Regina
Trabulsi,Luiz Rachid
Gambale,Valderez
author2_role author
author
author
dc.contributor.author.fl_str_mv Utescher,Carla Lílian de Agostini
Franzolin,Marcia Regina
Trabulsi,Luiz Rachid
Gambale,Valderez
dc.subject.por.fl_str_mv environmental control
viable particles
clean rooms
alert and action limits
topic environmental control
viable particles
clean rooms
alert and action limits
description The aim of the present work was to evaluate an environmental monitoring program for clean rooms, or classified environments, involved in the filling and quality control of biological products produced by Butantan Institute, São Paulo, Brazil. This monitoring established the quantification, characterization and seasonality of the microorganisms in air and operators and, moreover, determined the alert and action limits. The total detectable microbial number showed some contrasts in installed air purification systems and in the operational impact on adopted procedures. The typical microbial population consisted of Staphylococcus sp, Micrococcus sp, Bacillus sp and Penicillium sp. The highest microorganism concentration occurred during summer and springtime. The established internal alert and action limits supported the operational procedures. Therefore, the environmental monitoring program is recommended for other laboratories involved in the production of vaccines, hyperimmune sera and biopharmaceuticals.
publishDate 2007
dc.date.none.fl_str_mv 2007-12-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822007000400023
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822007000400023
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S1517-83822007000400023
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Sociedade Brasileira de Microbiologia
publisher.none.fl_str_mv Sociedade Brasileira de Microbiologia
dc.source.none.fl_str_mv Brazilian Journal of Microbiology v.38 n.4 2007
reponame:Brazilian Journal of Microbiology
instname:Sociedade Brasileira de Microbiologia (SBM)
instacron:SBM
instname_str Sociedade Brasileira de Microbiologia (SBM)
instacron_str SBM
institution SBM
reponame_str Brazilian Journal of Microbiology
collection Brazilian Journal of Microbiology
repository.name.fl_str_mv Brazilian Journal of Microbiology - Sociedade Brasileira de Microbiologia (SBM)
repository.mail.fl_str_mv bjm@sbmicrobiologia.org.br||mbmartin@usp.br
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