Validação da eficácia dos procedimentos de limpeza, no equipamento de fabrico e embalagem, na indústria farmacêutica

Na indústria farmacêutica, a limpeza dos equipamentos e superfícies é muito importante no processo de fabrico/embalagem dos produtos farmacêuticos. Possíveis resíduos contaminantes devem ser removidos dos equipamentos e das superfícies envolvidas no processo. De acordo com as Boas Práticas de Fabrico (GMP), os procedimentos de limpeza e os métodos analíticos usados para determinar as quantidades de resíduos devem ser validados. O método analítico combinado com o método de amostragem utilizado na colheita de amostras deve ser sujeito a um ensaio de “recovery”. Neste trabalho apresenta-se uma estratégia inovadora para a validação de limpeza de formas farmacêuticas semi-sólidas. Propõe-se o uso de um método de amostragem que consiste na colheita direta de amostra após o seu fabrico, sendo a análise de resíduos feita directamente nesta amostra. Os produtos escolhidos para a avaliação da estratégia foram dois medicamentos dermatológicos, apresentados na forma de pomada e produzidos numa unidade de fabrico de vários produtos, pela Schering Plough Farma/ Merck Sharp & Dohme (Cacém, Portugal). Como métodos analíticos para a quantificação dos resíduos, utilizaram-se métodos validados por via espectrofotométrica (HPLC), usados na análise do produto acabado. A validação de limpeza foi avaliada através da análise de uma quantidade conhecida de pomada (produto B (*)), usando o método de análise da pomada fabricada anteriormente (produto A (*)), de modo a verificar-se a existência ou não de agente de limpeza e substâncias ativas deixadas após a limpeza do produto A, e vice-versa. As concentrações residuais das substâncias ativas e do agente de limpeza encontradas após a limpeza foram nulas, ou seja, inferiores ao limite de deteção (LOD), sendo que o critério de aceitação da limpeza utilizado foi de 6,4 x 10-4 mg/g para a substância ativa 1 (*); 1,0 x 10-2 mg/g para a substância ativa 2 (*); 1,0 x 10-3 mg/g para a substância ativa 3 (*) e de 10 ppm para o agente de limpeza. No ensaio de “recovery”, obtiveram-se resultados acima de 70% para todas as substâncias ativas e para o agente de limpeza nas duas pomadas. Antes de se proceder a este ensaio de “recovery”, houve a necessidade de ajustar as condições cromatográficas dos métodos analíticos de ambos os produtos e do agente de limpeza, por forma a obter-se valores da conformidade do sistema (fator de tailling e de resolução) de acordo com as especificações. A precisão dos resultados, reportada como desvio padrão relativo (RSD), deu abaixo de 2,0%, excepto nos ensaios que envolvem a substância ativa 3, cuja especificação é inferior a 10,0%. Os resultados obtidos demonstraram que os procedimentos de limpeza usados na unidade de fabrico em causa são eficazes, eliminando assim a existência de contaminação cruzada.

Biodiesel production from waste frying oils over lime catalysts

Biodiesel production from semi-refined oils (SRO) and waste frying oils (WFO) was studied using commercial CaO as heterogeneous catalyst. The methanolysis tests were carried out in mild reaction conditions (62 A degrees C, atmospheric pressure). With such conditions, SRO (soybean and rapeseed) allowed to produce a biodiesel containing 97-98 % of methyl esters (FAME), whereas WFO only provided 86-87 % of FAME. The lower FAME yield for WFO oil is ascribable to the partial neutralization of the catalyst by free fatty acids. Also, soaps formation from the WFO oil reduced the weight yield of the oil phase (containing FAME) obtained and increased the MONG content of the glycerin phase. The catalysts stability tests showed high stability even when WFO oil was processed. Catalytic tests performed with blends of WFO/semi-refined oils showed blending as a good strategy to process low value raw oils with minor decay of the catalyst performance. Both WFO and semi-refined oils showed S-shape kinetics curves thus discarding significant differences of the reaction mechanisms.

O desenvolvimento profissional docente: a função supervisiva do coordenador de ano do 1º ciclo

Dissertação apresentada à Escola Superior de Educação de Lisboa para obtenção de grau de mestre em Ciências da Educação, especialidade de Supervisão em Educação

Towards an Academic Social Network for Bologna Process

The Bologna Process aimed to build a European Higher Education Area promoting student's mobility. The adoption of Bologna Declaration directives requires a self management distributed approach to deal with student's mobility, allowing frequent updates in institutions rules or legislation. This paper suggests a computational system architecture, which follows a social network design. A set of structured annotations is proposed in order to organize the user's information. For instance, when the user is a student its annotations are organized into an academic record. The academic record data is used to discover interests, namely mobility interests, among students that belongs the academic network. These ideas have been applied into a demonstrator that includes a mobility simulator to compare and show the student's academic evolution.

A student personal system for Bologna process mobility

The Bologna Process aimed to build a European Higher Education Area with the objective of promoting students mobility. The adoption of Bologna Declaration directives requires a decentralized approach that accelerates student's mobility, based on frequently updated legislation. This paper proposes a student personal system to manage student's academic information. This system is supported by a flexible model that integrates, for instance, knowledge about the student attended courses or about a course that the student wishes to apply. Essentially, this model holds a (i) Student's Academic Record with skills acquired in academic course units, professional experience or training and an (ii) Individual Studies Plan, which places the student in a particular (iii) Course Plan setting the curricular structure that the student wishes to apply.

Distributed process execution in collaborative networks

Processes are a central entity in enterprise collaboration. Collaborative processes need to be executed and coordinated in a distributed Computational platform where computers are connected through heterogeneous networks and systems. Life cycle management of such collaborative processes requires a framework able to handle their diversity based on different computational and communication requirements. This paper proposes a rational for such framework, points out key requirements and proposes it strategy for a supporting technological infrastructure. Beyond the portability of collaborative process definitions among different technological bindings, a framework to handle different life cycle phases of those definitions is presented and discussed. (c) 2007 Elsevier Ltd. All rights reserved.

Diffuse liver disease classification from ultrasound surface characterization, clinical and laboratorial data

In this work liver contour is semi-automatically segmented and quantified in order to help the identification and diagnosis of diffuse liver disease. The features extracted from the liver contour are jointly used with clinical and laboratorial data in the staging process. The classification results of a support vector machine, a Bayesian and a k-nearest neighbor classifier are compared. A population of 88 patients at five different stages of diffuse liver disease and a leave-one-out cross-validation strategy are used in the classification process. The best results are obtained using the k-nearest neighbor classifier, with an overall accuracy of 80.68%. The good performance of the proposed method shows a reliable indicator that can improve the information in the staging of diffuse liver disease.

Representações sobre a creche dos pais de crianças que frequentam a creche e dos pais que optaram por outro cuidado

Dissertação apresentada na Escola Superior de Educação de Lisboa, para obtenção do grau de Mestre em Ciências da Educação - Especialidade Intervenção Precoce

Avaliação de desempenho docente: efeitos no desenvolvimento profissional.

Dissertação apresentada à Escola Superior de Educação de Lisboa para obtenção de grau de mestre em Ciências da Educação - Especialização Supervisão em Educação

Percursos de vida profissional: da formação inicial à entrada na carreira

Dissertação apresentada à Escola Superior de Educação de Lisboa para a obtenção do Grau de Mestre em Ciências da Educação - especialidade Supervisão em Educação

Este outro que eu sou agora: impacto da surdez adquirida no adulto jovem

Dissertação apresentada à Escola Superior de Educação de Lisboa para obtenção de grau de mestre em Ciências da Educação - Especialidade Educação Especial

Validação de um método de cromatografia líquida de alta resolução (HPLC) para doseamento da vitamina D em géneros alimentícios: aplicação do método em diferentes matrizes alimentares

Trabalho Final de Mestrado para obtenção do grau de Mestre em Engenharia Química e Biológica

Characterization of airborne particles generated from metal active gas welding process

This study is focused on the characterization of particles emitted in the metal active gas welding of carbon steel using mixture of Ar + CO2, and intends to analyze which are the main process parameters that influence the emission itself. It was found that the amount of emitted particles (measured by particle number and alveolar deposited surface area) are clearly dependent on the distance to the welding front and also on the main welding parameters, namely the current intensity and heat input in the welding process. The emission of airborne fine particles seems to increase with the current intensity as fume-formation rate does. When comparing the tested gas mixtures, higher emissions are observed for more oxidant mixtures, that is, mixtures with higher CO2 content, which result in higher arc stability. These mixtures originate higher concentrations of fine particles (as measured by number of particles by cm 3 of air) and higher values of alveolar deposited surface area of particles, thus resulting in a more severe worker's exposure.

How new online communication tools and the availability of content influence the audiences and the creative process

We live in a changing world. At an impressive speed, every day new technological resources appear. We increasingly use the Internet to obtain and share information, and new online communication tools are emerging. Each of them encompasses new potential and creates new audiences. In recent years, we witnessed the emergence of Facebook, Twitter, YouTube and other media platforms. They have provided us with an even greater interactivity between sender and receiver, as well as generated a new sense of community. At the same time we also see the availability of content like it never happened before. We are increasingly sharing texts, videos, photos, etc. This poster intends to explore the potential of using these new online communication tools in the cultural sphere to create new audiences, to develop of a new kind of community, to provide information as well as different ways of building organizations’ memory. The transience of performing arts is accompanied by the need to counter that transience by means of documentation. This desire to ‘save’ events reaches its expression with the information archive of the different production moments as well as the opportunity to record the event and present it through, for instance, digital platforms. In this poster we intend to answer the following questions: which online communication tools are being used to engage audiences in the cultural sphere (specifically between theater companies in Lisbon)? Is there a new relationship with the public? Are online communication tools creating a new kind of community? What changes are these tools introducing in the creative process? In what way the availability of content and its archive contribute to the organization memory? Among several references, we will approach the two-way communication model that James E. Grunig & Todd T. Hunt (1984) already presented and the concept of mass self-communication of Manuel Castells (2010). Castells also tells us that we have moved from traditional media to a system of communication networks. For Scott Kirsner (2010), we have entered an era of digital creativity, where artists have the tools to do what they imagined and the public no longer wants to just consume cultural goods, but instead to have a voice and participate. The creativity process is now depending on the public choice as they wander through the screen. It is the receiver who owns an object which can be exchanged. Virtual reality has encouraged the receiver to abandon its position of passive observer and to become a participant agent, which implies a challenge to organizations: inventing new forms of interfaces. Therefore, we intend to find new and effective online tools that can be used by cultural organizations; the best way to manage them; to show how organizations can create a community with the public and how the availability of online content and its archive can contribute to the organizations’ memory.