Desafios de identificação e controle de Ralstonia pickettii na indústria farmacêutica: uma revisão integrativa da literatura
Palavras-chave:
Ralstonia pickettii, Indústria farmacêutica, Surto, Controle de qualidade microbiológico
Resumo
Contaminações microbianas na indústria farmacêutica geram riscos à saúde e prejuízos econômicos. Nesse cenário, Ralstonia pickettii é um patógeno relevante em surtos por produtos contaminados. Sua detecção frequente em sistemas hídricos evidencia sua resiliência ambiental. Este estudo discute a relevância de R. pickettii em sistemas de água e produtos farmacêuticos, enfatizando a identificação e tipificação na prevenção de desvios de processo. A revisão integrativa no PubMed, SciELO e Google Scholar (2016–2026) incluiu artigos originais sobre surtos nosocomiais, controle de qualidade da água e métodos de identificação e tipagem microbiana; revisões, literatura cinzenta e duplicatas foram excluídas. Dez estudos selecionados revelaram a dispersão global de R. pickettii, predominando na Ásia (50%) e Europa (40%). Os principais reservatórios identificados foram soluções salinas (60%), medicamentos (20%), água purificada (10%) e meio de cultura/bulk/torneira (10%), evidenciando sua persistência na fabricação. Na identificação, a espectrometria de massas por dessorção/ionização a laser assistida por matriz - tempo de voo (MALDI-TOF MS) foi a ferramenta central (70%), seguida por sequenciamento do genoma completo (SGC; 40%). Clonalidade e rastreamento de fontes foram avaliados principalmente por eletroforese em gel de campo pulsado (PFGE; 50%) e SGC (40%). A presença de R. pickettii estabelece um elo crítico entre falhas no controle de sistemas hídricos e infecções. A caracterização molecular avançada é essencial para direcionar ações corretivas e preventivas e otimizar medidas de controle, como a rotação de desinfetantes e a validação de utilidades, assegurando o cumprimento das boas práticas de fabricação.Referências
ANDERSON, R. L. et al. Factors associated with Pseudomonas pickettii intrinsic contamination of commercial respiratory therapy solutions marketed as sterile. Appl. Environ. Microbiol., v. 50, n. 6, p. 1343-1348, 1985.
BAKER, M. A.; et al. Ralstonia pickettii and Pseudomonas aeruginosa bloodstream infections associated with contaminated extracorporeal membrane oxygenation water heater devices. Clin. Infect. Dis., v. 75, n. 10, p. 1838-1840, 2022.
BASSO, M. et al. A case of persistent bacteremia by Ralstonia mannitolilytica and Ralstonia pickettii in an intensive care unit. Infect. Drug Resist., v. 12, p. 2391-2395, 2019.
BATARILO, I. et al. Oxacillinases and antimicrobial susceptibility of Ralstonia pickettii from pharmaceutical water systems in Croatia. Arh. Hig. Rada Toksikol., v. 73, n. 2, p. 103-109, 2022.
BERNAUS, C. G. Risk Assessment and Regulatory Response to Systematic Pharmaceutical Quality Failures: Lessons from Argentina's Contaminated Fentanyl and Dexamethasone Crisis. J. Regul. Sci., v. 13, n. 1, 2025.
BRASIL. Agência Nacional de Vigilância Sanitária. Farmacopeia brasileira: 7.ed. Brasília: ANVISA, 2024. 1072 p. v.1
CHEN, Y. Y. et al. An outbreak of Ralstonia pickettii bloodstream infection associated with an intrinsically contaminated normal saline solution. Infect. Control Hosp. Epidemiol., v. 38, n. 4, p. 444-448, 2017.
CHOUDHURY, H.; et al. An outbreak of Ralstonia pickettii endophthalmitis following intravitreal methotrexate injection. Clin. Ophthalmol., v. 9, p. 1117-1120, 2015.
CLSI – Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition. CLSI Supplement M100. Wayne, PA: CLSI; 2024.
ÇELEN, M. K. et al. Central line-associated bloodstream infection outbreak related to Ralstonia pickettii-contaminated saline in a pediatric hematopoietic stem cell transplant center. J. Hosp. Infect., v. 118, p. 45-52, 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.
de la TORRE B. G.; ALBERICIO, F. The Pharmaceutical Industry in 2024: An Analysis of the FDA Drug Approvals from the Perspective of Molecules. Molecules, v. 30, n. 3, p. 482, 2025.
DEMIRDAG, Y. et al. An outbreak of Ralstonia pickettii bloodstream infection among pediatric leukemia patients. Pediatr. Infect. Dis. J., v. 41, n. 9, p. 370-373, 2022.
DESAI, M.; NJOKU, A.; NIMO-SEFAH, L. Comparing Environmental Policies to Reduce Pharmaceutical Pollution and Address Disparities. Int. J. Environ. Res. Public Health, v. 19, n. 14, p. 8292, 2022.
EUCAST. European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters, version 14.3, 2024. Disponível em: https://www.eucast.org/clinical_breakpoints/. Acesso em: 08 set. 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. Bruxelles, 2022.
FLUIT, A. C. et al. Characterization of clinical Ralstonia strains and their taxonomic position. Antonie Van Leeuwenhoek, v. 114, n. 10, p. 1721-1733, 2021.
FOOD AND DRUG ADMINISTRATION (FDA). Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. Bethesda, MD, USA, 2004.
FORERO, J. et al. Outbreak of Ralstonia pickettii bacteremia caused by contaminated hydromorphone in a universitary hospital in Bogota, Colombia. Infectio, v. 25, n. 3, p. 185-190, 2021.
GAOH, S. et al. A comparative metagenomic analysis of specified microorganisms in groundwater for non-sterilized pharmaceutical products. Curr. Microbiol., v. 81, n. 9, p. 273, 2024.
GHIJS, S.; WYNENDAELE, E.; DE SPIEGELEER, B. The continuing challenge of drug recalls: insights from a ten-year FDA data analysis. J. Pharm. Biomed. Anal., v. 249, p. 116349, 2024.
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, art. 6943, 2025.
GUPTA, S.; DESAI, S. Environmental impact and regulatory compliance: a comprehensive approach in managing institutional pharmaceutical waste. Int. J. Pharm. Pharm. Sci., v. 16, n.6, p. 14–18, 2024.
HOLMES, B. et al. Burkholderia pickettii sp. nov., a new name for the species previously known as Pseudomonas pickettii. Int. J. Syst. Bacteriol., v. 43, n. 2, p. 366–366, 1993.
JESUS, P. R. et al. Monitoring the quality of the water used in mobile dialysis services in intensive care units in the city of Rio de Janeiro. J. Bras. Nefrol., v. 44, n. 1, p. 32-41, 2022.
JIMENEZ, L. et al. Analysis of FDA enforcement reports (2012–2019) to determine the microbial diversity in contaminated non-sterile and sterile drugs. Am. Pharm. Rev., v. 21, p. 48–73, 2019.
JONES, K. E. et al. Global trends in emerging infectious diseases. Nature, v. 451, n. 7181, p. 990-993, 2008.
KRONE, M. et al. Ralstonia pickettii bloodstream infections with potential genomic link to internationally distributed contaminated saline solution, Germany, October 2023. Euro Surveill., v. 29, n. 3, p. 2400010, 2024.
KUBOTA, K. A. et al. PulseNet and the Changing Paradigm of Laboratory-Based Surveillance for Foodborne Diseases. Public Health Rep., v. 134, n. 2_suppl, p. 22S-28S, 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.
MENGHWAR, H. S. et al. Application of cgMLST in outbreak analysis and surveillance. Pathogens, v. 11, n. 3, p. 351, 2022.
MOREIRA, B. M. et al. Ralstonia pickettii and Burkholderia cepacia complex bloodstream infections related to infusion of contaminated water for injection. J. Hosp. Infect., v. 60, n. 1, p. 51-55, 2005.
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.
ORME, J.; et al. Native valve endocarditis due to Ralstonia pickettii: a case report and literature review. Case Rep. Infect. Dis., v. 2015, p. 324675, 2015.
PATEL, R. et al. A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023. Drug Discov Today. V. 29, n. 6, p. 103993, 2024.
PELLEGRINO, F. L. et al. Ralstonia pickettii bloodstream infections at a Brazilian cancer institution. Curr. Microbiol., v. 56, n. 3, p. 219-223, 2008.
PEREZ-ALEMAN, P.; FERRETTI, T. Creating innovation capabilities for improving global health: inventing technology for neglected tropical diseases in Brazil. J. Int. Bus. Policy, v. 6, n. 1, p. 84–114, 2023.
RAJACHANDRAN, K. et al. Outbreak of nosocomial infection from an unusual source. Indian J. Crit. Care Med., v. 26, n. 9, p. 1042-1044, 2022.
RALSTON, E.; PALLERONI, N. J.; DOUDOROFF, M. Pseudomonas pickettii, a new species of clinical origin related to Pseudomonas solanacearum. Int. J. Syst. Bacteriol., v. 23, p. 15–19, 1973.
ROSS, B. et al. Outbreak with Ralstonia pickettii caused by contaminated magnesium vials. Dtsch. Med. Wochenschr., v. 139, n. 7, p. 323-326, 2014.
RYAN, M. P.; ADLEY, C. C. Ralstonia spp.: emerging global opportunistic pathogens. Eur. J. Clin. Microbiol. Infect. Dis., v. 33, n. 3, p. 291-304, 2014.
RYAN, M. P.; PEMBROKE, J. T.; ADLEY, C. C. Ralstonia pickettii: a persistent gram-negative nosocomial infectious organism. J. Hosp. Infect., v. 62, n. 3, p. 278-284, 2006.
SANDFORT, M. et al. Nosocomial Outbreak of Ralstonia pickettii Infections Likely Linked to Saline Solutions in Germany from August 2023 to March 2024—Challenges in Medical Product-Related Outbreaks. Microorganisms, v. 13, n. 9, p. 2102, 2025.
SAUNDERS, M. et al. Outbreak of Ralstonia pickettii associated with contamination of saline products distributed internationally, the United Kingdom, 2024. Euro Surveill., v. 29, n. 27, p. 2400384, 2024.
SCHNETZINGER, M. et al. Bacterial contamination of water used as thermal transfer fluid in fluid-warming devices. J. Hosp. Infect., v. 141, p. 49-54, 2023.
SHARMA, A.; GAMTA, V.; LUTHRA, G. The importance of good manufacturing practices (GMP) in the healthcare industry. J. Pharm. Res. Int., v. 35, n. 18, p. 75–90, 2023.
SHENG, Z. et al. Molecular epidemiological and clinical infection characteristics analysis of Ralstonia. Eur. J. Clin. Microbiol. Infect. Dis., v. 43, n. 6, p. 1161-1170, 2024.
SIMAR, S. R.; HANSON, B. M.; ARIAS, C. A. Techniques in bacterial strain typing: past, present, and future. Curr. Opin. Infect. Dis., v. 34, n. 4, p. 339-345, 2021.
SONG, M. et al. A comprehensive technology strategy for microbial identification and contamination investigation in the sterile drug manufacturing facility - a case study. Front. Microbiol., v. 15, p. 1327175, 2024.
SOUZA, P. A. et al. Evaluation of Antimicrobial Resistance Patterns of Pseudomonas aeruginosa Strains Isolated among COVID-19 Patients in Brazil Typed by Fourier-Transform Infrared Spectroscopy. Life (Basel), v. 14, n. 9, p. 1079, 2024.
SOUZA, P. A. et al. Evaluation of biofilm formation, antimicrobial pattern, and typing of Stenotrophomonas maltophilia isolated from clinical sources in Brazil. Braz J Microbiol, v. 56, n. 3, p. 1861-1871, 2025a.
SOUZA, P. A. et al. Phenotypical and Molecular Characterization of Acinetobacter baumannii Isolated from Hospitalized Patients During the COVID-19 Pandemic in Brazil. Life (Basel), v. 15, n. 4, p. 623, 2025b.
STELZMUELLER, I. et al. Ralstonia pickettii - innocent bystander or a potential threat? Clin. Microbiol. Infect., v. 12, n. 2, p. 99–101, 2006.
SUNDARAM, S. et al. Application of membrane filtration for removal of diminutive bioburden organisms in pharmaceutical products and processes. PDA J. Pharm. Sci. Technol., v. 53, n. 4, p. 186–201, 1999.
UNITED STATES PHARMACOPEIA. USP-NF Online. Rockville: United States Pharmacopeial Convention, 2026. Disponível em: https://online.uspnf.com. Acesso em: 01 jul 2026.
VASCONCELLOS, L. et al. Phenotypical and molecular characterization of Acinetobacter spp. isolated from a pharmaceutical facility. Lett. Appl. Microbiol., v. 76, p. ovad101, 2023.
VASCONCELLOS, Luiza et al. Phenotypical and molecular characterization of Pseudomonas spp. isolated from a pharmaceutical facility. Processes, v. 14, n. 2, p. 231, 2026.
VIANA-CÁRDENAS, E. et al. A large multicenter Ralstonia pickettii outbreak in critically ill patients during the COVID-19 pandemic: epidemiological and clinical characteristics of 66 cases. J. Infect. Prev., v. 25, n. 3, p. 85–88, 2024.
YABUUCHI, E. et al. Transfer of two Burkholderia and an Alcaligenes species to Ralstonia gen. nov.: proposal of Ralstonia pickettii (Ralston, Palleroni and Doudoroff 1973) comb. nov., Ralstonia solanacearum (Smith 1896) comb. nov. and Ralstonia eutropha (Davis 1969) comb. nov. Microbiol. Immunol., v. 39, n. 11, p. 897–904, 1995.
YUAN, C. et al. Genomic analysis of Ralstonia pickettii reveals the genetic features for potential pathogenicity and adaptive evolution in drinking water. Front. Microbiol., v. 14, p. 1272636, 2024.
BAKER, M. A.; et al. Ralstonia pickettii and Pseudomonas aeruginosa bloodstream infections associated with contaminated extracorporeal membrane oxygenation water heater devices. Clin. Infect. Dis., v. 75, n. 10, p. 1838-1840, 2022.
BASSO, M. et al. A case of persistent bacteremia by Ralstonia mannitolilytica and Ralstonia pickettii in an intensive care unit. Infect. Drug Resist., v. 12, p. 2391-2395, 2019.
BATARILO, I. et al. Oxacillinases and antimicrobial susceptibility of Ralstonia pickettii from pharmaceutical water systems in Croatia. Arh. Hig. Rada Toksikol., v. 73, n. 2, p. 103-109, 2022.
BERNAUS, C. G. Risk Assessment and Regulatory Response to Systematic Pharmaceutical Quality Failures: Lessons from Argentina's Contaminated Fentanyl and Dexamethasone Crisis. J. Regul. Sci., v. 13, n. 1, 2025.
BRASIL. Agência Nacional de Vigilância Sanitária. Farmacopeia brasileira: 7.ed. Brasília: ANVISA, 2024. 1072 p. v.1
CHEN, Y. Y. et al. An outbreak of Ralstonia pickettii bloodstream infection associated with an intrinsically contaminated normal saline solution. Infect. Control Hosp. Epidemiol., v. 38, n. 4, p. 444-448, 2017.
CHOUDHURY, H.; et al. An outbreak of Ralstonia pickettii endophthalmitis following intravitreal methotrexate injection. Clin. Ophthalmol., v. 9, p. 1117-1120, 2015.
CLSI – Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition. CLSI Supplement M100. Wayne, PA: CLSI; 2024.
ÇELEN, M. K. et al. Central line-associated bloodstream infection outbreak related to Ralstonia pickettii-contaminated saline in a pediatric hematopoietic stem cell transplant center. J. Hosp. Infect., v. 118, p. 45-52, 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.
de la TORRE B. G.; ALBERICIO, F. The Pharmaceutical Industry in 2024: An Analysis of the FDA Drug Approvals from the Perspective of Molecules. Molecules, v. 30, n. 3, p. 482, 2025.
DEMIRDAG, Y. et al. An outbreak of Ralstonia pickettii bloodstream infection among pediatric leukemia patients. Pediatr. Infect. Dis. J., v. 41, n. 9, p. 370-373, 2022.
DESAI, M.; NJOKU, A.; NIMO-SEFAH, L. Comparing Environmental Policies to Reduce Pharmaceutical Pollution and Address Disparities. Int. J. Environ. Res. Public Health, v. 19, n. 14, p. 8292, 2022.
EUCAST. European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters, version 14.3, 2024. Disponível em: https://www.eucast.org/clinical_breakpoints/. Acesso em: 08 set. 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. Bruxelles, 2022.
FLUIT, A. C. et al. Characterization of clinical Ralstonia strains and their taxonomic position. Antonie Van Leeuwenhoek, v. 114, n. 10, p. 1721-1733, 2021.
FOOD AND DRUG ADMINISTRATION (FDA). Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. Bethesda, MD, USA, 2004.
FORERO, J. et al. Outbreak of Ralstonia pickettii bacteremia caused by contaminated hydromorphone in a universitary hospital in Bogota, Colombia. Infectio, v. 25, n. 3, p. 185-190, 2021.
GAOH, S. et al. A comparative metagenomic analysis of specified microorganisms in groundwater for non-sterilized pharmaceutical products. Curr. Microbiol., v. 81, n. 9, p. 273, 2024.
GHIJS, S.; WYNENDAELE, E.; DE SPIEGELEER, B. The continuing challenge of drug recalls: insights from a ten-year FDA data analysis. J. Pharm. Biomed. Anal., v. 249, p. 116349, 2024.
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, art. 6943, 2025.
GUPTA, S.; DESAI, S. Environmental impact and regulatory compliance: a comprehensive approach in managing institutional pharmaceutical waste. Int. J. Pharm. Pharm. Sci., v. 16, n.6, p. 14–18, 2024.
HOLMES, B. et al. Burkholderia pickettii sp. nov., a new name for the species previously known as Pseudomonas pickettii. Int. J. Syst. Bacteriol., v. 43, n. 2, p. 366–366, 1993.
JESUS, P. R. et al. Monitoring the quality of the water used in mobile dialysis services in intensive care units in the city of Rio de Janeiro. J. Bras. Nefrol., v. 44, n. 1, p. 32-41, 2022.
JIMENEZ, L. et al. Analysis of FDA enforcement reports (2012–2019) to determine the microbial diversity in contaminated non-sterile and sterile drugs. Am. Pharm. Rev., v. 21, p. 48–73, 2019.
JONES, K. E. et al. Global trends in emerging infectious diseases. Nature, v. 451, n. 7181, p. 990-993, 2008.
KRONE, M. et al. Ralstonia pickettii bloodstream infections with potential genomic link to internationally distributed contaminated saline solution, Germany, October 2023. Euro Surveill., v. 29, n. 3, p. 2400010, 2024.
KUBOTA, K. A. et al. PulseNet and the Changing Paradigm of Laboratory-Based Surveillance for Foodborne Diseases. Public Health Rep., v. 134, n. 2_suppl, p. 22S-28S, 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.
MENGHWAR, H. S. et al. Application of cgMLST in outbreak analysis and surveillance. Pathogens, v. 11, n. 3, p. 351, 2022.
MOREIRA, B. M. et al. Ralstonia pickettii and Burkholderia cepacia complex bloodstream infections related to infusion of contaminated water for injection. J. Hosp. Infect., v. 60, n. 1, p. 51-55, 2005.
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.
ORME, J.; et al. Native valve endocarditis due to Ralstonia pickettii: a case report and literature review. Case Rep. Infect. Dis., v. 2015, p. 324675, 2015.
PATEL, R. et al. A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023. Drug Discov Today. V. 29, n. 6, p. 103993, 2024.
PELLEGRINO, F. L. et al. Ralstonia pickettii bloodstream infections at a Brazilian cancer institution. Curr. Microbiol., v. 56, n. 3, p. 219-223, 2008.
PEREZ-ALEMAN, P.; FERRETTI, T. Creating innovation capabilities for improving global health: inventing technology for neglected tropical diseases in Brazil. J. Int. Bus. Policy, v. 6, n. 1, p. 84–114, 2023.
RAJACHANDRAN, K. et al. Outbreak of nosocomial infection from an unusual source. Indian J. Crit. Care Med., v. 26, n. 9, p. 1042-1044, 2022.
RALSTON, E.; PALLERONI, N. J.; DOUDOROFF, M. Pseudomonas pickettii, a new species of clinical origin related to Pseudomonas solanacearum. Int. J. Syst. Bacteriol., v. 23, p. 15–19, 1973.
ROSS, B. et al. Outbreak with Ralstonia pickettii caused by contaminated magnesium vials. Dtsch. Med. Wochenschr., v. 139, n. 7, p. 323-326, 2014.
RYAN, M. P.; ADLEY, C. C. Ralstonia spp.: emerging global opportunistic pathogens. Eur. J. Clin. Microbiol. Infect. Dis., v. 33, n. 3, p. 291-304, 2014.
RYAN, M. P.; PEMBROKE, J. T.; ADLEY, C. C. Ralstonia pickettii: a persistent gram-negative nosocomial infectious organism. J. Hosp. Infect., v. 62, n. 3, p. 278-284, 2006.
SANDFORT, M. et al. Nosocomial Outbreak of Ralstonia pickettii Infections Likely Linked to Saline Solutions in Germany from August 2023 to March 2024—Challenges in Medical Product-Related Outbreaks. Microorganisms, v. 13, n. 9, p. 2102, 2025.
SAUNDERS, M. et al. Outbreak of Ralstonia pickettii associated with contamination of saline products distributed internationally, the United Kingdom, 2024. Euro Surveill., v. 29, n. 27, p. 2400384, 2024.
SCHNETZINGER, M. et al. Bacterial contamination of water used as thermal transfer fluid in fluid-warming devices. J. Hosp. Infect., v. 141, p. 49-54, 2023.
SHARMA, A.; GAMTA, V.; LUTHRA, G. The importance of good manufacturing practices (GMP) in the healthcare industry. J. Pharm. Res. Int., v. 35, n. 18, p. 75–90, 2023.
SHENG, Z. et al. Molecular epidemiological and clinical infection characteristics analysis of Ralstonia. Eur. J. Clin. Microbiol. Infect. Dis., v. 43, n. 6, p. 1161-1170, 2024.
SIMAR, S. R.; HANSON, B. M.; ARIAS, C. A. Techniques in bacterial strain typing: past, present, and future. Curr. Opin. Infect. Dis., v. 34, n. 4, p. 339-345, 2021.
SONG, M. et al. A comprehensive technology strategy for microbial identification and contamination investigation in the sterile drug manufacturing facility - a case study. Front. Microbiol., v. 15, p. 1327175, 2024.
SOUZA, P. A. et al. Evaluation of Antimicrobial Resistance Patterns of Pseudomonas aeruginosa Strains Isolated among COVID-19 Patients in Brazil Typed by Fourier-Transform Infrared Spectroscopy. Life (Basel), v. 14, n. 9, p. 1079, 2024.
SOUZA, P. A. et al. Evaluation of biofilm formation, antimicrobial pattern, and typing of Stenotrophomonas maltophilia isolated from clinical sources in Brazil. Braz J Microbiol, v. 56, n. 3, p. 1861-1871, 2025a.
SOUZA, P. A. et al. Phenotypical and Molecular Characterization of Acinetobacter baumannii Isolated from Hospitalized Patients During the COVID-19 Pandemic in Brazil. Life (Basel), v. 15, n. 4, p. 623, 2025b.
STELZMUELLER, I. et al. Ralstonia pickettii - innocent bystander or a potential threat? Clin. Microbiol. Infect., v. 12, n. 2, p. 99–101, 2006.
SUNDARAM, S. et al. Application of membrane filtration for removal of diminutive bioburden organisms in pharmaceutical products and processes. PDA J. Pharm. Sci. Technol., v. 53, n. 4, p. 186–201, 1999.
UNITED STATES PHARMACOPEIA. USP-NF Online. Rockville: United States Pharmacopeial Convention, 2026. Disponível em: https://online.uspnf.com. Acesso em: 01 jul 2026.
VASCONCELLOS, L. et al. Phenotypical and molecular characterization of Acinetobacter spp. isolated from a pharmaceutical facility. Lett. Appl. Microbiol., v. 76, p. ovad101, 2023.
VASCONCELLOS, Luiza et al. Phenotypical and molecular characterization of Pseudomonas spp. isolated from a pharmaceutical facility. Processes, v. 14, n. 2, p. 231, 2026.
VIANA-CÁRDENAS, E. et al. A large multicenter Ralstonia pickettii outbreak in critically ill patients during the COVID-19 pandemic: epidemiological and clinical characteristics of 66 cases. J. Infect. Prev., v. 25, n. 3, p. 85–88, 2024.
YABUUCHI, E. et al. Transfer of two Burkholderia and an Alcaligenes species to Ralstonia gen. nov.: proposal of Ralstonia pickettii (Ralston, Palleroni and Doudoroff 1973) comb. nov., Ralstonia solanacearum (Smith 1896) comb. nov. and Ralstonia eutropha (Davis 1969) comb. nov. Microbiol. Immunol., v. 39, n. 11, p. 897–904, 1995.
YUAN, C. et al. Genomic analysis of Ralstonia pickettii reveals the genetic features for potential pathogenicity and adaptive evolution in drinking water. Front. Microbiol., v. 14, p. 1272636, 2024.
Publicado
2026-08-23
Como Citar
SILVA, I. R. DA; COSTA, L. V. DA; VILLAS BÔAS, M. H. S.; BRANDÃO, M. L. L. Desafios de identificação e controle de Ralstonia pickettii na indústria farmacêutica: uma revisão integrativa da literatura. Revista Científica do UBM, v. 28, n. 55, p. 340-358, 23 ago. 2026.
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