Caracterização de bactérias isoladas de ambientes de produção farmacêutica e depósito na coleção de bactérias do ambiente e saúde (FIOCRUZ/CBAS)
Palavras-chave:
Controle microbiológico, Identificação bacteriana, Coleções microbiológicas, 16S rRNA, Indústria farmacêutica
Resumo
Introdução: A presença de microrganismos em ambientes farmacêuticos representa um desafio crítico para o controle microbiológico, podendo impactar a qualidade e a segurança dos produtos. Objetivo: Caracterizar bactérias isoladas de ambientes farmacêuticos e depositadas na Coleção de Bactérias do Ambiente e Saúde (CBAS) da Fundação Oswaldo Cruz. Método: Foram depositadas 410 cepas isoladas de diferentes tipos de amostras de duas instalações de produção farmacêutica, provenientes principalmente de soluções intermediárias de processo (n=93), biocarga (n=41), produtos intermediários (n=35), água purificada (n=33) e água potável (n=28), entre outras. Destas, 331 foram identificadas por meio do sequenciamento do gene 16S rRNA. Resultados: Foram identificados 33 gêneros bacterianos, destacando-se Staphylococcus (n=118; 35,6%), Bacillus (n=67; 20,2%), Pseudomonas (n=41; 12,4%) e Burkholderia (n=34; 10,3%). O índice de diversidade de Simpson foi de 0,806. A comparação entre as identificações realizadas pelo depositante e pela CBAS demonstrou consistência metodológica. Conclusões: A CBAS constitui um recurso relevante para a preservação de linhagens bacterianas provenientes da indústria farmacêutica, apoiando aplicações industriais e futuras pesquisas científicas.Referências
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CHURCH, D. L. et al. Performance and Application of 16S rRNA Gene Cycle Sequencing for Routine Identification of Bacteria in the Clinical Microbiology Laboratory. Clin Microbiol Rev., v. 33, n. 4, p. e00053-19, 2020.
COSTA, L. V. et al. Assessment of VITEK®2, MALDI-TOF MS and full gene 16S rRNA sequencing for aerobic endospore-forming bacteria isolated from a pharmaceutical facility. J. Microbiol. Meth., v. 194, p. 106419, 2022.
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MATTOSO, J. M. V. et al. 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 J. Pharm. Sci. Technol., v. 79, n. 2, p. 125-156, 2025.
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RAMOS, J. N.; et al. Genome-based taxonomic characterization of Lederbergia fracalanzzae sp. nov., a novel species isolated from a pharmaceutical industry facility and expansion of the MALDI-TOF/MS database. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 10., 2026. Rio de Janeiro. Annals [...]. Rio de Janeiro: Bio-Manguinhos, 2026. p. 229.
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RHODES, Vinicius Pessanha et al. Evaluation of microorganisms recovery capacity in different surfaces using Quantiswab aiming to implement in environmental monitoring of Pharmaceutical industries facilities. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 10., 2026. Rio de Janeiro. Annals [...]. Rio de Janeiro: Bio-Manguinhos, 2026. p. 216.
SHERABA, N. S.; YASSIN, A. S.; AMIN, M. A. High-throughput molecular identification of Staphylococcus spp. isolated from a clean room facility in an environmental monitoring program. BMC Res. Notes, v. 3, n. 1, p. 278, 2010.
SILVA-SANTANA, G. et al. Pharmaceutical contamination by biofilms formed of the Burkholderia cepacia complex: public health risks. Processes, v. 13, p. 1270, 2025.
SOARES, G.; AMORIM-NETO, D. P.; COGO-MÜLLER, K. Culturable microbiological profile of a non-sterile drugs pharmaceutical production environment. Braz. J. Pharm. Sci., v. 60, p. e23664, 2024.
SONG, M. et al. A comprehensive technology strategy for microbiological identification in a pharmaceutical facility: a case study. Front. Microbiol., v. 15, p. 1327175, 2024.
SUTTON, S. The environmental monitoring program in a GMP environment. Journal of GXP Compliance, v. 14, n. 3, p. 22–30, 2010.
SUTTON, S. Microbiology and environmental monitoring in aseptic processing. American Pharmaceutical Review, v. 15, n. 5, p. 18–25, 2012.
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VALADÃO, T. B. et al. Evaluation of the Nutritive Capacity of Soybean Tryptic Agar for Environmental Control in the Pharmaceutical Industry. Revista Cubana de Farmacia, v. 56, n. 4, p. e1012, 2023
VASCONCELLOS, L. et al. Phenotypical and molecular characterization of Acinetobacter spp. isolated from a pharmaceutical facility. Lett. Appl. Microbiol., v. 77, n. 5, p. ovad101, 2023.
VASCONCELLOS, L. et al. Phenotypical and molecular characterization of Pseudomonas spp. isolated from a pharmaceutical facility. Processes, v. 14, n. 2, p. 231, 2026.
WORLD FEDERATION FOR CULTURE COLLECTIONS (WFCC). Guidelines for the establishment and operation of collections of microorganisms. Utrecht: World Federation for Culture Collections, 2010.
ANDRADE, J. M. et al. Validation of MALDI-TOF MS database expansion with spectra of in house bacterial strains isolated in the pharmaceutical industry. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 9., 2025. Rio de Janeiro. Annals... Rio de Janeiro: Bio-Manguinhos, 2025. p. 59.
AREZ, A. P. et al. Biobanking for tropical health: leveraging collaborative initiatives in the Lusophone world. Front. Trop. Dis, v. 5, p. 1438842, 2024.
BRASIL. Agência Nacional de Vigilância Sanitária. Resolução RDC nº 658, de 30 de março de 2022. Dispõe sobre as Diretrizes Gerais de Boas Práticas de Fabricação de Medicamentos. Diário Oficial da União, Brasília, DF: ANVISA, 2022.
CALDEIRA, N. G. S. et al. Characterization by MALDI-TOF MS and 16S rRNA gene sequencing of aerobic endospore-forming bacteria isolated from pharmaceutical facility in Rio de Janeiro, Brazil. Microorganisms, v. 12, n. 4, p. 724, 2024.
CALDEIRA, N. G. S. et al. Description of Brachybacterium manguinensis sp. nov.: a new species isolated from an immunobiological pharmaceutical facility in Rio de Janeiro, Brazil. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 10., 2026. Rio de Janeiro. Annals [...]. Rio de Janeiro: Bio-Manguinhos, 2026. p. 205.
CHALITA, M., et al. EzBioCloud: a genome-driven database and platform for microbiome identification and discovery. Int J Syst Evol Microbiol., v. 74, n. 6, p. 006421, 2024.
CHURCH, D. L. et al. Performance and Application of 16S rRNA Gene Cycle Sequencing for Routine Identification of Bacteria in the Clinical Microbiology Laboratory. Clin Microbiol Rev., v. 33, n. 4, p. e00053-19, 2020.
COSTA, L. V. et al. Assessment of VITEK®2, MALDI-TOF MS and full gene 16S rRNA sequencing for aerobic endospore-forming bacteria isolated from a pharmaceutical facility. J. Microbiol. Meth., v. 194, p. 106419, 2022.
COSTA, L. V.; et al. Bacillus lumedeiriae sp. nov., a Gram-Positive, Spore-Forming Rod Isolated from a Pharmaceutical Facility Production Environment and Added to the MALDI Biotyper® Database. Microorganisms, v. 12, n. 12, p. 2507, 2024.
COSTA, A. S. et al. Standardization of an Effective Disinfection Methodology Against Microorganisms Isolated from a Pharmaceutical Industry Facility as a Contamination Control Strategy. Standards, v. 6, n. 2, p. 22, 2026.
DA SILVA, M.; CHAME, M.; MORATELLI, R. Fiocruz Biological Collections: strengthening Brazil's biodiversity knowledge and scientific applications opportunities. Biodiversity Data Journal, v. 8, p. e53607, 2020.
DE MIRANDA, R. V. S. L. et al. Identification of Sutcliffiella horikoshii strains in an immunobiological pharmaceutical industry facility. Lett. Appl. Microbiol., v. 76, n. 5, p. ovad056, 2023.
DE SOUZA, P. A. et al. Application and Limitations of 16S rRNA Gene Sequencing for Identifying WHO Priority Pathogenic Gram-Negative Bacilli. Infect Drug Resist., v. 18, p. 6353-6375, 2025.
EUROPEAN MEDICINES AGENCY (EMA). The Rules Governing Medicinal Products in the European Union. Volume 4: European Union Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Annex 1: Manufacture of Sterile Medicinal Products. Bruxelas, 2022.
GÖKER, M. et al. List of Recommended Names for bacteria of medical importance: report of the Ad Hoc Committee on Mitigating Changes in Prokaryotic Nomenclature. Int. J. Syst. Evol. Microbiol., v. 75, p. 6943, 2025.
GRUNDMANN, H.; HORI, S.; TANNER, G. Determining confidence intervals when measuring genetic diversity and the discriminatory abilities of typing methods for microorganisms. Journal of Clinical Microbiology, v. 39, n. 11, p. 4190–4192, 2001.
HUNTER, P. R.; GASTON, M. A. Numerical index of the discriminatory ability of typing systems: an application of Simpson's index of diversity. Journal of Clinical Microbiology, v. 26, n. 11, p. 2465–2466, 1988.
KREMER, T.; PATEL R. Correlation between Environmental Monitoring and Product Bioburden. Biomed Instrum Technol, v.53, n. s2, p. 32-37, 2019.
LI, Q. et al. Leveraging whole-genome sequencing for microbial contamination tracking and risk assessment in pharmaceutical manufacturing. Front. Microbiol, v. 17, p. 1807989, 2026.
MATTOSO, J. M. V. et al. 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 J. Pharm. Sci. Technol., v. 79, n. 2, p. 125-156, 2025.
NUNES RAMOS, J. et al. Challenges in the identification of environmental bacterial isolates from a pharmaceutical industry facility by 16S rRNA gene sequences. DNA, v. 5, n. 3, p. 33, 2025.
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD). OECD Best Practice Guidelines for Biological Resource Centres. Paris: Organisation for Economic Co-operation and Development, 2007.
RAMOS, V. B. A.; et al. Desenvolvimento de classificação da criticidade de bactérias em monitoramento ambiental de indústria farmacêutica de imunobiológicos. In: SIMPÓSIO DE BIOSSEGURANÇA E BIOPROTEÇÃO, 1.; SEMANA DA QUALIDADE DE BIO-MANGUINHOS, 11., 2024, Rio de Janeiro. Anais... Rio de Janeiro: Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos/Fiocruz), 2024. 1 p.
RAMOS, J. N.; et al. Genome-based taxonomic characterization of Lederbergia fracalanzzae sp. nov., a novel species isolated from a pharmaceutical industry facility and expansion of the MALDI-TOF/MS database. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 10., 2026. Rio de Janeiro. Annals [...]. Rio de Janeiro: Bio-Manguinhos, 2026. p. 229.
RHODES, V. P. et al. Evaluation of the efficacy of different sanitizers on the surface of specific pathogens free eggs. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 9., 2025. Rio de Janeiro. Annals... Rio de Janeiro: Bio-Manguinhos, 2025. p. 156.
RHODES, Vinicius Pessanha et al. Evaluation of microorganisms recovery capacity in different surfaces using Quantiswab aiming to implement in environmental monitoring of Pharmaceutical industries facilities. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 10., 2026. Rio de Janeiro. Annals [...]. Rio de Janeiro: Bio-Manguinhos, 2026. p. 216.
SHERABA, N. S.; YASSIN, A. S.; AMIN, M. A. High-throughput molecular identification of Staphylococcus spp. isolated from a clean room facility in an environmental monitoring program. BMC Res. Notes, v. 3, n. 1, p. 278, 2010.
SILVA-SANTANA, G. et al. Pharmaceutical contamination by biofilms formed of the Burkholderia cepacia complex: public health risks. Processes, v. 13, p. 1270, 2025.
SOARES, G.; AMORIM-NETO, D. P.; COGO-MÜLLER, K. Culturable microbiological profile of a non-sterile drugs pharmaceutical production environment. Braz. J. Pharm. Sci., v. 60, p. e23664, 2024.
SONG, M. et al. A comprehensive technology strategy for microbiological identification in a pharmaceutical facility: a case study. Front. Microbiol., v. 15, p. 1327175, 2024.
SUTTON, S. The environmental monitoring program in a GMP environment. Journal of GXP Compliance, v. 14, n. 3, p. 22–30, 2010.
SUTTON, S. Microbiology and environmental monitoring in aseptic processing. American Pharmaceutical Review, v. 15, n. 5, p. 18–25, 2012.
UNITED STATES PHARMACOPEIA. <1116> Microbiological control and monitoring of aseptic processing environments. In: UNITED STATES PHARMACOPEIA. United States Pharmacopeia and National Formulary (USP–NF). Rockville: United States Pharmacopeial Convention, 2024.
UNITED STATES PHARMACOPEIA. <1113> Microbial Characterization, Identification, and Strain Typing. In: UNITED STATES PHARMACOPEIA. United States Pharmacopeia and National Formulary (USP–NF). Rockville: United States Pharmacopeial Convention, 2025.
VALADÃO, T. B. et al. Evaluation of the Nutritive Capacity of Soybean Tryptic Agar for Environmental Control in the Pharmaceutical Industry. Revista Cubana de Farmacia, v. 56, n. 4, p. e1012, 2023
VASCONCELLOS, L. et al. Phenotypical and molecular characterization of Acinetobacter spp. isolated from a pharmaceutical facility. Lett. Appl. Microbiol., v. 77, n. 5, p. ovad101, 2023.
VASCONCELLOS, L. et al. Phenotypical and molecular characterization of Pseudomonas spp. isolated from a pharmaceutical facility. Processes, v. 14, n. 2, p. 231, 2026.
WORLD FEDERATION FOR CULTURE COLLECTIONS (WFCC). Guidelines for the establishment and operation of collections of microorganisms. Utrecht: World Federation for Culture Collections, 2010.
Publicado
2026-08-22
Como Citar
SILVA, D. V. DA; VIEIRA, ÉRICA M. D.; BRANDÃO, M. L. L.; VIEIRA, V. V.; COSTA, L. V. DA; MIRANDA, C. A. C. DE. Caracterização de bactérias isoladas de ambientes de produção farmacêutica e depósito na coleção de bactérias do ambiente e saúde (FIOCRUZ/CBAS). Revista Científica do UBM, v. 28, n. 55, p. 262-280, 22 ago. 2026.
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