Analogias entre a serie iso 14000, os instrumentos legais brasileiros de controle ambiental e o metodo Zopp

Orientador: Rozely Ferreira dos SantosDissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Engenharia CivilResumo: Este trabalho consiste na análise dos instrumentos legais reguladores existentes no país e a sua comparação com os requisitos das normas da série ISO 14000 voltadas a aspectos de gerência de processos, mais notadamente as normas que especificamsistemas de gestão ambiental. São levantadosos requisitos legais existentes na esfera federal e do Estado de São Paulo, analisando-se criticamente o conteúdo e aplicabilidade destes instrumentos no ambiente empresarial privado. Tendências sobre futuros documentos legais também são resumidamente apresentadas. Em seguida, apresenta-se resumidamente a série ISO 14000, enfatizando a implementação de um sistema de gestão ambiental (SGA) baseado na norma ISO 14001. Outras normas da série voltadas a auditoria e avaliação de desempenho ambiental - ferramentas auxiliares na implementação de um SGA -são também analisadas de uma maneira comentada, detalhando-se o conteúdo e aplicabilidade destes documentos no mesmo ambiente citado. Ainda sobre auditoria ambiental, também se analisa criticamente os documentos legais brasileiros sobre este tema, que são em seguida comparados com os conceitos e processos de auditoria de sistema de gestão ambiental definidos pelas normas ISO que tratam deste assunto e por diferentes critérios de auditoria de SGAs, destacando-se o critério brasileiro. A seguir, utilizando-se o método Zopp de planejamento orientado a objetivos, devidamente adaptado, descreve-se um processo de implementação dos aspectos da série ISO 14000 mais direcionados à questão das interfaces com os instrumentos reguladores, discutindo-se também as vantagens e desvantagens da adaptação desta metodologia, que se mostra aplicável a este estudo... Observação: O resumo, na íntegra, poderá ser visualizado no texto completo da tese digitalAbstract: This work is based on the analysis of the existing Brazilian environrnental legal instruments and the relations with requirements defined on ISO 14000 standards related to process management, focused on the standards that specify environmental management systems. Existing legal requirements (country and São Paulo state levels) are identified and critically reviewed in terms of contents and applicability for private companies. Future trends on environmental regulations are also presented. The ISO 14000 series is synthetically presented, focusing the environrnental anagement system (EMS) implementation based on ISO 14001 standard. Other ISO related standards, regarding environmental audits and environmental performance evaluation - complementary tools for EMS implementation-are also analyzed more critically,detailing the contents and applicability of these standards for the same environment. Environmental Audits are critically discussed in the universe of Brazilian legal documents, that are compared with concepts and processes of environmental management systems audits as defined by ISO related standards, and driven by different EMS audit criteria, focusing the Brazilian one. Following the study, an implementation process of ISO 14000 aspects is presented focusing the interfaces with legal requirements, using the Zopp (planning oriented to objectives), properly adapted, also analyzing benefits and disadvantages of this methodology... Note: The complete abstract is available with the full electronic digital thesis or dissertationsMestradoSaneamentoMestre em Engenharia Civi

Implementation of Coating Care in Brazil for pollution and accident prevention on coatings sector

Orientador: Waldir Antonio BizzoTese (doutorado) - Universidade Estadual de Campinas, Faculdade de Engenharia MecânicaResumo: O conceito de preservação e sustentabilidade ambiental tem evoluído e vem sendo disseminado em diversos setores da sociedade, incluindo o mundo corporativo das empresas e negócios. Um dos resultados é a utilização de programas voluntários de boas práticas de gestão, aplicados por entidades setoriais da economia. No setor de tintas, o programa Coatings Care tem sido aplicado no Brasil. A análise das estratégias e alternativas de implementação deste programa no Brasil, bem como a proposição e execução de uma sequência metodológica inédita para este tipo de aplicação, englobando as etapas planejamento e implementação e que pode ser aplicada a qualquer programa voluntário de gestão é aqui apresentada. Foram utilizadas na etapa de planejamento as metodologias das Cinco Forças de Porter, SWOT e Cadeia de Valor de Porter, todas adaptadas e modificadas em função de serem aplicadas, nesta tese, em um problema para o qual não foram desenvolvidas originalmente. Para a implementação, foram adotadas as metodologias PMBOK e PSII, cujo conjunto se mostrou uma alternativa viável para situações similares à analisada. Os resultados obtidos em relação à participação das empresas no programa indicam a evolução das práticas de gestão ambiental e ocupacional no setor de tintas, bem como o crescente nível de maturidade apresentado pelo programa desde 2004. A análise dos resultados brasileiros, comparados aos obtidos em outros países, permite identificar as ações a serem tomadas para a melhoria e evolução do programa.Abstract: The concept of environmental protection and sustainability is present in several segments of the society, including the corporate environment. One of the results is the adoption of voluntary programs related to good management practices, sponsored by several entities representing business sectors. On coatings sector, Coatings Care program was adopted in Brazil. The analysis of strategies and alternatives for implementation in Brasil, as well as the proposition and deployment of a unique methodological sequence for planning and program implementation that can be applied to the implementation of any other voluntary program is presented on this study. The methodologies of Porter's Five Forces, SWOT and Porter's Chain of Value, all adapted and modified according to this purpose, were used. For implementation, PMBOK and PSII methodologies were applied. This set of tools resulted in a viable alternative for the case evaluated, as well as for similar situations. The results related to the level of implementation indicate evolution on the environmental, health and safety practices on coatings sector, as well as the increase, since 2004, of the program maturity. The analysis of Brazilian results, compared to the results obtained in other countries, drives the identification of actions for program improvement and evolution.DoutoradoTermica e FluidosDoutor em Engenharia Mecânic

High-throughput manufacturing of size-tuned liposomes by a new microfluidics method using enhanced statistical tools for characterization

Microfluidics has recently emerged as a new method of manufacturing liposomes, which allows for reproducible mixing in miliseconds on the nanoliter scale. Here we investigate microfluidics-based manufacturing of liposomes. The aim of these studies was to assess the parameters in a microfluidic process by varying the total flow rate (TFR) and the flow rate ratio (FRR) of the solvent and aqueous phases. Design of experiment and multivariate data analysis were used for increased process understanding and development of predictive and correlative models. High FRR lead to the bottom-up synthesis of liposomes, with a strong correlation with vesicle size, demonstrating the ability to in-process control liposomes size; the resulting liposome size correlated with the FRR in the microfluidics process, with liposomes of 50 nm being reproducibly manufactured. Furthermore, we demonstrate the potential of a high throughput manufacturing of liposomes using microfluidics with a four-fold increase in the volumetric flow rate, maintaining liposome characteristics. The efficacy of these liposomes was demonstrated in transfection studies and was modelled using predictive modeling. Mathematical modelling identified FRR as the key variable in the microfluidic process, with the highest impact on liposome size, polydispersity and transfection efficiency. This study demonstrates microfluidics as a robust and high-throughput method for the scalable and highly reproducible manufacture of size-controlled liposomes. Furthermore, the application of statistically based process control increases understanding and allows for the generation of a design-space for controlled particle characteristics

Surface Miscibility Of Epc/dotap/dope In Binary And Ternary Mixed Monolayers

Surface pressure (π)-molecular area (A) curves were used to characterize the packing of pseudo-ternary mixed Langmuir monolayers of egg phosphatidylcholine (EPC), 1,2-dioleoyl-3-trimethylammonium propane (DOTAP) and l-α-dioleoyl phosphatidylethanolamine (DOPE). This pseudo-ternary mixture EPC/DOPE/DOTAP has been successfully employed in liposome formulations designed for DNA non-viral vectors. Pseudo-binary mixtures were also studied as a control. Miscibility behavior was inferred from π-A curves applying the additivity rule by calculating the excess free energy of mixture (ΔG Exc). The interaction between the lipids was also deduced from the surface compressional modulus (C s -1). The deviation from ideality shows dependence on the lipid polar head type and monolayer composition. For lower DOPE concentrations, the forces are predominantly attractive. However, if the monolayer is DOPE rich, the DOTAP presence disturbs the PE-PE intermolecular interaction and the net interaction is then repulsive. The ternary monolayer EPC/DOPE/DOTAP presented itself in two configurations, modulated by the DOPE content, in a similar behavior to the DOPE/DOTAP monolayers. These results contribute to the understanding of the lipid interactions and packing in self-assembled systems associated with the in vitro and in vivo stability of liposomes. © 2010 Elsevier B.V.832260269de Lima, M.C.P., Simoes, S., Pires, P., Faneca, H., Duzgunes, N., Cationic lipid-DNA complexes in gene delivery: from biophysics to biological applications (2001) Adv. Drug Deliv. Rev., 47, pp. 277-294Felgner, P.L., Gadek, T.R., Holm, M., Roman, R., Chan, H.W., Wenz, M., Northrop, J.P., Danielsen, M., Lipofection-a highly efficient, lipid-mediated DNA-transfection procedure (1987) Proc. Natl. Acad. Sci. 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Surface miscibility of EPC/DOTAP/DOPE in binary and ternary mixed monolayers

Surface pressure (π)-molecular area (A) curves were used to characterize the packing of pseudo-ternary mixed Langmuir monolayers of egg phosphatidylcholine (EPC), 1,2-dioleoyl-3-trimethylammonium propane (DOTAP) and L-α-dioleoyl phosphatidylethanolamine (DOPE). This pseudo-ternary mixture EPC/DOPE/DOTAP has been successfully employed in liposome formulations designed for DNA non-viral vectors. Pseudo-binary mixtures were also studied as a control. Miscibility behavior was inferred from π-A curves applying the additivity rule by calculating the excess free energy of mixture (ΔG(Exc)). The interaction between the lipids was also deduced from the surface compressional modulus (C(s)(-1)). The deviation from ideality shows dependence on the lipid polar head type and monolayer composition. For lower DOPE concentrations, the forces are predominantly attractive. However, if the monolayer is DOPE rich, the DOTAP presence disturbs the PE-PE intermolecular interaction and the net interaction is then repulsive. The ternary monolayer EPC/DOPE/DOTAP presented itself in two configurations, modulated by the DOPE content, in a similar behavior to the DOPE/DOTAP monolayers. These results contribute to the understanding of the lipid interactions and packing in self-assembled systems associated with the in vitro and in vivo stability of liposomes.832260269COORDENAÇÃO DE APERFEIÇOAMENTO DE PESSOAL DE NÍVEL SUPERIOR – CAPESFUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO – FAPESPsem informaçã

Effects of extrusion, lipid concentration and purity on physico-chemical and biological properties of cationic liposomes for gene vaccine applications

We developed cationic liposomes containing DNA through a conventional process involving steps of (i) preformation of liposomes, (ii) extrusion, (iii) drying and rehydration and (iv) DNA complexation. Owing to its high prophylactic potentiality against tuberculosis, which had already been demonstrated in preclinical assays, we introduced modifications into the conventional process towards getting a simpler and more economical process for further scale-up. Elimination of the extrusion step, increasing the lipid concentration (from 16 to 64 mM) of the preformed liposomes and using good manufacturing practice bulk lipids (96–98% purity) instead of analytical grade purity lipids (99.9–100%) were the modifications studied. The differences in the physico-chemical properties, such as average diameter, zeta potential, melting point and morphology of the liposomes prepared through the modified process, were not as significant for the biological properties, such as DNA loading on the cationic liposomes, and effective immune response in mice after immunisation as the control liposomes prepared through the conventional process. Beneficially, the modified process increased productivity by 22% and reduced the cost of raw material by 75%298759769FUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO - FAPESPsem informaçã

Effects Of Extrusion, Lipid Concentration And Purity On Physico-chemical And Biological Properties Of Cationic Liposomes For Gene Vaccine Applications.

We developed cationic liposomes containing DNA through a conventional process involving steps of (i) preformation of liposomes, (ii) extrusion, (iii) drying and rehydration and (iv) DNA complexation. Owing to its high prophylactic potentiality against tuberculosis, which had already been demonstrated in preclinical assays, we introduced modifications into the conventional process towards getting a simpler and more economical process for further scale-up. Elimination of the extrusion step, increasing the lipid concentration (from 16 to 64 mM) of the preformed liposomes and using good manufacturing practice bulk lipids (96-98% purity) instead of analytical grade purity lipids (99.9-100%) were the modifications studied. The differences in the physico-chemical properties, such as average diameter, zeta potential, melting point and morphology of the liposomes prepared through the modified process, were not as significant for the biological properties, such as DNA loading on the cationic liposomes, and effective immune response in mice after immunisation as the control liposomes prepared through the conventional process. Beneficially, the modified process increased productivity by 22% and reduced the cost of raw material by 75%.29759-6

Effects of extrusion, lipid concentration and purity on physico-chemical and biological properties of cationic liposomes for gene vaccine applications

We developed cationic liposomes containing DNA through a conventional process involving steps of (i) preformation of liposomes, (ii) extrusion, (iii) drying and rehydration and (iv) DNA complexation. Owing to its high prophylactic potentiality against tuberculosis, which had already been demonstrated in preclinical assays, we introduced modifications into the conventional process towards getting a simpler and more economical process for further scale-up. Elimination of the extrusion step, increasing the lipid concentration (from 16 to 64 mM) of the preformed liposomes and using good manufacturing practice bulk lipids (96-98% purity) instead of analytical grade purity lipids (99.9-100%) were the modifications studied. The differences in the physico-chemical properties, such as average diameter, zeta potential, melting point and morphology of the liposomes prepared through the modified process, were not as significant for the biological properties, such as DNA loading on the cationic liposomes, and effective immune response in mice after immunisation as the control liposomes prepared through the conventional process. Beneficially, the modified process increased productivity by 22% and reduced the cost of raw material by 75%.Fundacao de Auxilio a Pesquisa do Estado de Sao Paulo (FAPESP)Fundacao de Auxilio a Pesquisa do Estado de Sao Paulo (FAPESP