Perfusion operation mode is currently under fast expansion in mammalian cell based manufacturing of biopharmaceuticals, not only for labile drug protein but also for stable proteins such as monoclonal antibodies (mAbs). Perfusion mode can advantageously offer a stable cell environment, long-term production with high productivity and consistent product quality. Intensified high cell density culture (HCDC) is certainly one of the most attractive features of a perfusion process due to the high volumetric productivity in a small footprint that it can provide. Advancements in single-use technology have alleviated the intrinsic complexity of perfusion processes while the maturing in cell retention devices has improved process robustness. The knowledge for perfusion process has been gradually built and the “continuous” concept is getting more and more acceptance in the field. This thesis presents the development of robust perfusion process at very high cell densities in various culture systems. Four HCDC perfusion systems were developed with industrial collaborators with three different mAb producing Chinese Hamster Ovary (CHO) cell lines: 1-2) WAVE Bioreactor™ Cellbag prototype equipped with cell separation by hollow fiber filter utilizing Alternating Tangential Flow (ATF) and Tangential Flow Filtration (TFF) techniques; 3) Fiber matrix based CellTank™ prototype; 4) Glass stirred tank bioreactor equipped with ATF. In all the systems, extremely high viable cell densities above 130 million viable cells per milliliter (MVC/mL) up to 214 MVC/mL were achieved. Steady states were maintained and studied at 20-30 MVC/mL and 100-130 MVC/mL for process development. Perfusion rate selection based on cell specific perfusion rate (CSPR) was systematically investigated and exometabolome study was performed to explore the metabolic footprint of HCDC perfusion process. / <p>QC 20170523</p>

Aiming at applications in space exploration as well as for monitoring natural hazards, this thesis focuses on understanding and overcoming the challenges of extending the applicability of microsystems to temperatures above 600°C as well as chemically harsh environments. Alumina and zirconia high-temperature co-fired ceramics (HTCC) with platinum as the conductor material, have in this thesis, been used to manufacture a wide range of high-temperature tolerant miniaturized sensors and actuators, including pressure and flow sensors, valves, a combustor, and liquid monopropellant microthrusters. Interfacing for high temperatures is challenging. One solution is to transfer the signal wirelessly. Here, therefor, wireless pressure sensors have been developed and characterized up to 1000°C. It is usually unwanted that material properties change with temperature, but by using smart designs, such changes can be exploited to sense physical properties as in the gas flow sensor presented, where the temperature-dependent electrical conductivity of zirconia has been utilized. In the same manner, various properties of platinum have been exploited to make temperature sensors, heaters and catalytic beds. By in-situ electroplating metals after sintering, even more capabilities were added, since many metals that do not tolerate HTCC processing can be added for additional functionality. An electroplated copper layer that was oxidized and used as an oxygen source in an alumina combustor intended for burning organic samples prior to sample analysis in a lab on a chip system, and a silver layer used as a catalyst in order to decompose hydrogen peroxide in a microthuster for spacecraft attitude control, are both examples that have been explored here. Ceramics are both high-temperature tolerant and chemically resistant, making them suitable for both thrusters and combustors. The corresponding applications benefit from miniaturization of them in terms of decreased mass, power consumption, integration potential, and reduced sample waste. Integrating many functions using as few materials as possible, is important when it comes to microsystems for harsh environments. This thesis has shown the high potential of co-fired ceramics in manufacturing microsystems for aggressive environments. However, interfacing is yet a major challenge to overcome.

På europeiska stränder utgör plast som bland annat muggar och bestick en stor andel av det marina skräpet. För att begränsa resursanvändning och nedskräpning bedriver IVL Svenska Miljöinstitutet ett forskningsprojekt där ett retursystem för take away-förpackningar implementerats på elva restauranger och kaféer i Sverige. Syftet med denna rapport är att undersöka materialvalet för matlådorna och muggarna som används och retursystemet i sin helhet ur ett användarperspektiv. För att göra detta genomfördes en enkätundersökning som riktade sig mot studenter på universitet och högskolor i Sverige. Detta retursystem är en typ av cirkulärt system som anses vara eftersträvansvärt inom både Sverige och EU. Inom ramarna för en cirkulär ekonomi kan det uppstå möjligheter för företag att utveckla nya affärsmodeller. Därmed finns det också ett flertal exempel på andra återbrukssystem. Som en del av det forskningsprojekt som samordnas av IVL genomförde också Antrop tre olika typer av undersökningar under år 2019 där viktiga faktorer för ett välfungerande retursystem diskuterades. För den enkät som genomfördes inom ramarna för denna rapport behandlades 217 stycken svar. Enkäten behandlade både allmänna frågor om respondentens attityd till retursystemet för take away-förpackningar och specifika frågor om retursystemet. De viktigaste slutsatserna som dragits är att faktorer som att systemet är enkelt och bekvämt att använda samt att hygienen inom systemet kan säkerställas har stor betydelse för kunderna. Det är möjligt att vissa av dessa potentiella hinder skulle kunna minimeras genom att retursystemet är tillgänglig i så stor utsträckning som möjligt. Viktigt att ha i åtanke är dock att attityder kan vara svåra att mäta, till exempel eftersom de inte alltid är kopplade till faktiska beteenden. / Plastic, for example cups and cutlery, constitutes a large portion of marine debris on european beaches. IVL, the Swedish Environmental Research Institute, is conducting a research project where a system of reuse for take away packaging has been implemented on eleven restaurants and cafés in Sweden to minimise resource utilization and littering. The purpose of this report is to examine this system of reuse as well as the materials used for the food containers and beverage cups within the system from a users perspective. To do this, a survey aimed at students at swedish universities was conducted. This system of reuse is a type of circulatory system which is something that is regarded as desirable in both Sweden and the EU. There is a possibility for companies to develop new business models within the limits of a circular economy, and evidently there are numerous examples of other systems of reuse that has been developed. As a part of the project that is coordinated by IVL, different surveys were conducted by Antrop during 2019 where important factors for a well functioning system of reuse were discussed. Regarding the survey that was conducted as a part of this report, 217 responses were processed. The survey dealt with both general questions regarding the respondents view of the system of reuse for take away packaging as well as specific questions regarding the system of reuse. The most important conclusions drawn where that it is important for the customers that the system is easy to use and that requirements regarding hygiene is fulfilled. It is possible that some of these obstacles could be minimised if the system of reuse have as good accessibility as possible. However, it is important to keep in mind that it can be difficult to measure attitudes as they are not always directly connected to behavior.

O trabalho teve como objetivo desenvolver uma proposta metodológica para análise dos custos de reprocessamento de pinças de dissecção, apreensão e corte, de uso único, utilizadas em cirurgia vídeo-assistida. O reuso desses artigos é prática freqüente, no Brasil e em diversos países, tendo como justificativa seu alto custo, embora sua viabilidade técnica não tenha sido comprovada. O reuso de artigos de uso único ainda é controverso e tem sido discutido e estudado sob os aspectos técnicos, legais, éticos e de segurança. Apesar da preocupação econômica, poucos estudos foram desenvolvidos sobre o real impacto econômico do reuso e reprocessamento. Neste trabalho, foi desenvolvida proposta metodológica para cálculo de custos e aplicada em três hospitais do Estado de São Paulo, seguindo o método de estudo de casos múltiplos. Foram coletados dados referentes a três meses nas instituições pesquisadas, por meio de observação e mensuração dos tempos das diversas fases do reprocessamento, revisão de registros da Central de Materiais e Esterilização e informações do Departamento de Recursos Humanos, Almoxarifado e Lavanderia. O custo do reprocessamento mensurado foi de R$9,374 no hospital Caso nº 1, de R$6,591 no Caso nº 2 e de R$3,312 no Caso nº 3. O baixo custo verificado deve ser analisado com grande cautela para que não seja interpretado como uma justificativa ao reuso desenfreado. Ao contrário, o baixo custo é motivo de preocupação, sobretudo quando se observa que o controle de qualidade, nos três casos analisados, tem pequena participação na composição do custo final. Nenhuma das instituições adota os controles de qualidade recomendados para garantir a segurança do reprocessamento. Segundo a Associação Canadense de Assistência à Saúde (Canadian Healthcare Association), devem ser realizadas a validação do reprocessamento e a avaliação anual que incluem inspeções da limpeza dos artigos, testes de esterilidade e análise de pirógenos e de resíduos dos agentes esterilizantes. Com os dados obtidos no estudo, foi elaborada uma estimativa do custo do reprocessamento, caso fossem realizadas a validação e a avaliação anual do reuso, empregando os testes de controle de qualidade. O custo do reprocessamento, considerando a possibilidade de dez reusos do artigo, passaria a ser de R$185,19 no Caso nº 1 e R$363,10 no Caso nº 3. No Caso nº 2, em razão da baixa utilização das pinças do estudo, somente haveria vantagem econômica se o número de reusos fosse restrito a três reutilizações; o custo do reprocessamento passaria a R$595,82 o que corresponderia a 58% do preço do artigo novo. A economia anual obtida pelo reuso da pinça de corte de uso único seria de R$577.818,36 no Caso nº 1, de R$51.501,60 no Caso nº 2 e de R$275.350,40 no Caso nº 3. A grande diferença observada na economia dos casos analisados está diretamente relacionada ao número de artigos empregados anualmente e aos gastos referentes à validação e avaliação anual do reprocessamento. A economia possível não elimina a necessidade de serem analisados outros aspectos relacionados ao reuso, em especial, os técnicos e de segurança. / This study aimed to develop a methodological proposal for reprocessing cost analysis of dissection, apprehension and cutting single use instruments used in video-assisted surgeries. Reuse of such articles is a frequent practice in Brazil and many other countries, justified by their high cost, although technical viability of the process hasn’t been established. Single use articles reuse is still a controversial issue and technical, legal, ethical and safety aspects have been discussed and studied. In spite of the financial concern involved, few studies have approached the real economic impact of reuse and reprocessing of single use items. In this study a methodological proposal developed for cost calculation was applied in three hospitals in São Paulo State, according to the multiple cases study method. Data was collected comprising a three month period in the researched institutions, through observation and time measuring of the various reprocessing phases, record revision from Central Supply and Sterilization Unit and information gathered at the Human Resources Department, Articles Supply and Laundry Units. Reprocessing costs measured were of R$9,374 in hospital Case number 1, R$6,591 in Case number 2 and R$3,312 in Case number 3. Low reprocessing costs found in this study should be analyzed with great care in order to avoid interpretation as a justification for unrestrained reuse. On the contrary, the low reprocessing cost gives reason to concern when it is observed that quality control, in all three analyzed cases, has little participation in the final cost. Neither one of the institutions adopts quality control protocols recommended for reprocessing safety assurance. According to the Canadian Healthcare Association, reprocessing process validation must be undertaken as well as annual evaluations which includes cleanliness inspection of the articles, pirogenic substances analyses, sterility testing and sterilizing agents residue analysis. An estimate of the reprocessing cost was elaborated considering a scenario where process validation and annual evaluations were performed, through quality assurance tests. Reprocessing costs, considering the possibility of 10 article reuses, would then be of R$ 185,19 in Case number 1 and of R$ 363,10 in Case number 3. Regarding Case number 2, due to the low rate of usage of the article, there would only be a financial advantage if the number of reuse would be restricted to 3 reutilizations: reprocessing costs would then be R$ 595,82 which corresponds to 58% of the price of a new article. Annual economic saving obtained through reuse of the single use cutting instrument would be of R$ 577.818,36 in Case number 1, of R$51.501,60 in Case number 2 and of R$ 275.350,40 in Case number 3. The great difference observed in the savings for the analyzed cases is directly related to the number of articles used annually and to the expenses related to validation processes and the reprocessing protocol annual evaluation. Financial saving obtained does not eliminate the need to analyze other aspects related to reuse, mainly those concerning technical and safety aspects.

Made available in DSpace on 2016-06-02T19:56:57Z (GMT). No. of bitstreams: 1 6615.pdf: 4694610 bytes, checksum: 288df2441cd04d5e5e4c36da49c66cb9 (MD5) Previous issue date: 2015-03-05 / Financiadora de Estudos e Projetos / Mesenchymal stromal cells (MSCs) are required by the scientific community in the development and enhancement of therapeutic techniques in different fields of medicine. The MSCs are present in small concentrations in tissues, which makes necessary the expansion in vitro for enable studies and therapeutic applicability. These are cells with high sensitivity to environmental conditions of cultivation. So, for increase productivity in vitro is used the technology of bioreactors in the development of processes in order to produce high cell densities in less time, with reduce use of resources and maintaining a safe operation. The new concepts of "disposable bioreactors", as the wave-induced motion bioreactor or Wave bioreactor, with possibility operating in a closed system, controlled and automated, reduced investment cost and operation, less risk of contamination, higher level biosecurity, added to the fact of being a underexplored technology and already approved by the FDA (Food and Drugs Administration) becomes a highly attractive alternative bioprocessing for cultivation of animal cells in large scale. In this context, the present work aims to develop a protocol for cultivation of MSCs in the Wave Bioreactor System 2/10. Experiments were performed to characterize the CEMs's culture behavior in the Wave bioreactor to obtain high cell productivity while maintaining the therapeutic potential of the CEMs. The experiments were carried out with 2 L Cellbag and Cultispher-S microcarrier with 300 ml of &#945;-MEM medium culture supplemented with glucose, glutamine, and arginine and 15% v/v fetal bovine serum at 37 ° C and pH between 6,9-7,4. In the preliminary experiments it was verified that most of the inoculated cells did not adhere to the microcarriers. It was shown that such behavior is due to low relation between adhesion area (AMC = total projected area of the microcarriers) and wet surface area of Cellbag (ASMCellbag), which in the normal condition of operation results an adhesion between 25,7 and 61,7% of the inoculated cells. To solve the problem were performed experiments reducing ACellbag which enabled improvements in cell adhesion by up to 100%. It was also found low performance of the cell expansion phase, presumably linked to operational problems like: microcarriers segregation in certain regions of the bioreactor causing depletion of nutrients, formation of aggregates of MCs colonized with cells and adhesion of MCs to Cellbag. In addition, it was observed that reducing CEM/MC ratio at the start of the culture, the cell expansion factor could be increased to values equal to or greater than 10. These results show that the Wave bioreactor has good potential for expansion of MSCs and that the same can be improved. / As células estromais mesenquimais (CEMs) estão sendo visadas pela comunidade científica no desenvolvimento e aprimoramento de técnicas terapêuticas em diferentes ramos da medicina. As CEMs estão presentes em pequenas concentrações nos tecidos, o que torna necessário a sua expansão in vitro para viabilizar pesquisas e a aplicabilidade terapêutica. Tratam-se de células com elevada sensibilidade em relação às condições do ambiente de cult ivo. Assim, para o aumento da produtividade in vitro utiliza-se a tecnologia de biorreatores no desenvolvimento de processos com objetivo de produzir altas densidades celulares em curto tempo, de forma econômica e respeitando as normas impostas pelos órgãos reguladores. O novo conceito de biorreator descartável, como o do biorreator com movimento induzido em forma de ondas, ou biorreator Wave, apresenta possibilidade de operação em sistema fechado segundo as boas práticas de fabricação (BPF), controlado e automatizado. O custo de investimento e operação reduzido, com menor risco de contaminação, maior nível de biossegurança, somado ao fato de utilizar uma tecnologia pouco explorada e já aprovada pelo FDA (Food and Drugs Administration) se transforma numa alternativa de bioprocessamento altamente atrativa para cultivo de células animais em larga escala. Nesse contexto, o presente trabalho tem por meta avaliar o desempenho do biorreator Wave 2/10 na expansão das CEMs. Para tal, foram realizados experimentos visando caracterizar o comportamento do cultivo nesse biorreator a fim de obter alta produtividade celular mantendo a potencialidade terapêutica das CEMs. Os experimentos foram realizados com saco plástico (doravante Cellbag) de 2 L e microcarregador (MC) Cultispher-S com 300 mL me io de cultivo &#945;-MEM suplementado com glicose, glutamina e arginina e 15% v/v de soro fetal bovino a 37°C e pH entre 6,9-7,4. Nos experimentos preliminares constatou-se que grande parte das células inoculadas não aderiam aos microcarregadores. Comprovou-se que tal comportamento se devia à baixa relação entre área de adesão (AMC = área total projetada dos microcarregadores) e área de superfície molhada da Cellbag (ASMCellbag) que na condição normal de operação resultava numa adesão entre 25,7 e 61,7% das células inoculadas. Para melhorar a adesão foram realizados experimentos reduzindo a ASMCellbag, o que possibilitou melhoria na adesão celular em até 100%. Na etapa de expansão celular verificou-se baixo desempenho, presumivelmente vinculado a problemas de operação como: segregação de microcarregadores em determinadas regiões do biorreator provocando o esgotamento de nutrientes, formação de agregados de MCs colonizados com células e adesão dos MCs à Cellbag. Em adição, notou-se que diminuindo a relação CEM/MC no início do cultivo a expansão celular podia ser aumentada para valores iguais ou maiores que 10. Ao todo, os resultados mostraram que o biorreator Wave possui bom potencial para a expansão de CEMs e que o mesmo ainda pode ser melhorado.

O trabalho teve como objetivo desenvolver uma proposta metodológica para análise dos custos de reprocessamento de pinças de dissecção, apreensão e corte, de uso único, utilizadas em cirurgia vídeo-assistida. O reuso desses artigos é prática freqüente, no Brasil e em diversos países, tendo como justificativa seu alto custo, embora sua viabilidade técnica não tenha sido comprovada. O reuso de artigos de uso único ainda é controverso e tem sido discutido e estudado sob os aspectos técnicos, legais, éticos e de segurança. Apesar da preocupação econômica, poucos estudos foram desenvolvidos sobre o real impacto econômico do reuso e reprocessamento. Neste trabalho, foi desenvolvida proposta metodológica para cálculo de custos e aplicada em três hospitais do Estado de São Paulo, seguindo o método de estudo de casos múltiplos. Foram coletados dados referentes a três meses nas instituições pesquisadas, por meio de observação e mensuração dos tempos das diversas fases do reprocessamento, revisão de registros da Central de Materiais e Esterilização e informações do Departamento de Recursos Humanos, Almoxarifado e Lavanderia. O custo do reprocessamento mensurado foi de R$9,374 no hospital Caso nº 1, de R$6,591 no Caso nº 2 e de R$3,312 no Caso nº 3. O baixo custo verificado deve ser analisado com grande cautela para que não seja interpretado como uma justificativa ao reuso desenfreado. Ao contrário, o baixo custo é motivo de preocupação, sobretudo quando se observa que o controle de qualidade, nos três casos analisados, tem pequena participação na composição do custo final. Nenhuma das instituições adota os controles de qualidade recomendados para garantir a segurança do reprocessamento. Segundo a Associação Canadense de Assistência à Saúde (Canadian Healthcare Association), devem ser realizadas a validação do reprocessamento e a avaliação anual que incluem inspeções da limpeza dos artigos, testes de esterilidade e análise de pirógenos e de resíduos dos agentes esterilizantes. Com os dados obtidos no estudo, foi elaborada uma estimativa do custo do reprocessamento, caso fossem realizadas a validação e a avaliação anual do reuso, empregando os testes de controle de qualidade. O custo do reprocessamento, considerando a possibilidade de dez reusos do artigo, passaria a ser de R$185,19 no Caso nº 1 e R$363,10 no Caso nº 3. No Caso nº 2, em razão da baixa utilização das pinças do estudo, somente haveria vantagem econômica se o número de reusos fosse restrito a três reutilizações; o custo do reprocessamento passaria a R$595,82 o que corresponderia a 58% do preço do artigo novo. A economia anual obtida pelo reuso da pinça de corte de uso único seria de R$577.818,36 no Caso nº 1, de R$51.501,60 no Caso nº 2 e de R$275.350,40 no Caso nº 3. A grande diferença observada na economia dos casos analisados está diretamente relacionada ao número de artigos empregados anualmente e aos gastos referentes à validação e avaliação anual do reprocessamento. A economia possível não elimina a necessidade de serem analisados outros aspectos relacionados ao reuso, em especial, os técnicos e de segurança. / This study aimed to develop a methodological proposal for reprocessing cost analysis of dissection, apprehension and cutting single use instruments used in video-assisted surgeries. Reuse of such articles is a frequent practice in Brazil and many other countries, justified by their high cost, although technical viability of the process hasn’t been established. Single use articles reuse is still a controversial issue and technical, legal, ethical and safety aspects have been discussed and studied. In spite of the financial concern involved, few studies have approached the real economic impact of reuse and reprocessing of single use items. In this study a methodological proposal developed for cost calculation was applied in three hospitals in São Paulo State, according to the multiple cases study method. Data was collected comprising a three month period in the researched institutions, through observation and time measuring of the various reprocessing phases, record revision from Central Supply and Sterilization Unit and information gathered at the Human Resources Department, Articles Supply and Laundry Units. Reprocessing costs measured were of R$9,374 in hospital Case number 1, R$6,591 in Case number 2 and R$3,312 in Case number 3. Low reprocessing costs found in this study should be analyzed with great care in order to avoid interpretation as a justification for unrestrained reuse. On the contrary, the low reprocessing cost gives reason to concern when it is observed that quality control, in all three analyzed cases, has little participation in the final cost. Neither one of the institutions adopts quality control protocols recommended for reprocessing safety assurance. According to the Canadian Healthcare Association, reprocessing process validation must be undertaken as well as annual evaluations which includes cleanliness inspection of the articles, pirogenic substances analyses, sterility testing and sterilizing agents residue analysis. An estimate of the reprocessing cost was elaborated considering a scenario where process validation and annual evaluations were performed, through quality assurance tests. Reprocessing costs, considering the possibility of 10 article reuses, would then be of R$ 185,19 in Case number 1 and of R$ 363,10 in Case number 3. Regarding Case number 2, due to the low rate of usage of the article, there would only be a financial advantage if the number of reuse would be restricted to 3 reutilizations: reprocessing costs would then be R$ 595,82 which corresponds to 58% of the price of a new article. Annual economic saving obtained through reuse of the single use cutting instrument would be of R$ 577.818,36 in Case number 1, of R$51.501,60 in Case number 2 and of R$ 275.350,40 in Case number 3. The great difference observed in the savings for the analyzed cases is directly related to the number of articles used annually and to the expenses related to validation processes and the reprocessing protocol annual evaluation. Financial saving obtained does not eliminate the need to analyze other aspects related to reuse, mainly those concerning technical and safety aspects.

Rapportens syfte är att utveckla en modell bestående av ersättningsalternativ till plast samt verktyg som verksamheter kan tillämpa för att bidra till en global reducering av plast. Således formulerades rapportens tre forskningsfrågor enligt: “Vilket av de utvärderade ersättningsalternativen är enligt modellens ramverk mest lämpad för att konkurrera medtraditionell plasttillverkning?”, “Hur kan modellens utformning hjälpa användaren att ställa om sin verksamhet sett till att ersätta engångsprodukter i plast?” samt “Hur kan ersättandet av engångsprodukter i plast bidra till uppfyllandet av de globala målen?”. För att besvara rapportens forskningsfrågor genomfördes en fallstudie i form av ett samarbete med företaget PulPac AB. Företaget har uppfunnit en tillverkningsteknik vid namn PulPactorrfomning, vilken tillsammans med våtformning och termoformning av bioplaster, utgörrapportens jämförelse över konkurrenskraftiga ersättningsalternativ till den traditionella plasttillverkningen. Litteraturstudien innefattade dels en teoretisk bakgrund om plasten och dess påföljder, en ingående beskrivning av de olika ersättningsalternativen samt definiering avhållbarhetsbegrepp och politiska styrmedel. Dels en bearbetning av data från ett urval avfallstudier med utgångspunkt i att sammanställa faktorer och kriterier till modellens utformning. Resultatet består huvudsakligen av rapportens modell ”Modellen för ersättning av engångsplast”, som innefattar de fyra stegen: jämförelse mellan ersättningsalternativ, värdering&amp; val av alternativ, integrering av kärnfaktorer i verksamheten samt utvärderingsfrågor. Utifrån jämförelsen av modellens formulerade kriterier uppfyllde tekniken PulPac torrformning flest utav faktorerna och anses därmed vara mest lämpad att konkurrera med traditionell plasttillverkning. Vidare presenteras modellens utformning som ett bistående hjälpmedel för att underlätta omställning till ett ersättningsalternativ genom att praktiskt tillämpa tillhandahållna implementeringsverktyg. Ersättandet av engångsprodukter i plast bidrar till uppfyllandet av FN:s globala mål genom att successivt fasa ut plastprodukter och därmed bidra till en global reducering av plast. På så sätt kan konsekvenserna av ett ersättningsalternativ ha en positivpåverkan på samhällsutvecklingen då det resulterar i minskade hälsorisker och nedskräpningav plaster. Sett till vidareutveckling av modellen föreslås främst att införa kriterier för vilka produkttyper som är lämpade att börja ersätta, vilket lyfts fram som rapportens förslag till vidare forskning. Företaget rekommenderas att använda modellen för informationsspridning inom kundnätverk och i egensyfte vid jämförelse mot andra alternativ inom branschen. / The purpose of the report is to develop a model based on replacement alternatives to plastics as well as providing tools which can be applied to contribute to a global reduction of plastics. Thus, the three following research questions were formulated: ”Which of the evaluated replacement alternatives are the most suited to compete with traditional plastic manufacturing according to the framework of the model?”, “How can the design of the model assist the user in rearranging their organisation in order to replace single-use plastics?” and “How can the replacement of single-use plastics contribute to fulfilment of the global goals”?. In order to answer the research questions of the report, a case study was conducted, in terms of a collaboration with the company PulPac AB. The company has invented a manufacturing method called the dry moulded fibre process, which together with the traditional paper making process and thermoforming of bioplastics, accounts for the report’s comparison of potential alternatives to replace traditional manufacturing of plastics. On one hand, the literature study of the report consists of a theoretical background of plastics and its effects, an in-depth description of the replacement alternatives as well as definitions of sustainability terminology and tools for policy makers. On the other hand, it includes processing of a range of external case studies, in order to compile parameters to the design of the model. The key parts of the results include “The Model of Replacement of Single-use Plastics”, which consists of the four-steps: comparison of replacement alternatives, evaluation &amp; selection of alternative, integration of core factors in the organizational structure and evaluation questions. Based on the comparison of the defined criteria, the dry moulded fibre process was the replacement alternative fulfilling most factors and thereby also the one most suited to compete with traditional manufacturing of plastics. Moreover, the design of the model can be applied as an assisting tool in order to facilitate implementation of the selected replacement alternative. The replacement of single-use plastics can contribute to fulfilling the global goals by phasing out plastic products and thereby further contribute to a global reduction of plastics. Thus, a replacement alternative can have a positive effect on social development since it results in decreased health risks as well as reduced plastic pollution. The suggestion to further research within the area, involves investigating the possibilities of developing and expanding the model with additional criteria regarding which range of products that are the most suitable to start replacing. Furthermore, the case company is recommended to use the model as a tool to increase the information flow within their network, by benchmarking their method against other techniques within the industry.

This study has its background in the EU directive, the ‘Single-Use Plastics Directive’. The directive was initiated due to the environmental impacts that the oceans suffer due to plastic waste. The directive presents the most common single-use products found as waste in the oceans, including wipes and cloths. In collaboration with Essity, a global hygiene and health company, this study aims to find a replacement fibre for the currently used polyester fibre in Essity’s industrial cleaning cloths. To this end, we have evaluated the applicability of an agricultural fibre in the aspects of processability and sustainability. A theoretical part including a literature study of agricultural fibres is combined with a practical experimental part to evaluate a manufactured prototype. The theoretical part includes a compilation of the relevant parameters per fibre and the experimental part consists of laboratory tests and a panel test. On this basis, it was concluded that the first agricultural fibre, hemp, did not function adequately in the process due to the variations in fibre length and coarseness. A solution to this problem may be pre-treatments of the fibres. The second fibre, flax, functioned well in the process and may then be considered applicable in the aspect of process. The applicability of an agricultural fibre is possible in industrial cleaning cloths, but the geographical location of cultivation, transport, the chemicals used and irrigation should also be taken into account in the aspects of sustainability. / Bakgrunden till denna studie är EU-direktivet, ‘Single-Use Plastics Directive’. Direktivet har sitt ursprung i de miljöproblem som våra hav lider av på grund av nedskräpningen medplastavfall. Direktivet redovisar de engångsartiklar som återfinns allra mest i haven idag, däribland rengöringsdukar. På förekommen anledningen ska därför denna studie i samarbete med Essity, ett globalt hygien- och hälsoföretag, undersöka möjligheten att ersätta den befintliga polyesterfibern i deras industriella rengöringsdukar. Studien har utvärderat möjligheten att använda en naturlig fiber med avseende på tillverkningsprocess och hållbarhet. För att möjliggöra en utvärdering av en tillverkad prototyp, så har en teoretisk del med en litteraturstudie i kombination med en praktisk experimentell del genomförts. Den teoretiska delen består av en sammanställning av relevanta parametrar för varje fiber och den experimentella delen består av laboratorietester och ett paneltest. Slutsatserna från ett förstaförsök var att hampafibrer inte fungerade i processen på grund av variationer i hampansfiberlängd och grovlek. Att göra en förbehandling skulle kunna vara lösningen. I det andraförsöket med linfibrer, visade det sig att linfibrer fungerar i processen och därför kan vara applicerbar med avseende på tillverkningsprocess. En naturlig fiber kan användas i industriella rengöringsdukar, ur ett hållbarhetsperspektiv är det viktigt att beakta den geografiska platsen för odling, transporter, användning av kemikalier och konstbevattning.

Inom hälso- och sjukvården används stora mängder plast i allt från medicinska instrument till mat- och dryckesservering samt lokalvård. Plasten besitter egenskapersom både bidrar till att upprätthålla höga hygienkrav och skyddar mot livshotande virus. Stora mängder engångsplastprodukter används både eftersom det förenklarmaterialhantering för vårdpersonal samt eftersom flergångsprodukter ofta förknippas med infektionsrisker. Majoriteten av hälso- och sjukvårdens plastavfall förbrännsdäremot efter användning, vilket bidrar till ökade klimatförändringar och begränsarmöjligheterna att uppnå globala hållbarhetsmål. Då plasten anses nödvändig inomexempelvis sjukvården kan den inte helt fasas ut, däremot behöver materialåtervinningen öka. Ett hinder för återvinning är att plastavfallet potentiellt kan vara kontaminerat av läkemedel, kroppsvätskor eller smittförande ämnen som riskerar att vara hälso- ochmiljöskadliga. Plastavfall som blir kontaminerat kräver därför separat hantering frånövrigt avfall och ofta är det osäkert om avfallet är kontaminerat eller inte. Dennastudie ämnade att undersöka hur engångsplastprodukter hanteras inom hälso- ochsjukvården samt eventuella möjligheter och hinder för att skapa mer cirkulära plastflöden genom ökad materialåtervinning. Detta genom en kombination av en litteraturstudie och en fallstudie där möjliga åtgärder identifierades. Fallstudien genomfördes på lungmottagningen och kirurgavdelningen vid Gävle sjukhus där informationfrämst samlades in genom observationer och personlig kommunikation. Studien omfattar även en granskning av de besökta verksamheternas inköpsstatistik för att identifiera vilka plasttyper som förekommer i deras produkter. Resultatet tyder på att åtgärder för att underlätta en effektiv materialåtervinning avsjukvårdsplast kräver samarbete mellan aktörer i olika delar av produktens värdekedja, från de tillverkare som designar produkterna till de återvinnare som hanteraravfallet. För de besökta verksamheterna på Gävle sjukhus är några av de största hindren relaterade till platsbrist för utökad avfallssortering samt en stor variation av olikaplasttyper och material i de produkter som används. Slutsatser som kan dras är atten mer grundlig sammanställning av materialsammansättning i produkterna än densom återfinns i denna studie och en nära dialog med återvinnare krävs, för att implementera åtgärder för utökad materialåtervinning. En ökad utsortering av plastavfallfrån hälso- och sjukvården anses vara möjlig, men olika åtgärder kan krävas för olikatyper av plastavfall. / The healthcare sector consumes large amounts of plastic for different applications,from medical instruments to food and beverage service and facility maintenance.The properties of the plastics contribute to maintaining high hygiene standards andprovide protection against life-threatening viruses. Large quantities of single-useplastic products are used because it simplifies the work of healthcare staff and because reusable products are often associated with risks of infection. The majority ofplastic waste within healthcare is incinerated after use, which contributes to increased climate change and limits the opportunities to achieve global goals of sustainability. Since plastic is considered necessary within the healthcare sector, it cannot be completely phased out but the material recycling needs to be increased.  One obstacle to recycling is that the plastic waste can potentially be contaminated bypharmaceuticals, body fluids or infectious substances that risk being harmful tohealth and the environment. Contaminated plastic waste therefore requires separatehandling from other waste and it is often uncertain whether the waste is contaminated or not. This study aimed to investigate how single-use plastic products aremanaged within healthcare and potential opportunities and obstacles to create morecircular plastic flows through increased material recycling. This was done through acombination of a literature review and a case study where possible measures wereidentified. The case study was conducted at the Lung Department and the SurgeryDepartment at the Hospital of Gävle, where information was primarily collectedthrough a series of observations and personal communication. The study also includes an investigation of the purchasing statistics of the visited departments in orderto identify the types of plastic found in their products.  The results indicate that measures to facilitate an efficient material recycling ofhealthcare plastic require cooperation between actors in different parts of theproduct's value chain, from the manufacturers who design the products to the recyclers who handle the waste. For the visited departments at the Hospital of Gävle,some of the biggest obstacles are related to a lack of space for expanded waste sorting as well as a large variety of different types of plastic and materials in the productsused. Conclusions that can be drawn are that a more thorough compilation of material composition in the products than that found in this study, and a close dialoguewith recyclers, are required to implement measures for increased material recycling. An increased sorting of plastic waste from healthcare is considered possible,but different measures may be required for different types of plastic waste.

Os materiais de uso único (MUU) são utilizados há décadas na assistência à saúde. Inicialmente produzidos com a finalidade de prontamente disponibilizar os materiais para uso na assistência a saúde e ao mesmo tempo diminuir a sobrecarga com o trabalho inerente ao reprocessamento dos materiais. Com o passar do tempo, principalmente por questões financeiras, estes passaram a ser reutilizados. A partir de então diversos questionamentos têm sido suscitados a respeito do risco de transmissão de infecção pelo reuso destes artigos em decorrência da dificuldade para de limpeza, desinfecção e esterilização seguras destes. Os materiais utilizados para as cirurgias vídeo-laparoscópicas encontram-se entre os MUU de preço considerável e complexidade importante em relação às dificuldades para limpeza, devido à sua conformação com espaços internos inacessíveis e impossibilidade de desmonte. Isto posto, as pinças grasper, dissector, tesoura, agulha de Veress, sistema de sonda de eletrocirurgia (ou aspirador e irrigador) e sua respectiva haste, instrumentais básicos nos procedimentos de vídeo-cirurgia-laparoscópica, foram o objeto desta investigação com o propósito de avaliar a eficácia da esterilidade destes acessórios de uso único após contaminação artificial desafio e comparar os resultados dos testes de esterilidade dos MUU com os dos materiais equivalentes reprocessáveis – denominados neste estudo como grupo controle. Tratou-se de uma pesquisa experimental, laboratorial e comparativa. O inóculo utilizado para a contaminação artificial dos instrumentais de uso único constituiu-se de suspensão de esporos bacterianos do Bacillus atrophaeus var. niger e de sangue de carneiro desfibrinado esterilizado. Para o grupo controle o microrganismo eleito foi o Geobacillus stearothermophilus acrescido também de sangue de carneiro desfibrinado. Antes de proceder aos experimentos validou-se a metodologia analítica em duas fases: fase 1 - realizada a contagem de U.F.C. em três unidades de cada um dos materiais dos grupos experimental e controle após a contaminação artificial antecedendo a limpeza; fase 2 - realizada a contagem de U.F.C. em três unidades de cada um dos materiais dos grupos experimental e controle após a contaminação artificial e procedimento de limpeza. Desta forma, assegurada a recuperação dos contaminantes em todas as amostras da primeira fase e a diminuição do bioburden inicial após a limpeza dos instrumentais na 2ª fase, deu-se prosseguimento aos experimentos. Os materiais laparoscópicos foram intencionalmente contaminados com o inóculo desafio e submetidos após ao protocolo teste para validação que consistiu da seguinte seqüência: limpeza automatizada em lavadora ultra-sônica com retrofluxo com auxílio do detergente enzimático, limpeza manual complementar com serpilhos e irrigação dos lumens dos instrumentais com água sob pressão. Por fim, foi realizado o enxágüe com água destilada esterilizada, secagem com ar comprimido medicinal, acondicionamento em embalagem de papel grau cirúrgico e filme e submetidos a esterilização em Óxido de Etileno 12/88 (materiais de uso único) e em autoclave (materiais de aço inoxidável). Os materiais esterilizados foram inoculados diretamente nos meios de cultura de caseína soja e incubados por 20 dias quando foi feita a leitura final dos resultados das culturas. Os resultados encontrados foram 100% negativos para a recuperação dos microrganismos contaminantes nos 2 grupos - experimental e controle. Estes achados permitiram concluir que o reprocessamento dos materiais de uso único foi validado em relação à esterilidade permitindo chegar a um protocolo de reprocessamento / Single use devices (SUD) have been used in healthcare for decades. They were initially produced for making them readily available for use in healthcare and at the same time lower the inherent workload for device reprocessing. After time, mainly for financial reasons, they became reused. Since then, several questioning has been raised regarding to the risk of infection transmission by reusing these devices due to their difficulty of safe cleaning, disinfection and sterilization. Devices used for videosurgeries are among the SUD of considerable price and important complexity due to cleaning difficulties, because of their adjustments in inaccessible inner spaces and impossibility of taking them out into pieces. Thus, grasper calipers, dissecting forceps, scissors, Veress insuflation needle, electrosurgery probe system (or suction and irrigation tubes) and its respective dissector cannula, basic devices in videosurgery laparoscopic procedures were all the subject of investigation aimed to evaluate the effectiveness of sterility of these single use products after challenged artificial contamination and comparing the results of sterility tests of SUD to their equivalent reprocessed devices – named in this study as control group. It’s a comparative, laboratory experimental research. The inoculum used for artificial contamination of single use devices was the suspension of Bacillus atrophaeus var. niger bacteria spores and sterilized defibrinated sheep blood. For the control group, the elected strain was Geobacillus stearothermophilus adding also the defibrinated sheep blood. Before carrying out the experiments, the analytical methodology was validated in two phases: phase 1 – counting the colony formation units in three units of each one of the devices from the experimental and control groups after the artificial contamination and cleaning procedures. This way, assured the contaminant recovery in all samples of the 1st phase and the reduction of initial bioburden after device cleaning in the 2nd phase, it was carried on the experiments. The laparoscopic devices were intentionally contaminated with challenged inoculum and submitted after the trial test to validation that was consisted of the following sequence: cleaning in automated narrow-lumen cleaner with enzymatic detergent, complementary manual cleaning with brush and lumen washing of devices with water under pressure. At last, it was made rinsing with sterile distillated water, drying with medical compressed air, packing in surgical paper and film wrapping and submitted to sterilization in ethylene oxide 12/88 (single use devices) and in autoclave (stainless steel devices). The sterilized devices were contaminated directly in the casein soy media and incubated for 20 days when it was made the final reading of media results. The outcomes found were 100% negative for recovering of contamination strains in the 2 groups – the experimental and the control. These findings permitted us to conclude that single use device reprocessing was validated regarding to sterility allowing us to get a reprocessing guideline