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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 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

Article Information

vol. 79 no. 2 125-156
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 
  • Published online May 14, 2025.

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Copyright & Usage 
© PDA, Inc. 2025

Author Information

  1. Josiane Machado Vieira Mattoso1,
  2. Luciana Veloso da Costa1,
  3. Bruna de Almeida do Vale1,
  4. Cristhiane Falavina dos Reis1,
  5. Joyce Modesto de Andrade1,
  6. Lygia Maria Paulo da Silva Braga1,
  7. Greice Maria Silva da Conceição2,
  8. Paulo Borges Mathias Costa1,
  9. Igor Barbosa da Silva1,
  10. Letícia de Alencar Pereira Rodrigues3,
  11. Jeancarlo Pereira dos Anjos3 and
  12. Marcelo Luiz Lima Brandão1,*
  1. 1Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil;
  2. 2Documentation Section, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil; and
  3. 3Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil
  1. ↵* Corresponding Author: Av. Brasil, 4365, Centro Administrativo Vinícius Fonseca, CEP: 21040-900, Manguinhos, Rio de Janeiro-RJ, Brazil; Telephone: +55 2138829364; E-mail: 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
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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