Cleaning validation of zidovudine: strategy applied to the process manufacture of antiretroviral medicines

A validação de limpeza é parte integrante do conjunto de normas que compõem as boas práticas de fabricação de medicamentos. Trata-se de sistemática utilizada para assegurar que os procedimentos de limpeza de equipamentos, efetivamente, removam os resíduos existentes até um nível de aceitação pré-determinado. Poucos trabalhos abordando a validação de limpeza estão disponíveis na literatura concernente à área. Neste, apresenta-se estratégia para validação do processo de limpeza utilizado na fabricação do medicamento zidovudina, produzido pelo LAFEPE® (Recife - PE, Brasil) largamente prescrito no tratamento da AIDS. Utilizou-se um método analítico por via espectrofotométrica e técnica de amostragem de superfícies por swab. O critério de aceitação da limpeza utilizado foi de 10 ppm de zidovudina no produto subseqüente (estavudina). Os resíduos de zidovudina encontrados nos equipamentos após a limpeza foram inferiores aos critérios de aceitação da limpeza, bem como do menor nível de concentração capaz de provocar ação farmacológica.The cleaning validation is integrant part of the laws of good manufacturing practices of medicines. Cleaning validation procedures are carried out in order to assure that residues are within acceptable limits after the cleaning process. Very little has been published regarding practices within the pharmaceutical industry. This work presents a strategy for cleaning validation of the process equipments of the medicine zidovudine produced by LAFEPE (Recife - PE, Brazil) utilized in AIDS treatment. An analytical method by spectrofotometry and samples surfaces by swab was utilized. The acceptance criteria from the cleaning utilized was 10 ppm of zidovudine in the subsequent product (stavudine). The residues of zidovudine found in the equipment after cleaning were lower that limits established as well as to the smaller level of concentration capable of producing pharmacological effects

Piglet colibacillosis diagnosis based on multiplex polymerase chain reaction and immunohistochemistry of paraffin-embedded tissues

Enterotoxigenic Escherichia coli (ETEC) causes diarrhea in pigs, referred to as colibacillosis. The aim of this study was to optimize multiplex polymerase chain reaction (PCR) and immunohistochemistry (IHC) analyses of paraffin-embedded material to detect pathogenic E. coli strains causing colibacillosis in pigs. Multiplex PCR was optimized for fimbriae (F18, F4, F6, F5, and F41) and toxins (types A and B heat-stable toxins [STaP and STb], heat-labile toxin [LT], and type 2 Shiga toxin [STx2e]), and IHC was optimized for an anti-E. coli polyclonal antibody. Samples (132) from pigs received between 2006 and 2014 with clinical and histopathological diagnoses of colibacillosis were analyzed. E. coli was detected by IHC in 78.7%, and at least one virulence factor gene was detected in 71.2%. Pathogenic strains of ETEC with at least one fimbria and one toxin were detected in 40% of the samples in multiplex PCR. The most frequent virulence types were F18-STaP (7.5%), F18-STaP-STb (5.7%), and F4-STaP (3.8%). A statistically significant association was noted between virulence factors F4, F18, STaP, and STb and positive immunostaining results. Colibacillosis diagnosis through multiplex PCR and IHC of paraffin-embedded tissues is a practical approach, as samples can be fixed and stored for long periods before analysis

Outbreak of parvoviral myocarditis in puppies in Brazil

We describe the epidemiological, clinical, pathological and immunohistochemical aspects of parvoviral myocarditis outbreak in puppies. The outbreak occurred in a kennel located in Parnamirim, Rio Grande do Norte, Northeastern of Brazil. In a litter of nine pups, one was stillbirth and six died between 35-57 days of age after cardiopulmonary clinical signs with evolution of 10 minutes to three days. Of the six puppies that died, two were sent for necropsy. On gross examination, both animals had discreet pericardial effusion, markedly distended heart, diffuse pallor in epicardial and myocardial surfaces and dilation of the left ventricular cavity. The lungs were observed multifocal reddish areas in the pleural surface and at cutting flowed foamed and slightly red liquid. The liver was diffusely increased in size, with lobular standard accentuation and pale areas interspersed with dark areas wich deepened in the parenchyma. Microscopically observed linfohistiocítica myocarditis, necrotizing, associated with interstitial fibrosis and basophilic intranuclear viral inclusions corpuscles in cardiomyocytes. In the lungs there were edema and interstitial pneumonia and in the liver was noted centrilobular to mediozonal degeneration and necrosis associated with congestion and hemorrhage. The diagnosis was confirmed by immunohistochemistry. The parvoviral myocarditis can occasionally occur in puppies of bitches that have not been effectively vaccinated. This clinical form of the disease characterized by cardiorespiratory changes and hyperacute or acute death of the affected animals

Outbreak of parvoviral myocarditis in puppies in Brazil

We describe the epidemiological, clinical, pathological and immunohistochemical aspects of parvoviral myocarditis outbreak in puppies. The outbreak occurred in a kennel located in Parnamirim, Rio Grande do Norte, Northeastern of Brazil. In a litter of nine pups, one was stillbirth and six died between 35-57 days of age after cardiopulmonary clinical signs with evolution of 10 minutes to three days. Of the six puppies that died, two were sent for necropsy. On gross examination, both animals had discreet pericardial effusion, markedly distended heart, diffuse pallor in epicardial and myocardial surfaces and dilation of the left ventricular cavity. The lungs were observed multifocal reddish areas in the pleural surface and at cutting flowed foamed and slightly red liquid. The liver was diffusely increased in size, with lobular standard accentuation and pale areas interspersed with dark areas wich deepened in the parenchyma. Microscopically observed linfohistiocítica myocarditis, necrotizing, associated with interstitial fibrosis and basophilic intranuclear viral inclusions corpuscles in cardiomyocytes. In the lungs there were edema and interstitial pneumonia and in the liver was noted centrilobular to mediozonal degeneration and necrosis associated with congestion and hemorrhage. The diagnosis was confirmed by immunohistochemistry. The parvoviral myocarditis can occasionally occur in puppies of bitches that have not been effectively vaccinated. This clinical form of the disease characterized by cardiorespiratory changes and hyperacute or acute death of the affected animals

Rectal stenosis in pigs associated with Salmonella Typhimurium and porcine circovirus type 2 (PCV2) infection

Rectal stricture is an acquired annular fibrous constriction of the rectum that results from a variety of chronic necrotizing enteric diseases. In pigs, it is in most cases a sequel of Salmonella infection. Porcine circovirus type 2 (PCV2) is a known pathogen causing immunosuppression in pigs worldwide. PCV2 infected pigs may be predisposed to salmonellosis. In this report, rectal stenosis was observed in 160 pigs from a herd that experienced an outbreak of enteric salmonellosis over a 4-month period. Distension of the abdominal wall and diarrhea were the main clinical signs observed. Five animals were analyzed showing annular cicatrization of the rectal wall 5.0-7.0 cm anterior to the anorectal junction and Salmonella-positive immunostaining in the large intestine. Salmonella Typhimurium was isolated from fragments of the large intestine. Porcine circovirus type 2 antigen was observed in the mesenteric lymph-node in 4 pigs and in the large intestine in 3 pigs

Professores e Alunos: o engendramento da violência da escola

The school violence engendering is partially analyzed, considering the violence production in the school environment. This is a bibliographic research with quantitative and qualitative approach. Sources: 77 theses and 15 dissertations carried out in Brazil (2007 to 2012). Data collection and organization: Content Analysis. Main reference: Bernard Charlot and Pierre Bourdieu. Results: the sources showed that Brazilian teachers participate effectively in the school violence engendering, contributing to violence production in the school environment. The students are the main victims. The teacher is less affected by physical and verbal violence. The symbolic power is the most perpetrated by the teacher against the student. The school also plays a major role in it.Analisa-se o engendramento de uma face da violência da escola, tendo em vista a produção da violência em espaço escolar. Pesquisa bibliográfica quanti-qualitativa. Fontes: 77 dissertações e 15 teses produzidas no Brasil (2007 a 2012). Coleta e organização dos dados: Análise de Conteúdo. Fundamentação base: Bernard Charlot e Pierre Bourdieu. Resultados: as fontes apontaram que professores brasileiros são protagonistas na constituição da violência da escola, contribuindo para a produção da violência em espaço escolar. Os alunos são as principais vítimas dessa violência. O professor sofre menos violência física e verbal do que o aluno. A violência simbólica é a mais usada pelo professor contra o aluno. A escola também usa desse expediente

NEOTROPICAL ALIEN MAMMALS: a data set of occurrence and abundance of alien mammals in the Neotropics

Biological invasion is one of the main threats to native biodiversity. For a species to become invasive, it must be voluntarily or involuntarily introduced by humans into a nonnative habitat. Mammals were among first taxa to be introduced worldwide for game, meat, and labor, yet the number of species introduced in the Neotropics remains unknown. In this data set, we make available occurrence and abundance data on mammal species that (1) transposed a geographical barrier and (2) were voluntarily or involuntarily introduced by humans into the Neotropics. Our data set is composed of 73,738 historical and current georeferenced records on alien mammal species of which around 96% correspond to occurrence data on 77 species belonging to eight orders and 26 families. Data cover 26 continental countries in the Neotropics, ranging from Mexico and its frontier regions (southern Florida and coastal-central Florida in the southeast United States) to Argentina, Paraguay, Chile, and Uruguay, and the 13 countries of Caribbean islands. Our data set also includes neotropical species (e.g., Callithrix sp., Myocastor coypus, Nasua nasua) considered alien in particular areas of Neotropics. The most numerous species in terms of records are from Bos sp. (n = 37,782), Sus scrofa (n = 6,730), and Canis familiaris (n = 10,084); 17 species were represented by only one record (e.g., Syncerus caffer, Cervus timorensis, Cervus unicolor, Canis latrans). Primates have the highest number of species in the data set (n = 20 species), partly because of uncertainties regarding taxonomic identification of the genera Callithrix, which includes the species Callithrix aurita, Callithrix flaviceps, Callithrix geoffroyi, Callithrix jacchus, Callithrix kuhlii, Callithrix penicillata, and their hybrids. This unique data set will be a valuable source of information on invasion risk assessments, biodiversity redistribution and conservation-related research. There are no copyright restrictions. Please cite this data paper when using the data in publications. We also request that researchers and teachers inform us on how they are using the data