Reverberation time recommendations for noisy industrial workshops.

Industrial workshops or any other industrial premises where noisy machines are operated should be as acoustically absorbent as possible. On the other hand, acoustic treatments are expensive (especially when correcting existing premises), messy, and not always compatible with the implemented production processes. Therefore, there is a need for acoustic specifications to find the best compromise between cost and efficiency. In France, for noisy industrial workshops to be compliant, the regulation requires the rate of decay of sound per distance doubling (DL2) to exceed compulsory limit values, unless this does not have a significant impact on workers' exposure to noise. However, that rate of decay is difficult and time consuming to evaluate. The purpose of this paper is to provide recommendations based on reverberation time (RT), which is not only easier to measure but is also widely used. The D2L values are conventionally measured in industrial workshops together with RT values and thus a database compiling both RT and DL2 values was available. It has been used to draw up reference limits for RT values consistent with the DL2 regulation limits. These reference limits were validated by comparison with the literature and with a new set of data collected specially for the purposes of performing that comparison. The final limits are divided into four categories: compliant/non-compliant, for furnished/empty industrial workshops, using a 95/99% confidence interval. They are intended to enable the acoustic treatment of a workshop to be evaluated using a simple metric, either at the design stage or for monitoring or occupational inspection purposes.

Fine-Grained Spatiotemporal Analysis of the Impact of Restricting Factories, Motor Vehicles, and Fireworks on Air Pollution.

Aiming at improving the air quality and protecting public health, policies such as restricting factories, motor vehicles, and fireworks have been widely implemented. However, fine-grained spatiotemporal analysis of these policies' effectiveness is lacking. This paper collected the hourly meteorological and PM2.5 data for three typical emission scenarios in Hubei, Beijing-Tianjin-Hebei (BTH), and Yangtze River Delta (YRD). Then, this study simulated the PM2.5 concentration under the same meteorological conditions and different emission scenarios based on a reliable hourly spatiotemporal random forest model (R2 exceeded 0.84). Finally, we investigated the fine-grained spatiotemporal impact of restricting factories, vehicles, and fireworks on PM2.5 concentrations from the perspective of hours, days, regions, and land uses, excluding meteorological interference. On average, restricting factories and vehicles reduced the PM2.5 concentration at 02:00, 08:00, 14:00, and 20:00 by 18.57, 16.22, 25.00, and 19.07 µg/m3, respectively. Spatially, it had the highest and quickest impact on Hubei, with a 27.05 µg/m3 decrease of PM2.5 concentration and 17 day lag to begin to show significant decline. This was followed by YRD, which experienced a 23.52 µg/m3 decrease on average and a 23 day lag. BTH was the least susceptible; the PM2.5 concentration decreased by only 8.2 µg/m3. In addition, influenced by intensive human activities, the cultivated, urban, and rural lands experienced a larger decrease in PM2.5 concentration. These empirical results revealed that restricting factories, vehicles, and fireworks is effective in alleviating air pollution and the effect showed significant spatiotemporal heterogeneity. The policymakers should further investigate influential factors of hourly PM2.5 concentrations, combining with local geographical and social environment, and implement more effective and targeted policies to improve local air quality, especially for BTH and the air quality at morning and night.

Cell and gene therapy manufacturing capabilities in Australia and New Zealand.

Cell and gene therapy products are rapidly being integrated into mainstream medicine. Developing global capability will facilitate broad access to these novel therapeutics. An initial step toward achieving this goal is to understand cell and gene therapy manufacturing capability in each region. We conducted an academic survey in 2018 to assess cell and gene therapy manufacturing capacity in Australia and New Zealand. We examined the following: the number and types of cell therapy manufacturing facilities; the number of projects, parallel processes and clinical trials; the types of products; and the manufacturing and quality staffing levels. It was found that Australia and New Zealand provide diverse facilities for cell therapy manufacturing, infrastructure and capability. Further investment and development will enable both countries to make important decisions to meet the growing need for cell and gene therapy and regenerative medicine in the region.

Avaliação das instalações físicas, a fim de prevenir a contaminação dos alimentos em Unidade de Alimentação e Nutrição industrial da zona oeste do Rio de Janeiro / Evaluation of the physical installations, in order to prevent from contamination of the foods in feeding unit and nutrition industrial of Rio de Janeiro's West Zone

O objetivo deste estudo foi elaborar um Check List para a verificação das Boas Práticas de Fabricação nas instalações físicas de uma UAN localizada na zona oeste do Rio de Janeiro, capaz de englobar pontos que necessitam de fiscalização, a fim de prevenir a contaminação biológica dos alimentos. A UAN analisada apresentava várias não conformidades nos itens avaliados, apresentando condições higiênico-sanitárias insatisfatórias para manipulação de alimentos. Este fato reforça a necessidade de mudanças urgentes e também de maior fiscalização dos órgãos competentes junto ao estabelecimento, no que diz respeito às Boas Práticas de Manipulação de Alimentos. Foram avaliados 45 itens, distribuídos em edificações e instalações (recebimento, armazenamento, pré preparo e preparo), assim como vestiários, instalações sanitárias, abastecimento de água e gás e demais áreas.

Proceedings of the first academic symposium on developing, qualifying and operating a cell and gene therapy manufacturing facility.

A significant portion of the more than 1000 candidate cell and gene therapy products currently under clinical investigation (clinicaltrials.gov) are born out of academic research centers affiliated with universities, hospitals and non-profit research institutions. Supporting these efforts are myriad academic clinical materials production facilities with more than 40 such facilities currently operational in the United States alone. In March 2018, Stanford University's Laboratory for Cell and Gene Therapy held a symposium with the leaders and staff of more than 25 similar facilities to discuss the collective experience in developing, qualifying and operating cell and gene therapy manufacturing facilities according to current Good Manufacturing Practices. Topics included facility design, construction, staffing and operations and compliance. Leaders from several institutions gave overviews of the history of development of the facilities and discussed challenges and opportunities they had experienced over the past 10-20 years of operations. Working sessions were also held to discuss specific aspects of Process Development, Manufacturing, Quality Systems, Regulatory Affairs and Business Development with all participants contributing to the discussions. We summarize here the findings of this inaugural meeting with an emphasis on best practices and suggested guidelines for operations.

[Excess deaths for haematological tumours in Falconara Marittima (Marche Region, Central Italy): short story from the epidemiological survey up to now]. / EPICHANGE/3. Eccesso di morti per tumori ematologici a Falconara Marittima: breve storia dall'indagine epidemiologica a oggi.

API is a company refining petroleum products located in Falconara Marittima (Ancona Province, Marche Region, Central Italy). Thanks to the pressure made by citizens' committees, which considered the plant as a risk source for the population residing in the surroundings municipalities, Marche Region as institution asked for an epidemiological survey. This survey found a significative excess in deaths for haematological tumours in women and in a sub-group of retired and elderly. The results were published in one report and two scientific journals, and were also presented during a public meeting. It was urgent to made public health intervention, which were called for, but up to now nothing has been done. Here, the reconstruction of this affair, from the start of the epidemiological survey up to the more recent development in terms of public health.

[The opponent you do not just imagine. The case of Falconara Marittima (Marche Region, Central Italy)]. / EPICHANGE/2. L'avversario che non ti aspetti. Il caso di Falconara Marittima.

Falconara Marittima (Marche Region, Central Italy) is declared to be an area at high risk of environmental crisis, due to the presence of a refinery plant. In 2004, Marche Region funded an epidemiological survey to assess atmospheric risks linked to the refinery. This survey was conducted by the Italian National Cancer Institute of Milan, and citizens actively contributed. An excess for leukaemias and an increase in non-Hodgkin lymphomas were showed. These results were confirmed also by the Regional Environmental Protection Agency and the Regional Health Authority. But Marche Region and the Municipalities chose to not report the situation: the same Institutions, which at the beginning sided the citizens, became an opponent for health protection.

U.S. Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs.

Interest in the use of bacteria-containing products for the treatment or prevention of disease has increased in recent years. Bacterial preparations for human consumption are commercially available in the form of dietary supplements and typically contain strains with a history of use in food fermentation. Advances in our understanding of the role of the microbiota in health and disease are likely to lead to development of products containing more novel bacterial species, along with genetic modification of strains to provide specific functions. By law, any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans meets the definition of a drug, and an Investigational New Drug (IND) application for clinical investigation must be filed with the FDA. This article is meant to provide information about the IND submission process and additional considerations with regard to chemistry, manufacturing, and controls information for live biotherapeutic products.

Optimal multi-floor plant layout based on the mathematical programming and particle swarm optimization.

In the fields of researches associated with plant layout optimization, the main goal is to minimize the costs of pipelines and pumping between connecting equipment under various constraints. However, what is the lacking of considerations in previous researches is to transform various heuristics or safety regulations into mathematical equations. For example, proper safety distances between equipments have to be complied for preventing dangerous accidents on a complex plant. Moreover, most researches have handled single-floor plant. However, many multi-floor plants have been constructed for the last decade. Therefore, the proper algorithm handling various regulations and multi-floor plant should be developed. In this study, the Mixed Integer Non-Linear Programming (MINLP) problem including safety distances, maintenance spaces, etc. is suggested based on mathematical equations. The objective function is a summation of pipeline and pumping costs. Also, various safety and maintenance issues are transformed into inequality or equality constraints. However, it is really hard to solve this problem due to complex nonlinear constraints. Thus, it is impossible to use conventional MINLP solvers using derivatives of equations. In this study, the Particle Swarm Optimization (PSO) technique is employed. The ethylene oxide plant is illustrated to verify the efficacy of this study.