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Research ArticleResearch

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 Machado Vieira Mattoso, Luciana Veloso da Costa, Bruna de Almeida do Vale, Cristhiane Falavina dos Reis, Joyce Modesto de Andrade, Lygia Maria Paulo da Silva Braga, Greice Maria Silva da Conceição, Paulo Borges Mathias Costa, Igor Barbosa da Silva, Letícia de Alencar Pereira Rodrigues, Jeancarlo Pereira dos Anjos and Marcelo Luiz Lima Brandão
PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 125-156; DOI: https://doi.org/10.5731/pdajpst.2023.012883
Josiane Machado Vieira Mattoso
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Luciana Veloso da Costa
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Bruna de Almeida do Vale
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Cristhiane Falavina dos Reis
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Joyce Modesto de Andrade
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Lygia Maria Paulo da Silva Braga
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Greice Maria Silva da Conceição
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Paulo Borges Mathias Costa
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Igor Barbosa da Silva
1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
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Letícia de Alencar Pereira Rodrigues
3Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil
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Jeancarlo Pereira dos Anjos
3Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil
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Marcelo Luiz Lima Brandão
1Laboratory 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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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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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 Machado Vieira Mattoso, Luciana Veloso da Costa, Bruna de Almeida do Vale, Cristhiane Falavina dos Reis, Joyce Modesto de Andrade, Lygia Maria Paulo da Silva Braga, Greice Maria Silva da Conceição, Paulo Borges Mathias Costa, Igor Barbosa da Silva, Letícia de Alencar Pereira Rodrigues, Jeancarlo Pereira dos Anjos, Marcelo Luiz Lima Brandão
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 125-156; 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 Machado Vieira Mattoso, Luciana Veloso da Costa, Bruna de Almeida do Vale, Cristhiane Falavina dos Reis, Joyce Modesto de Andrade, Lygia Maria Paulo da Silva Braga, Greice Maria Silva da Conceição, Paulo Borges Mathias Costa, Igor Barbosa da Silva, Letícia de Alencar Pereira Rodrigues, Jeancarlo Pereira dos Anjos, Marcelo Luiz Lima Brandão
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 125-156; DOI: 10.5731/pdajpst.2023.012883
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    • Abstract
    • 1. Introduction
    • 2. Materials and Methods
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Keywords

  • Pharmaceutical facility
  • Bioburden
  • Quality control
  • Microbial Contamination
  • Contamination Control Strategy
  • Identification

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