Clean room technology,

Bibliography: p. 63-65.

Bioaerossóis na indústria farmacêutica

Este estudo teve como finalidade, testar uma barreira contra a contaminação microbiológica em placas de contato, utilizadas em monitoramento de salas limpas para fabricação de produtos farmacêuticos estéreis. Durante o ano de 2007, foram realizados testes de contato com a utilização da mencionada barreira, e os resultados foram comparados com dados dos anos de, 2004, 2005 e 2006, quando a barreira não foi utilizada. Os ambientes utilizados para os testes foram duas salas limpas de uma planta farmacêutica localizada no Rio de Janeiro. Nos mencionados ambientes é necessário o uso de uma vestimenta especial, de forma a evitar que partículas do corpo dos operadores, bactérias e fungos, migrem para a superfície externa do uniforme e coloquem em risco a esterilidade dos produtos. Sendo assim, foi proposta a colocação de uma camiseta diretamente sobre a pele do operador durante todo o ano de 2007 de forma a evitar ou reduzir a possibilidade de migração dessas partículas; e os resultados foram comparados com os anos de 2004, 2005 e 2006, quando a camiseta não foi usada. Os testes demonstraram que houve uma redução de cerca de 50% na ocorrência de placas contaminadas. Com relação ao número total de colônias formadas, a redução foi de 75% na comparação com os anos de 2004 e 2005 e de 50% com relação ao ano de 2006

Estudo para minimização do processo de fumigação empregado na limpeza e desinfecção de salas limpas em Bio-Manguinhos/ FIOCRUZ

As indústrias farmacêuticas que utilizam salas limpas, em seus processos produtivos, devem controlar ao máximo o nível de contaminantes microbiológicos, baseada na legislação RDC 210 que determina o cumprimento das diretrizes estabelecidas no Regulamento Técnico das Boas Práticas para a Fabricação de Medicamentos. Diante deste cenário, a proposta deste trabalho é avaliar o processo de fumigação com o reagente formaldeído, para a limpeza e desinfecção de salas limpas do Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Então, foram desenvolvidas as seguintes etapas: diagnóstico com as indústrias farmacêuticas para traçar um perfil quanto ao uso da fumigação; quantificação de resíduos gerados; avaliação da exposição dos operadores ao formaldeído que é cancerígeno e acompanhamento dos resultados do monitoramento ambiental do ar e de superfícies, inicialmente na sala limpa do SEFBC, cuja atividade principal é a formulação de vacinas bacterianas e biofármacos, após a implantação do espaçamento da fumigação. Os resultados discutidos na presente dissertação mostraram, que a maior parte das indústrias farmacêuticas, não realiza a desinfecção por intermédio da fumigação e que o resíduo gerado neste processo é o mais crítico. E, sobretudo, o monitoramento microbiológico do ar e de superfícies da sala limpa do SEFBC, a partir da metodologia adotada de espaçamento da fumigação, comprovou que não é necessário o emprego deste processo de forma rotineira, para garantir os níveis exigidos de limpeza e desinfecção da respectiva área

Caracterização molecular de bastonetes Gram positivos irregulares e actinomicetos aeróbios obtidos de espécimes clínicos, de ensaios de esterilidade e de áreas limpas

Os bastonetes Gram positivos irregulares (BGPIs) compõem um grupo de espécies bacterianas com ampla diversidade fenotípica e que podem estar presente no meio ambiente, na microbiota humana e de animais. A identificação acurada de BGPIs em nível de gênero e espécie empregando métodos bioquímicos convencionais é bastante limitada, sendo recomendado, portanto, o uso de técnicas moleculares. No presente estudo, foram identificadas amostras de BGPIs oriundas de espécimes clínicos de humanos, de produtos farmacêuticos e de áreas limpas através da análise de sequencias do gene 16S rRNA e de outros genes conservados (housekeeping genes). Os resultados obtidos pelo sequenciamento dos genes 16S rRNA e rpoB demonstraram C. striatum multi-resistente (MDR) como responsável por surto epidêmico em ambiente hospitalar da cidade do Rio de Janeiro. Quinze cepas de C. striatum foram isoladas em cultura pura a partir de secreção traqueal de pacientes adultos submetidos a procedimentos de entubação endotraqueal. A análise por eletroforese em gel de campo pulsado (PFGE) indicou a presença de quatro perfis moleculares, incluindo dois clones relacionados com cepas MDR (PFGE I e II). Os dados demonstram a predominância de PFGE I entre cepas MDR isoladas de unidades de terapia intensiva e enfermarias cirúrgicas. Uma potencial ligação causal entre a morte e a infecção por C. striatum MDR (PFGE tipos I e II) foi observada em cinco casos. Adicionalmente, acreditamos que este seja o primeiro estudo de identificação de espécies de Nocardia relacionadas com infecções humanas pela análise da sequencia multilocus (MLSA) no Brasil. Diferente dos dados observados na literatura (1970 a 2013) e obtidos pelos testes fenotípicos convencionais, a caracterização molecular de quatro lócus (gyrB-16S-secA1-hsp65) permitiu a identificação das espécies N. nova, N. cyriacigeorgica, N. asiatica e N. exalbida/gamkensis relacionadas com quadros de nocardiose em humanos. Cepas de N. nova isoladas de diferentes materiais clínicos de um único paciente apresentaram padrões de susceptibilidade antimicrobianos idênticos e dois perfis PFGE, indicando a possibilidade de quadros de co-infecção por N. nova em humanos. Em outra etapa da investigação, amostras de BGPIs obtidos de ambientes de salas limpas que não puderam ser identificadas por critérios convencionais foram submetidas a análise da sequência do gene 16S rRNA e caracterizadas 95,83% em nível de gênero e 35,42% em espécies. Para gêneros mais encontrados no estudo, foram analisados os genes rpoB e recA de dezessete cepas de Microbacterium e utilizado o MLSA para a identificação de sete cepas identificadas como Streptomyces. Os ensaios permitiram a identificação de três cepas de Microbacterium e de uma única amostra de Streptomyces ao nível de espécie. A análise da sequencia do gene rpoB também se mostrou eficaz na identificação de espécies de cepas de Corynebacterium. Finalmente, para as cepas ambientais pertencentes à classe Actinobacteria os dados morfológicos, bioquímicos e genotípicos permitiram documentar a cepa 3117BRRJ como representante de uma nova espécie do gênero Nocardioides, para o qual o nome Nocardioides brasiliensis sp. nov. e as cepas 3712BRRJ e 3371BRRJ como representante de um novo gênero e espécie para o qual o nome Guaraldella brasiliensis nov. foi proposto.

Occupational exposure to particles during hotel´s rooms cleaning

Background: The majority of studies investigated ambient particles, although in most industrialized countries people spend most of their time indoors and significant emissions of fine and ultrafine particles leading to human exposure are caused by various indoor tasks, including cleaning tasks. Objective: To characterize the occupational exposure to particles during cleaning of hotel's rooms. Methodology: Measurements of mass concentration and particle number concentration were performed before and during cleaning tasks in two rooms with different floor types (wood and carpet) with the equipment Lighthouse, model 3016 IAQ. Results: Considering mass concentration, particles with higher were responsable for higher leves of contamination, particularly PM5.0 and PM10.0. However, considering the particle number concentration, the smaller particle size obtained the higher values. Conclusion: It was observed higher number of particles of the smaller size in all tasks, which is associated with worse health effects. It was observed that the room with wood in the floor has lower values when compared to the room with carpet. The tasks with greater exposure were the 'vacuuming' and 'clean up powder'.

Passive solar systems for heating, daylighting and ventilation for rooms without an equator-facing facade

Spaces without northerly orientations have an impact on the ‘energy behaviour’ of a building. This paper outlines possible energy savings and better performance achieved by different zenithal solar passive strategies (skylights, roof monitors and clerestory roof windows) and element arrangements across the roof in zones of cold to temperate climates typical of the central and central-southern Argentina. Analyses were undertaken considering daylighting, thermal and ventilation performances of the different strategies. The results indicate that heating,ventilation and lighting loads in spaces without an equator-facing facade can be significantly reduced by implementing solar passive strategies. In the thermal aspect, the solar saving fraction reached for the different strategies were averaged 43.16% for clerestories, 41.4% for roof monitors and 38.86% for skylights for a glass area of 9% to the floor area. The results also indicate average illuminance levels above 500 lux for the different clerestory and monitor arrangements, uniformity ratios of 0.66–0.82 for the most distributed arrangements and day-lighting factors between 11.78 and 20.30% for clear sky conditions, depending on the strategy. In addition, minimum air changes rates of 4 were reached for the most extreme conditions.

Comparison of ultrafine particle release from hardcopy devices in emission test chambers and office rooms

The release of ultrafine particles (UFP) from laser printers and office equipment was analyzed using a particle counter (FMPS; Fast Mobility Particle Sizer) with a high time resolution, as well as the appropriate mathematical models. Measurements were carried out in a 1 m³ chamber, a 24 m³ chamber and an office. The time-dependent emission rates were calculated for these environments using a deconvolution model, after which the total amount of emitted particles was calculated. The total amounts of released particles were found to be independent of the environmental parameters and therefore, in principle, they were appropriate for the comparison of different printers. On the basis of the time-dependent emission rates, “initial burst” emitters and constant emitters could also be distinguished. In the case of an “initial burst” emitter, the comparison to other devices is generally affected by strong variations between individual measurements. When conducting exposure assessments for UFP in an office, the spatial distribution of the particles also had to be considered. In this work, the spatial distribution was predicted on a case by case basis, using CFD simulation.

Rooms on view : home and design exhibition

The expression of a narrative realized through a constructed interior environment provides a significant and engaging response that falls between the realms of design and theatre in which the space itself provides the role of actor.

Implementing the Clean Development Mechanism in Fiji : opportunities and barriers in the energy sector

The Clean Development Mechanism (CDM) has been praised for its ingenuity in mobilising finance to implement sustainable development practices in non-industrialised countries (known as Non-Annex 1 parties under the Kyoto Protocol). During the first commitment period of the Kyoto Protocol (2008-2012), a large number of clean development mechanism projects have been registered with the CDM board. In addition to the large number of registered CDM projects, there are significant numbers of proposed projects stalled in implementation due to the cumbersome and lengthy CDM approval process. Despite this regulatory criticism it is recognised that the role performed by the CDM is essential for achieving a significant reduction in global green house gas emissions. This is because the CDM funds sustainable development in countries that lack capacity to do so on their own. It is anticipated that some form of CDM instrument will continue post the 2012 timeframe and that reform of the mechanism will be focused around making the mechanism’s approval and implementation processes faster and more efficient.

A sustainable tourism development in Alacati, Turkey : (Re)invention of public space with clean energy

Although there is an increasing recognition of the impacts of climate change on communities, residents often resist changing their lifestyle to reduce the effects of the problem. By using a landscape architectural design medium, this paper argues that public space, when designed as an ecological system, has the capacity to create social and environmental change and to increase the quality of the human environment. At the same time, this ecological system can engage residents, enrich the local economy, and increase the social network. Through methods of design, research and case study analysis, an alternative master plan is proposed for a sustainable tourism development in Alacati, Turkey. Our master plan uses local geographical, economic and social information within a sustainable landscape architectural design scheme that addresses the key issues of ecology, employment, public space and community cohesion. A preliminary community empowerment model (CEM) is proposed to manage the designs. The designs address: the coexistence of local agricultural and sustainable energy generation; state of the art water management; and the functional and sustainable social and economic interrelationship of inhabitants, NGOs, and local government.

The Australian clean energy package and the law of the world trade organisation : an analysis of compliance issues

This thesis is a study of whether the Australian Clean Energy Package complies with the rules of the World Trade Organization. It examines the legal framework for the Australian carbon pricing mechanism and related arrangements, using World Trade Organization law as the framework for analysis. In doing so, this thesis deconstructs the Clean Energy Package by considering the legal properties of eligible emissions units, the assistance measures introduced by the Package and the liabilities created by the carbon pricing mechanism.

The impact of the clean development mechanism (CDM) on the cost price of wind power electricity : a China study

As a renewable energy source, wind power is playing an increasingly important role in China’s electricity supply. Meanwhile, China is also the world’s largest market for Clean Development Mechanism (CDM) wind power projects. Based on the data of 27 wind power projects of Inner Mongolia registered with the Executive Board of the United Nations (EB) in 2010, this paper constructs a financial model of Net Present Value (NPV) to analyze the cost of wind power electricity. A sensitivity analysis is then conducted to examine the impact of different variables with and without Certified Emission Reduction (CER) income brought about by the CDM. It is concluded that the CDM, along with static investment and annual wind electricity production, is one of the most significant factors in promoting the development of wind power in China. Additionally, wind power is envisaged as a practical proposition for competing with thermal power if the appropriate actions identified in the paper are made.

Subsidies of the Australian clean energy package

The Australian Clean Energy Package has been introduced to respond to the global challenge of climate change and reduce Australia’s greenhouse gas emissions. It includes legislation to establish an emissions trading scheme. In support of the entities that are liable under this Package, there are a number of assistance measures offered to alleviate the financial burden that the Package imposes. This paper considers whether these assistance measures are subsidies within the context of the law of the World Trade Organization. In order to do this, the rules of the Agreement on Subsidies and Countervailing Measures are examined. This examination enables an understanding of when a subsidy exists and in what circumstances those subsidies occasion the use of remedies under the law.