A scale-down mimic for mapping the process performance of centrifugation, depth and sterile filtration.

In the production of biopharmaceuticals disk-stack centrifugation is widely used as a harvest step for the removal of cells and cellular debris. Depth filters followed by sterile filters are often then employed to remove residual solids remaining in the centrate. Process development of centrifugation is usually conducted at pilot-scale so as to mimic the commercial scale equipment but this method requires large quantities of cell culture and significant levels of effort for successful characterization. A scale-down approach based upon the use of a shear device and a bench-top centrifuge has been extended in this work towards a preparative methodology that successfully predicts the performance of the continuous centrifuge and polishing filters. The use of this methodology allows the effects of cell culture conditions and large-scale centrifugal process parameters on subsequent filtration performance to be assessed at an early stage of process development where material availability is limited. Biotechnol. Bioeng. 2016;113: 1934-1941. © 2016 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.

A consensus rating method for small virus-retentive filters. II. Method evaluation.

Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter Task Force to develop a common nomenclature and a standardized test method for classifying and identifying viral-retentive filters. A test method based on bacteriophage PP7 retention was chosen based on developmental studies. The detailed final consensus filter method is published in the 2008 update of PDA Technical Report 41: Virus Filtration. Here, we evaluate the method and find it to be acceptable for testing scaled-down models of small virus-retentive filters from four manufacturers. Three consecutive lots of five filter types were tested (Pegasus SV4, Viresolve NFP, Planova 20N and 15N, Virosart CPV). Each passed the criteria specified in the test method (i.e., >4 log10 PP7 retention, >90% intravenous immunoglobulin passage, and passing integrity/installation testing) and was classified as PP7-LRV4.

A consensus rating method for small virus-retentive filters. I. Method development.

Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter Task Force to develop a common nomenclature and a standardized test method for classifying and identifying viral-retentive filters. One goal of the task force was to develop a test method for small virus-retentive filters. Because small virus-retentive filters present unique technical challenges, the test method development process was guided by laboratory studies to determine critical variables such as choice of bacteriophage challenge, choice of model protein, filtration operating parameters, target log10 reduction value, and filtration endpoint definition. Based on filtration, DLS, electrospray differential mobility analysis, and polymerase chain reaction studies, a final rating based on retention of bacteriophage PP7 was chosen by the PDA Virus Filter Task Force. The detailed final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration.

Manufacturing of Proteins and Antibodies: Chapter Downstream Processing Technologies.

Cell harvesting is the separation or retention of cells and cellular debris from the supernatant containing the target molecule Selection of harvest method strongly depends on the type of cells, mode of bioreactor operation, process scale, and characteristics of the product and cell culture fluid. Most traditional harvesting methods use some form of filtration, centrifugation, or a combination of both for cell separation and/or retention. Filtration methods include normal flow depth filtration and tangential flow microfiltration. The ability to scale down predictably the selected harvest method helps to ensure successful production and is critical for conducting small-scale characterization studies for confirming parameter targets and ranges. In this chapter we describe centrifugation and depth filtration harvesting methods, share strategies for harvest optimization, present recent developments in centrifugation scale-down models, and review alternative harvesting technologies.

An automated laboratory-scale methodology for the generation of sheared mammalian cell culture samples.

Continuous disk-stack centrifugation is typically used for the removal of cells and cellular debris from mammalian cell culture broths at manufacturing-scale. The use of scale-down methods to characterise disk-stack centrifugation performance enables substantial reductions in material requirements and allows a much wider design space to be tested than is currently possible at pilot-scale. The process of scaling down centrifugation has historically been challenging due to the difficulties in mimicking the Energy Dissipation Rates (EDRs) in typical machines. This paper describes an alternative and easy-to-assemble automated capillary-based methodology to generate levels of EDRs consistent with those found in a continuous disk-stack centrifuge. Variations in EDR were achieved through changes in capillary internal diameter and the flow rate of operation through the capillary. The EDRs found to match the levels of shear in the feed zone of a pilot-scale centrifuge using the experimental method developed in this paper (2.4×105 W/Kg) are consistent with those obtained through previously published computational fluid dynamic (CFD) studies (2.0×105 W/Kg). Furthermore, this methodology can be incorporated into existing scale-down methods to model the process performance of continuous disk-stack centrifuges. This was demonstrated through the characterisation of culture hold time, culture temperature and EDRs on centrate quality.

Atenção a saúde de imigrantes haitianos em Chapecó/SC

O presente artigo objetiva contextualizar a situação da imigração dos haitianos no país, focando na migração no estado de Santa Catarina, trazendo aspectos demográficos dessa população no território proposto. Métodos: através de estudo descritivo qualitativo, contando com a percepção dos autores mediante à temática do estudo. A obtenção de dados realizou-se por meio da pesquisa em capítulos de livros, artigos, resumos publicados em anais de eventos, monografias, dissertações e teses nos bancos de dados da Biblioteca Virtual da Saúde (BVS), Scholar Google, Scielo e PubMed, no período de 2010 à 2018. Resultados: A vinda de haitianos no país iniciou-se em 2010 com o terremoto no país. Desde então, 60 mil haitianos vivem no país, 60% deles residem na região sul. Em Chapecó/SC residem 2500 haitianos, o que hoje, é uma das cidades que mais recebem imigrantes, dando aos governantes um grande desafio para o pronto estabelecimento à eles, perpassando pelas oportunidades de emprego, como pelas assistenciais, dentre elas à saúde, que são garantias constitucionais. Considerações finais: pela escassez de dados, motivado pelo último Censo Demográfico, realizado em 2010, a análise se deu de modo empírico. Para melhor entendimento, é necessário novos estudos e levantamentos para que se possa realizar uma melhor assistência de maneira mais efetiva.

This article aims to contextualize the immigration situation of Haitians in the country, focusing on migration in the state of Santa Catarina, bringing demographic aspects of this population in the proposed territory. Methods: through a qualitative descriptive study, counting on the authors' perception through the thematic of the study. Data collection was carried out by means of research on chapters of books, articles, abstracts published in annals of events, monographs, dissertations and theses in the databases of the Virtual Health Library (VHL), Scholar Google, Scielo and PubMed, in the period from 2010 to 2018. Results: The arrival of Haitians in the country began in 2010 with the earthquake in the country. Since then, 60,000 Haitians live in the country, 60% of them reside in the southern region. Chapecó is home to 2,500 Haitians, which today is one of the cities that receive the most immigrants, giving the governors a great challenge to the ready establishment to them, passing through employment opportunities, as well as health care, which are constitutional guarantees . Final considerations: due to the scarcity of data, motivated by the last Demographic Census, conducted in 2010, the analysis was empirical. For better understanding, further studies and surveys are needed to enable better assistance to be performed more effectively.

Enfermeiro Professor: Limites e Possibilidades da Carreira Docente / Nursing Educator: Limitations and Possibilities of a Teaching Career

Objetivo: identificar os limites e as possibilidades de ser enfermeiro professor, em cursos de graduação de instituições públicas do sul do Brasil. Material e Métodos: estudo descritivo e exploratório com abordagem qualitativa, realizado com 16 enfermeiros professores de duas Instituições de Ensino Superior do Estado de Santa Catarina, Brasil. A coleta dos dados ocorreu entre os meses de fevereiro e junho de 2015, por meio de entrevistas semi-estruturadas. Os participantes foram selecionados por amostragem não probabilística, do tipo bola de neve. Para análise dos dados foi adotado a proposta operativa para dados qualitativos. As questões éticas foram respeitadas mediante parecer favorável do Comitê de Ética em Pesquisas. Resultados: os principais desafios da docência na enfermagem estão relacionados com a falta de preparo pedagógico do enfermeiro durante o seu processo de formação. Contudo, os enfermeiros professores buscam por novas metodologias de ensino, com destaque as problematizadoras, permanecendo em constante aprendizado na atuação docente. O aprimoramento da carreira docente desenvolve-se com o passar do tempo e pela experiência no exercício da docência, sendo determinantes os conhecimentos adquiridos também na prática de enfermagem. Conclusão: os enfermeiros professores preocupam-se com sua condição docente e buscam por novas metodologias pedagógicas, permanecendo em constante evolução e aprendizado nessa atuação. Os limites da prática do enfermeiro professor podem ser superados se o profissional admitir a sua condição de aprendiz, de ser inconcluso, disposto a assumir a construção do conhecimento em parceria com o acadêmico. (AU)

Objective: To identify the limitations and the possibilities of the teaching career in nursing undergraduate courses in public institutions from southern Brazil. Material and Methods: This was a descriptive, exploratory study with a qualitative approach, performed with 16 nurses of two Higher Education Institutions from Santa Catarina state, Brazil. The data were collected between the months of February and June using semi-structured interviews. Participants were selected by snowball non-probabilistics ampling. The operational proposal for qualitative data analysis was adopted, and all ethical issues were respected in accordance with the approval of the Research Ethics Committee. Results: The main challenges on teaching in nursing are related with the lack of pedagogical preparation of the nurse during nursing school. Nevertheless, nursing educators look for new teaching problem-solving based methodologies, and keep on constant learning on the act of teaching. The improvement on the teaching career develops with the pass of time and by the experience on the teaching exercise. The knowledge acquired with the practice of nursing itself is also a determinant factor. Conclusion: Nursing educators are concerned with their teaching condition and look for new pedagogical methodologies, remaining in constant evolution and learning in this role as a nurse professor. The limitations of the teaching practice can be surpassed if the professional admitted the ircondition of apprentice, of being unfinished, hence willing to assume knowledge construction in partnership with the students. (AU)

Ensino superior e associação brasileira de enfermagem: contribuições para o desenvolvimento e as memórias da profissão no Oeste de Santa Catarina / Higher education and the brazilian nursing association: contributions to the development and memories of the profession in the West of Santa Catarina

Este trabalho trata-se de uma pesquisa qualitativa, com delineamento histórico narrativo, desenvolvida no Oeste de Santa Catarina. As informações foram produzidas mediante entrevistas semiestruturadas, aplicadas entre os meses de maio de 2016 a maio de 2017, com quatro enfermeiras que participaram da trajetória da enfermagem na região. O objetivo desse estudo foi investigar em que medida a implantação de cursos superiores de enfermagem e a construção da Associação Brasileira de Enfermagem Seção Santa Catarina (ABEn-SC) Núcleo Chapecó contribuíram para o desenvolvimento da enfermagem no Oeste de Santa Catarina a partir do ponto de vista de protagonistas dessa história. Os resultados demonstram que a criação de cursos superiores de enfermagem e, consequente, incorporação do conhecimento científico à profissão, além da construção da ABEn-SC Núcleo Chapecó, se configuram como marcos históricos para a construção e desenvolvimento da enfermagem nessa região. Nota-se que o Oeste de Santa Catarina enfrentou obstáculos para o desenvolvimento da enfermagem, entretanto, as enfermeiras precursoras dessa história vêm construindo um cenário pautado no cuidado integral e qualificado de enfermagem, o que se deve, sobretudo, ao processo de qualificação da formação profissional e ao fortalecimento das entidades de classe.

Is bloodstream infection preventable among premature infants? A tale of two cities.

BACKGROUND: Bloodstream infection (BSI) is a significant cause of morbidity and death encountered in the NICU. The rates of BSIs vary significantly in NICUs across the nation. However, no attempt has been made to correlate this variation with specific infection-control practices and policies. We experienced a significant increase in BSIs in the NICU at the George Washington University Hospital and were seeking additional precautionary measures to reduce BSI rates. Our objective was to review policies and practices associated with lower infection rates nationally and to test their reproducibility in our unit. DESIGN AND METHODS: Data on BSI rates in 16 NICUs were reviewed. The BSI rate at Connecticut Children's Medical Center (CCMC) was the lowest among those reviewed. A team from George Washington University Hospital conducted a site visit to CCMC to examine their practices. Differences in the aseptic precautions used for intravenous line management were noted at CCMC, where a closed medication system is used. This system was applied at George Washington University Hospital starting January 1, 2001. Infection rates among low birth weight infants (<2500 g) at George Washington University Hospital in the period from January 1998 to December 2000 (group 1) were compared with those in the period from January 2001 to December 2003 (group 2). Comparisons between the 2 cohorts were made with Fisher's exact test, the Kruskal-Wallis test, and Student's t test. Multivariate analysis was used to control for differences in birth weight, gestational age, central line days, and ventilator days. Analyses were repeated for the subgroup of very low birth weight infants (<1500 g). RESULTS: A total of 536 inborn low birth weight infants were included in this retrospective study (group 1, N = 169 infants; group 2, N = 367). The incidence of sepsis decreased significantly from group 1 to group 2 (25.4% and 2.2%, respectively). The reduction of sepsis observed in association with the new practice was statistically significant after controlling for birth weight, central line days, and ventilator days in a multiple regression model (regression coefficient: 0.95 +/- 0.29). The odds ratio of reduction in sepsis after implementation of the new practice was 2.6 (95% confidence interval: 1.5-4.5). The central line-related BSI rate decreased from 15.17 infections per 1000 line days to 2.1 infections per 1000 line days. The study included 233 very low birth weight infants, ie, 90 in group 1 and 143 in group 2. The rate of BSIs decreased significantly from group 1 to group 2 (46.7% and 5.6%, respectively). The decrease in sepsis rate remained significant in a multiple regression model (regression coefficient: 1.42 +/- 0.35). The odds ratio of decreased sepsis in relation to the new policy application among the very low birth weight infants was 4.15 (95% confidence interval: 2.1-8.3). CONCLUSION: Applying the closed medication system was associated with reduced BSI rates in our unit. This protocol was easily reproducible in our environment and showed immediate results. Serious attempts to share data can potentially optimize outcomes and standardize policies and practices among NICUs.