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A system of monitoring of power consumption processes in power supply infrastructure of clean rooms at microelectronics manufacturing enterprise is proposed in the article. Classification of basic process operations performed in clean rooms has been completed. The key factors for monitoring of energy consumption processes of microelectronics manufacturing enterprises have been determined. A comparative analysis of various techniques for forecasting of power consumption by an enterprise specializing in microelectronics production has been performed. It is discovered that systems with neural networks provide the highest resistance against external and internal disturbing factors. A solution of the problem of forecasting of power consumption with the use of Statistica Neural Network software suite is proposed. The results of numerical modelling of predicted and actual values of power consumption by clean rooms of electric infrastructure at microelectronics manufacturing enterprise on the basis of the developed software algorithm are presented.

Introducción: La elaboración de preparados farmacéuticos estériles requiere áreas limpias que deben cumplir estándares internacionales para minimizar la contaminación microbiana. Objetivo: Evaluar la calidad bacteriológica del aire de la Unidad de Preparados Farmacéuticos Estériles del Servicio de Farmacia del Hospital Clínico de la Universidad de Chile y establecer niveles de alerta y acción. Material y Métodos: Se monitorearon ocho puntos representativos de la unidad, diariamente entre enero y febrero de 2005 y bisemanal-mente de junio a febrero de 2006. Se estudiaron 839 muestras de aire, recolectadas mediante el método de impacto en placa (equipo MAS-100). Resultados: De las muestras estudiadas, 474 (56,5%) fueron positivas; de éstas, sólo 17 (3,5%) estuvieron fuera del rango permitido, porcentaje que representa el 2% del total. Las muestras de los sitios 1 y 2 (flujo laminar grande y pequeño), que corresponden al área de preparación de preparados estériles fueron negativas. Los sitios 3 (mesón) y 4 (transfer) presentaron ocasionalmente valores superiores a los límites. Los microorganismos más frecuentes fueron Staphylococcus coagulasa negativa, Micrococcus spp y Corynebacterium spp, agentes de la microbiota de la piel y, menor porcentaje, Bacillus spp, agente de la microbiota ambiental. Conclusiones: Desde el punto de vista microbiológico, la calidad del aire de la zona de preparaciones estériles descrita presenta niveles ajustados a estándares internacionales. El establecer niveles de alerta y acción institucionales y la identificación de los microorganismos obtenidos en las áreas más sensibles de la unidad permite cuantificar la carga microbiana y conocer sus componentes para determinar las intervenciones a realizar cuando ellas estén indicadas. Background: An extremely clean area is required for preparation of sterile pharmaceutical compounds, in compliance with international standards, to minimize the probability of microbial contamination. Aim: To evaluate the bacteriological quality of the air in the Sterile Pharmaceutical Preparation Unit of the University of Chile's Clinical Hospital and to set up alerts and action levels of bacterial growth. Methods: We studied eight representative sites of our Unit on a daily basis from January to February 2005 and twice a week from June 2005 to February 2006. We collected 839 samples of air by impact in the Petri dish. Results: 474 (56.5%) samples were positive; 17 (3.5%) of them had an inappropriate bacterial growth (2% of total samples). The samples from sites 1 and 2 (big and small biosafety cabinets) were negative. The countertop and transfer area occasionally exceeded the bacterial growth limits. The most frequently isolated bacteria were coagulase-negative staphylococci, Micrococcus spp and Corynebacterium spp, from skin microbiota, and Bacillus spp, an environmental bacteria. Conclusions: From a microbiological perspective, the air quality in our sterile preparation unit complied with international standards. Setting institutional alerts and action levels and appropriately identifying bacteria in sensitive areas permits quantification of the microbial load and application of preventive measures.

Para que sejam atendidos os requisitos normativos e reguladores dentro dos padrões nacionais e internacionais que tratam das condições inerentes à produção-processamento de materiais sensíveis à contaminação, tais como medicamentos injetáveis, um ambiente com atmosfera controlada deve ser criado. Tratando-se de materiais que têm aplicação medicinal, através de procedimentos específicos, mas que também apresentam em suas constituições agentes tóxicos, radioativos e periculosos, o ambiente deve assegurar que estes materiais, que em alguns casos possuem ainda característica de serem voláteis, não escapem para meio ambiente, sem que isto ocorra de uma maneira seletiva e segura, totalmente controlada. A condição de trabalho neste caso, recomendada pelas normas nacionais e internacionais vigentes, refere-se a uma atmosfera negativa em relação aos ambientes adjacentes. Apesar de a literatura estar amplamente provida de tecnologias referentes ao dimensionamento de sistemas, baseados em normas que determinam claramente os requisitos necessários, verifica-se a necessidade de desenvolver um ambiente controlado para produção de radiofármacos, compatibilizando o conceito de área limpa aos requisitos de segurança para manipulação de fontes radioativas abertas. Neste trabalho, dispositivos foram criados, métodos e procedimentos estabelecidos, com objetivo de possibilitar classificações diferentes do ar no interior da cela, sem barreiras físicas na área de trabalho, estabelecendo uma condição ergonômica, flexível e prática, refletindo em maior produtividade. O projeto resultou na criação de um ambiente totalmente favorável ao pronto atendimento dos requisitos normativos, composto de uma câmara de passagem responsável pela entrada e saída de material, sem que condições internas ao micro-ambiente fossem comprometidas. A estanqueidade da cela foi obtida utilizando-se portas dotadas de sistema eficiente de vedação através de juntas ativas e intertravamentos. Manipuladores tipo pinça asseguraram as operações de maneira ergonômica e segura, sem comprometer a estanqueidade e classificação do ambiente com graus de limpeza A e B. Para isso, utilizou-se um eficiente sistema de ventilação/ exaustão, dotado de filtros e dispositivos especiais desenvolvidos com exclusividade para que as condições impostas ao micro ambiente fossem estabelecidas a contento. Todos os parâmetros de funcionamento da cela foram avaliados através do planejamento de ensaios específicos. Os resultados dos ensaios demonstraram o atendimento aos critérios estabelecidos, indicando o potencial do projeto para o desenvolvimento de uma cela de produção de radiofármacos. A controlled ambient should be established to the production/processing of materials susceptible to contamination, like injectable pharmaceuticals, in order to agree with normative and regulatory requirements. Considering medical but also toxic, radioactive and dangerous products, the ambient should work in special conditions to assure that the materials, which in same cases can be also volatile, do not escape to the external ambient, working in a selective, secure and controlled way. The conditions recommended by local and international rules in use, report an negative pressured ambient in relation to the adjacent areas. The technology related with the sizing of project to this kind of system is fully described in the literature, taking in account the rules that clearly describe the essential requirements. However, it is necessary to develop a controlled ambient for radiopharmaceutical production, in a way compatible with the concept of clean rooms and with the safety related to the manipulation of open radioactive wastes. In this work, some devices were created, methods and procedures were established making possible the classification of the ambient inside the hot cell, without physical barriers in the area, using ergonomic, flexible and practical conditions of work, that can results in the improvement of the productivity. The project resulted in the creation of a controlled ambient, in agreement with the normative requirements, using a pass through for entrance and exit of the materials, without compromise the internal air condition. The tight of the hot cell was obtained using doors with efficient sealing system and active joints. Tong manipulators were used to produce ergonomic and secure conditions, without compromise the internal conditions related to tight and classification in A and B grade, according to local and international rules. An efficient ventilation/exhaustion system was adopted to produce these results, composed by filters and special devices, developed exclusively to produce ideal conditions in the micro ambient. All the operational parameters of the cell were investigated by planning specific assays. The results of these assays were in agreement with the criterions established and indicated the potential of the project in the development of a hot cell for radiopharmaceutical production.

We review the first generations of clinical trials of novel cell therapies applied to a range of neurodegenerative diseases in the context of mechanisms of functional efficacy. This in turn helps to determine the best strategies to be adopted and the potential chances for success in developing new cell therapies to clinical application in different conditions. We then consider the scientific, technical, ethical, regulatory and logistic issues to be resolved in translating effective laboratory cell-based protocols to patients in clinical trials. We draw optimistic conclusions about the likelihood of success in developing radical new approaches to a range of devastating, and currently untreatable, neurodegenerative conditions, but caution that the problems are complex and the solutions are likely to be slow and costly to achieve in order to overcome significant ethical and regulatory as well as scientific challenges.

The determination of the microbial load of a spacecraft en route to interesting extraterrestrial environments is mandatory and currently based on the culturable, heat-shock-surviving portion of microbial contaminants. Our study compared these classical bioburden measurements as required by NASA's and ESA's guidelines for the microbial examination of flight hardware, with molecular analysis methods (16S rRNA gene cloning and quantitative PCR) to further develop our understanding of the diversity and abundance of the microbial communities of spacecraft-associated clean rooms. Three samplings of the Herschel Space Observatory and its surrounding clean rooms were performed in two different European facilities. Molecular analyses detected a broad diversity of microbes typically found in the human microbiome with three bacterial genera (Staphylococcus, Propionibacterium, and Brevundimonas) common to all three locations. Bioburden measurements revealed a low, but heterogeneous, abundance of spore-forming and other heat-resistant microorganisms. Total cell numbers estimated by quantitative real-time PCR were typically 3 orders of magnitude greater than those determined by viable counts, which indicates a tendency for traditional methods to underestimate the extent of clean room bioburden. Furthermore, the molecular methods allowed the detection of a much broader diversity than traditional culture-based methods.

El objetivo del presente estudio técnico es la instalación de una lavadora de viales junto con un túnel de despirogenación con desembocadura en una sala blanca. Para ello, se especificaran las características y el funcionamiento general del equipo, además de los sistemas requeridos para la instalación, los conductos HVAC necesarios para las salas de fabricación estériles. Se estudiaran las presiones necesarias para cada sala de la zona estéril, así como los flujos de material, personal, materia prima, la instalación eléctrica, la iluminación y los puntos de servicio. Se estudiará en profundidad el sistema de climatización en dicha sala para garantizar una baja contaminación. Gracias a esta instalación, se mejorará la productividad, el tiempo de trabajo y la calidad de los productos.