RESUMO
Microbiological contamination may cause microbial proliferation and consequently additional problems for pharmaceutical companies through production stoppage, product contamination, investigations of process deviations, out-of-specification results and product disposal. This is one of the major concerns of the regulatory health agencies. Microbiological load (bioburden) may represent a potential risk for patients if the sterilization process is not effective and/or due to the production of toxins. Although bioburden can be eliminated by terminal sterilization or filtration processes, it is important to monitor the amount and determine the identity and characteristics of the microorganisms present prior to final processing. The application of microorganism identification systems is crucial for identifying the type of contamination, which can be extremely useful for investigating. The aim of this study was to evaluate the profiles of microorganisms identified in bioburden assays from solutions, culture medias, and products (SCP) from a pharmaceutical industry facility. From 2018-2020, a total of 1,078 samples from 857 different lots of SCP were analyzed and isolated microorganisms were identified. A prefiltering step was included after March 2020, in order to reduce the bioburden before sterilizing filtration. Criteria for the definition and management of microorganisms identified were evaluated after an integrative bibliographic review, and three groups were proposed (critical, objectionable, and nonobjectionable microorganisms). For the samples that did not include prefiltering (n=636), 227 (35.7%) presented microbial growth. For those that included prefiltering, before prefiltering (n=221), 60.6% presented microbial growth, and after prefiltering, this value was reduced to 4.1%, which can be attributed to a contamination during the sampling or a wrong filtering. From the samples that presented microbial growth, 678 microorganisms were identified as bacteria and 59 as molds and yeasts. A total of 120 microorganisms (56 and 27 Gram-positive and negative bacteria, respectively, 31 yeasts, and six filamentous molds) could not be identified, and the remaining microorganisms were classified as objectionable (n=507; 82.2%), nonobjectionable (n=103; 16.7%) and critical (n=7; 1.1%). Most of the bioburden species (>80.0%) were considered objectionable microorganisms. A process for classification and management of bioburden analysis results based on a literature review of pathogenic and physiological characteristics of the microorganisms was proposed.
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The zoonotic visceral leishmaniasis is caused by the protozoan Leishmania infantum and dogs are reservoirs for this parasite. For the diagnosis of Leishmania at the species level in dogs in formalin-fixed, paraffin-embedded skin (FFPES) samples, colorimetric in situ hybridization (CISH) and quantitative real-time polymerase chain reaction (qPCR) are options, but their sensitivities are not well established. Therefore, the aim of this study was to determine the sensitivity of these two techniques in FFPES for the diagnosis of the L. infantum infection in dogs using culture as the reference standard. The FFPES of 48 dogs with cutaneous infection by L. infantum confirmed by culture and by multilocus enzyme electrophoresis were examined by CISH and qPCR using specific probes for L. infantum. The sensitivities of qPCR, CISH and their combination were, respectively, 77.0%, 58.0% and 83.3%. The sensitivities of qPCR in dogs with and without clinical signs were, respectively, 74.2% and 82.4%. The sensitivities of CISH in dogs with and without clinical signs were, respectively, 61.3% and 52.9%. The CISH and qPCR showed satisfactory sensitivities for the diagnosis of L. infantum in the FFPES of dogs, even in dogs without clinical signs, and their combination increases the sensitivity for this diagnosis.
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Characterizing microorganisms according to different criteria is useful when investigating sources of microbiological contamination in the pharmaceutical industry. The aim of this study was to characterize 38 Acinetobacter baumannii complex strains isolated from a biopharmaceutical industry by 16S rRNA sequencing, matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF/MS), multilocus sequence typing (MLST), antimicrobial susceptibility profile, biofilm formation, and sensibility to disinfectants. Thirty-three (86.9%) strains were identified by 16S rRNA gene sequencing as A. seifertii/pitti/nosocomialis/lactucae, four (10.5%) as A. baumannii, and one (2.6%) as A. vivianii/courvalini. MALDI-TOF/MS did not identify one strain, and incorrectly identified 30/37 (81.1%) strains as A. baumannii. Strains were assigned to 12 different STs, of which nine were newly defined in this study (STs 2091-2099). Twenty-six (68.4%) strains showed resistance to amikacin and gentamicin. Thirty-three (86.8%) strains were classified as moderately or strongly adherent on polystyrene. Alcohol 70%/15 min and quaternary ammonium 0.08%/20 min were not able to eliminate the biofilm formed, but sodium hypochlorite 0.1%/15 min was efficient. In conclusion, improved methods are needed to improve the identification of Acinetobacter strains in pharmaceutical industries. This organism is of particular concern as it forms recalcitrant biofilms, leading to persistence in the manufacturing environment and increased risk of product contamination.
Assuntos
Acinetobacter baumannii , Tipagem de Sequências Multilocus , RNA Ribossômico 16S/genética , Acinetobacter baumannii/genética , Amicacina , Preparações FarmacêuticasRESUMO
The attenuated yellow fever vaccine (YFV) is offered free of charge to the Brazilian population through the National Immunization Program (NIP). One of the specifications for quality control analyses of the vaccine is the potency determination. This test determines the number of plaque forming units (PFU) in Vero cells. In order to validate the results, the reference material (RM) is analysed in parallel with an established reference vaccine. The aim of this study was to establish certified RM for use as an internal control in the potency assay for the production chain of YFV. The candidate RM homogeneity and stability were determined, and characterized by a collaborative study for further certification. The RM was considered sufficiently homogeneous with average 4.68 log10 IU/HD and stable at (-20 ± 10) ºC and (22.5 ± 2.5) ºC for 715 and 183 days, respectively. When reconstituted and stored in aliquots of 0.6 mL, it was stable at (-20 ± 10) ºC for eight days. But it was not stable at (5 ± 3) ºC for three days. In a collaborative study, two independents' laboratories gave an averaged value of 4.56 ± 0.030 log10 IU/HD. After determining the expanded uncertainty of homogeneity, stability, and characterization, the certified RM lot: 195VFA020Z presented a property value of 4.56 ± 0.22 log10 IU/HD. It was concluded that the new certified RM can be used in routine analysis of a YFV producer, since it has its property value established and it is stable. The possibility of using it in aliquots after reconstitution will also allow the RM to have a much longer shelf life.
Assuntos
Vacina contra Febre Amarela , Animais , Chlorocebus aethiops , Células Vero , Padrões de Referência , Controle de Qualidade , CertificaçãoRESUMO
OBJECTIVE: Airborne particles are one of the most important factors in the spread of infectious pathogens and must be monitored in healthcare facilities. Viable particles are living microorganisms, whereas non-viable particles do not contain microorganisms but act as transport for viable particles. The effectiveness of ozone in reducing these particles in a non-controlled room and a controlled cleanroom using high-efficiency particles air (HEPA) filter was analyzed in this study. MATERIALS AND METHODS: Viable particles and non-viable particles sized 0.5 and 5 µm were quantified before and after ozonation in two different health environments: non-controlled (group 1) and controlled area, which was associated with a HEPA filtering system (group 2). Active air sampling using a MAS 100 was used to count the number of viable particles, while the number of non-viable particles/m3 was obtained following the manufacturer's recommendations of the Lasair III 310C system. RESULTS: Our results of the viable particles counting were not quantifiable and analyzed using statistical tests. Both groups showed a slight tendency to reduce the number of viable particles after ozonation of the environmental air. A statistically significant reduction of non-viable 5 µm particles after ozonation was observed in both groups (G1: p = 0,009; G2: p = 0,002). Reduction in the non-viable 0.5 µm particles after ozonation was observed only in group 2, associated with the HEPA filter. In group 1, after ozonation, a significant increase in 0.5 µm particles was observed, probably due to the breaking of 5 µm particles by ozone gas. Our results suggest that ozone gas can break 5 µm particles and, when associated with a HEPA filter, increases its effectiveness in removing 0.5 µm particles. CONCLUSION: Considering that 5 µm particles are important in the air transport of microorganisms, their reduction in the environment can be a relevant parameter in controlling the dissemination of infections.
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The article examines health itineraries followed by Brazilian travestis, trans men and trans women in the affirmation of their gender, based on the survey Trans Uerj: Health and Citizenship of Trans People in Brazil. The survey's main objectives were to gauge the trans/travesti population's diversity and sociodemographic profile; and to map the various ways they access their rights as citizens, especially to healthcare services and body modification technologies. Interviewers, mainly trans people and travestis, applied 391 questionnaires in the city of Rio de Janeiro and its metropolitan region to interviewees of different social classes, schooling levels and gender identity configurations, contacted through the interviewers' social networks. For defining respondents' gender identities the survey used an original method based on self-definitions, which were then aggregated into 6 categories for data analysis purposes. This article discusses the multiple strategies used by this trans population in gender affirmation processes to gain access to regulated and/or unregulated use of hormones and surgical procedures.
Assuntos
Identidade de Gênero , Somatotipos , Pessoas Transgênero/estatística & dados numéricos , Transexualidade/cirurgia , Travestilidade/cirurgia , Adolescente , Adulto , Brasil/epidemiologia , Feminino , Acessibilidade aos Serviços de Saúde , Hormônios/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Automedicação , Autorrelato , Apoio Social , Fatores Socioeconômicos , Inquéritos e Questionários , Pessoas Transgênero/legislação & jurisprudência , Transexualidade/classificação , Adulto JovemRESUMO
The article examines health itineraries followed by Brazilian travestis, trans men and trans women in the affirmation of their gender, based on the survey Trans Uerj: Health and Citizenship of Trans People in Brazil. The survey's main objectives were to gauge the trans/travesti population's diversity and sociodemographic profile; and to map the various ways they access their rights as citizens, especially to healthcare services and body modification technologies. Interviewers, mainly trans people and travestis, applied 391 questionnaires in the city of Rio de Janeiro and its metropolitan region to interviewees of different social classes, schooling levels and gender identity configurations, contacted through the interviewers' social networks. For defining respondents' gender identities the survey used an original method based on self-definitions, which were then aggregated into 6 categories for data analysis purposes. This article discusses the multiple strategies used by this trans population in gender affirmation processes to gain access to regulated and/or unregulated use of hormones and surgical procedures.
O artigo examina os itinerários de saúde seguidos por travestis e mulheres e homens trans brasileiros na afirmação do seu próprio gênero, com base no inquérito Trans Uerj: Health and Citizenship of Trans People in Brazil. O inquérito teve como objetivos avaliar a diversidade e o perfil sociodemográfico da população trans/travesti e mapear as diversas maneiras pelas quais garantem seus direitos de cidadania, principalmente nos serviços saúde e em tecnologias de modificação do corpo. Os entrevistadores, majoritariamente pessoas trans e travestis, aplicaram 391 questionários na cidade e Região Metropolitana do Rio de Janeiro, com entrevistados/as de diferentes classes sociais, níveis de escolaridade e configurações de identidade de gênero, contatados através das redes sociais dos entrevistadores. A definição da identidade de gênero dos entrevistados usou um método original baseado nas autodefinições; as definições foram agregadas depois em seis categorias para fins de análise dos dados. O artigo discute as múltiplas estratégias utilizadas pela população trans nos processos de afirmação de gênero para obter acesso ao uso regulado e/ou não regulado de hormônios e procedimentos cirúrgicos.
El artículo examina los itinerarios de salud seguidos por travestis brasileños, hombres trans y mujeres trans para la afirmación de su género, está basado en la encuesta Trans Uerj: Health and Citizenship of Trans People in Brazil. Los objetivos principales de esta encuesta fueron evaluar la diversidad de la población trans/travesti y su perfil sociodemográfico; así como mapear los diferentes caminos gracias a los que consiguen tener acceso a sus derechos como ciudadanos, especialmente en lo que concierne a servicios de salud y técnicas de modificación corporales. Se entrevistaron principalmente a personas trans y travestis, de quienes se recabaron 391 cuestionarios en la ciudad de Río de Janeiro y su región metropolitana, procedentes de diferentes clases sociales, niveles educacionales y configuraciones de identidad de género, que fueron contactados a través de redes sociales por parte de los entrevistadores. Con el fin de definir las identidades de género de quienes respondieron la encuesta, se usó un método original basado en autodefiniciones, que posteriormente fueron añadidas a 6 categorías para fines de análisis de datos. Este artículo discute las múltiples estrategias utilizadas, por parte de esta población trans en procesos de afirmación de género, para conseguir acceso al uso de hormonas reguladas y/o irregulares, así como procedimientos quirúrgicos.
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Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Somatotipos , Transexualidade/cirurgia , Travestilidade/cirurgia , Pessoas Transgênero/estatística & dados numéricos , Identidade de Gênero , Automedicação , Apoio Social , Fatores Socioeconômicos , Transexualidade/classificação , Brasil/epidemiologia , Inquéritos e Questionários , Autorrelato , Pessoas Transgênero/legislação & jurisprudência , Acessibilidade aos Serviços de Saúde , Hormônios/administração & dosagemRESUMO
Age and time-specific incidence rates are highly relevant to epidemiologists. Due to the mathematical relationship between incidence and prevalence, several methods have been developed to obtain incidence based on prevalence. The present study didactically describes a method to estimate age and time incidence, based on: repeated measurements of prevalence for an event; events related to the individual's age; and events with the characteristics of a chronic disease. The method was used to analyze literacy in the Brazilian population, using prevalence by age obtained from the National Household Sample Survey (PNAD) for 1981, 1985, 1989, 1992, 1995, and 2001, and allowed obtaining literacy incidence estimates for ages 5 to 20 years, for the years 1960 through 2001. The method adjusts incidence parameters for age and time with the help of a generalized linear model for categorical data and uses the EM algorithm to obtain non-observed data.
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Escolaridade , Inquéritos Epidemiológicos , Incidência , Modelos Estatísticos , Prevalência , Adolescente , Adulto , Distribuição por Idade , Brasil , Criança , Pré-Escolar , Métodos Epidemiológicos , Humanos , Pessoa de Meia-Idade , Características de Residência , Fatores de TempoRESUMO
Conhecer a incidência de algum evento por idade e tempo é sem dúvida um dos maiores interesses da epidemiologia. Devido à relação matemática que existe entre as medidas de incidência e prevalência, alguns métodos foram desenvolvidos com o objetivo de obter a incidência a partir da prevalência. Este estudo descreve, de forma tutorial, um método que fornece estimativas de incidências por idade e tempo desde que existam prevalências repetidas de um evento, que a ocorrência do mesmo esteja relacionada à idade do indivíduo e que este possua características de uma doença crônica. O estudo foi realizado para a alfabetização da população brasileira, utilizando as prevalências por idade obtidas na Pesquisa Nacional por Amostra de Domicílios (PNAD) 1981, 1985, 1989, 1992, 1995 e 2001, e permitiu recuperar as estimativas da incidência de alfabetização nas idades entre 5 e 20 anos entre os anos de 1960 a 2000. O método ajusta os parâmetros de incidência para idade e tempo com o auxílio de um modelo linear generalizado para dados categóricos e utiliza o algoritmo EM para obter os dados não observados.
Age and time-specific incidence rates are highly relevant to epidemiologists. Due to the mathematical relationship between incidence and prevalence, several methods have been developed to obtain incidence based on prevalence. The present study didactically describes a method to estimate age and time incidence, based on: repeated measurements of prevalence for an event; events related to the individual's age; and events with the characteristics of a chronic disease. The method was used to analyze literacy in the Brazilian population, using prevalence by age obtained from the National Household Sample Survey (PNAD) for 1981, 1985, 1989, 1992, 1995, and 2001, and allowed obtaining literacy incidence estimates for ages 5 to 20 years, for the years 1960 through 2001. The method adjusts incidence parameters for age and time with the help of a generalized linear model for categorical data and uses the EM algorithm to obtain non-observed data.
Assuntos
Adolescente , Adulto , Criança , Pré-Escolar , Humanos , Pessoa de Meia-Idade , Escolaridade , Inquéritos Epidemiológicos , Incidência , Modelos Estatísticos , Prevalência , Distribuição por Idade , Brasil , Métodos Epidemiológicos , Características de Residência , Fatores de TempoRESUMO
Introdução: faveolamento é um importante fator preditivo de mortalidade na fibrose pulmonar idiopática (FPI). O objetivo deste estudo foi comparar os achados clínicos e funcionais em pacientes com e sem faveolamento. Metodologia: foi realizado um estudo de corte transversal, em que foram avaliados 41 pacientes não tabagistas, portadores de FPI. Todos os pacientes responderam um questionário padronizado (incluindo avaliação de tempo de sintomas e dispnéia) e realizaram radiografia de tórax, tomografia computadorizada de alta resolução (TCAR), espirometria, oscilações forçadas, diluição com hélio e difusão com monóxido de carbono (DCO). Para uma análise mais específica das radiografias e dos exames de TCAR, os pacientes foram divididos em dois grupos: grupo A (presença de faveolamento) e grupo B (ausência de faveolamento). Resultados: dos 41 pacientes estudados, 26 eram mulheres e 15 eram homens, com média de idade de 70,8 anos. A radiografia convencional do tórax e a TCAR demonstraram o faveolamento em 26 e 34 casos, respectivamente. Houve razoável concordância entre os dois métodos na capacidade de mostrar esse tipo de anormalidade (φ=0,59; p<0,001). Foram observadas diferenças significativas na complacência dinâmica do sistema respiratório (Crs,dyn), DCO e capacidade pulmonartotal (CPT) entre os pacientes com e sem faveolamento, tanto na radiografia convencional do tórax quanto na TCAR. Para as variáveis clínicas, apenas a dispnéia associou-se ao grupo com faveolamento na radiografia de tórax. Conclusão: em portadores de FPI, os parâmetros funcionais refletem a intensidade do processo morfológico subjacente mais acuradamente queas manifestações clínicas da doença.