Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results

Josiane M.V. Mattoso; Luciana V. Costa; Bruna A. Vale; Cristhiane M.F. Reis; Joyce M. Andrade; Lygia Maria P.S. Braga; Greice Maria S. Conceição; Paulo B.M. Costa; Igor B. Silva; Letícia A.P. Rodrigues; Jeancarlo P. Anjos; Marcelo Luiz Lima Brandão

doi:10.5731/pdajpst.2023.012883

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Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results

Josiane M.V. Mattoso, Luciana V. Costa, Bruna A. Vale, Cristhiane M.F. Reis, Joyce M. Andrade, Lygia Maria P.S. Braga, Greice Maria S. Conceição, Paulo B.M. Costa, Igor B. Silva, Letícia A.P. Rodrigues, Jeancarlo P. Anjos and Marcelo Luiz Lima Brandão

PDA Journal of Pharmaceutical Science and Technology June 2024, pdajpst.2023.012883; DOI: https://doi.org/10.5731/pdajpst.2023.012883

Josiane M.V. Mattoso

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: josiane@bio.fiocruz.br

Luciana V. Costa

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: luciana.costa@bio.fiocruz.br

Bruna A. Vale

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: bruna.vale@bio.fiocruz.br

Cristhiane M.F. Reis

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: cristhiane.moura@bio.fiocruz.br

Joyce M. Andrade

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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Lygia Maria P.S. Braga

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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Greice Maria S. Conceição

2 Documentation Section, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: greice.conceicao@bio.fiocruz.br

Paulo B.M. Costa

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: paulo.borges@bio.fiocruz.br

Igor B. Silva

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: igor.barbosa@bio.fiocruz.br

Letícia A.P. Rodrigues

3 Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil

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For correspondence: leticiap@fieb.org.br

Jeancarlo P. Anjos

3 Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil

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Marcelo Luiz Lima Brandão

1 Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;

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For correspondence: marcelo.brandao@bio.fiocruz.br

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Article Information

pdajpst.2023.012883

DOI

https://doi.org/10.5731/pdajpst.2023.012883

PubMed

38942484

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received July 26, 2023
Accepted June 11, 2024
Published online June 28, 2024.

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Author Information

Josiane M.V. Mattoso1 (josiane{at}bio.fiocruz.br),
Luciana V. Costa1 (luciana.costa{at}bio.fiocruz.br),
Bruna A. Vale1 (bruna.vale{at}bio.fiocruz.br),
Cristhiane M.F. Reis1 (cristhiane.moura{at}bio.fiocruz.br),
Joyce M. Andrade1 (joyce{at}bio.fiocruz.br),
Lygia Maria P.S. Braga1 (lygia.braga{at}bio.fiocruz.br),
Greice Maria S. Conceição2 (greice.conceicao{at}bio.fiocruz.br),
Paulo B.M. Costa1 (paulo.borges{at}bio.fiocruz.br),
Igor B. Silva1 (igor.barbosa{at}bio.fiocruz.br),
Letícia A.P. Rodrigues3 (leticiap{at}fieb.org.br),
Jeancarlo P. Anjos3 (jeancarlo.anjos{at}fieb.org.br) and
Marcelo Luiz Lima Brandão1,4 (marcelo.brandao{at}bio.fiocruz.br)

¹ Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
² Documentation Section, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
³ Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil

↵* Corresponding author; email: marcelo.brandao{at}bio.fiocruz.br

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Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results

PDA Journal of Pharmaceutical Science and Technology Jun 2024, pdajpst.2023.012883; DOI: 10.5731/pdajpst.2023.012883

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Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results

PDA Journal of Pharmaceutical Science and Technology Jun 2024, pdajpst.2023.012883; DOI: 10.5731/pdajpst.2023.012883

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Keywords

Pharmaceutical facility
Bioburden
Contamination Control Strategy
Identification
Microbial Contamination
Quality control

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Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results

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