Technical, Environmental, and Economic Analysis Comparing Low-Carbon Industrial Process Heat Options in U.S. Poly(vinyl chloride) and Ethylene Manufacturing Facilities.

Electrification and clean hydrogen are promising low-carbon options for decarbonizing industrial process heat, which is an essential target for reducing sector-wide emissions. However, industrial processes with heat demand vary significantly across industries in terms of temperature requirements, capacities, and equipment, making it challenging to determine applications for low-carbon technologies that are technically and economically feasible. In this analysis, we develop a framework for evaluating life cycle emissions, water use, and cost impacts of electric and clean hydrogen process heat technologies and apply it in several case studies for plastics and petrochemical manufacturing industries in the United States. Our results show that industrial heat pumps could reduce emissions by 12-17% in a typical poly(vinyl chloride) (PVC) facility in certain locations currently, compared to conventional natural gas combustion, and that other electric technologies in PVC and ethylene production could reduce emissions by nearly 90% with a sufficiently decarbonized electric grid. Life cycle water use increases significantly in all low-carbon technology cases. The levelized cost of heat of viable low-carbon technologies ranges from 15 to 100% higher than conventional heating systems, primarily due to energy costs. We discuss results in the context of relevant policies that could be useful to manufacturing facilities and policymakers for aiding the transition to low-carbon process heat technologies.

Analysis of Legacy and Novel Neutral Per- and Polyfluoroalkyl Substances in Soils from an Industrial Manufacturing Facility.

Per- and polyfluoroalkyl substances (PFASs) have been detected in an array of environmental media due to their ubiquitous use in industrial and consumer products as well as potential release from fluorochemical manufacturing facilities. During their manufacture, many fluorotelomer (FT) facilities rely on neutral intermediates in polymer production including the FT-alcohols (FTOHs). These PFAS are known to transform to the terminal acids (perfluoro carboxylic acids; PFCAs) at rates that vary with environmental conditions. In the current study on soils from a FT facility, we employed gas chromatography coupled with conventional- and high-resolution mass spectrometry (GC-MS and GC-HRMS) to investigate the profile of these precursor compounds, the intermediary secondary alcohols (sFTOHs), FT-acrylates (FTAcr), and FT-acetates (FTAce) in soils around the former FT-production facility. Of these precursors, the general trend in detection intensity was [FTOHs] > [sFTOHs] > [FTAcrs], while for the FTOHs, homologue intensities generally were [12:2 FTOH] > [14:2 FTOH] > [16:2 FTOH] > [10:2 FTOH] > [18:2 FTOH] > [20:2 FTOH] > [8:2 FTOH] ∼ [6:2 FTOH]. The corresponding terminal acids were also detected in all soil samples and positively correlated with the precursor concentrations. GC-HRMS confirmed the presence of industrial manufacturing byproducts such as FT-ethers and FT-esters and aided in the tentative identification of previously unreported dimers and other compounds. The application of GC-HRMS to the measurement and identification of precursor PFAS is in its infancy, but the methodologies described here will help refine its use in tentatively identifying these compounds in the environment.

Residential proximity to toxic metal-emitting industrial sites and toenail metal concentrations in a United States-wide prospective cohort.

BACKGROUND: Industrial facilities across the United States (US) release millions of pounds of toxic chemicals, including metals. Exposure to toxic metals has been associated with adverse health outcomes, but there is limited evidence on the association between living near metal-releasing facilities and the body burden of emitted compounds. OBJECTIVE: To investigate the association between residential proximity to toxic metal-emitting industrial facilities and toenail metal concentrations and to evaluate whether associations differed by race. METHODS: In a sample of 1556 non-Hispanic Black (32.5%) and non-Hispanic White (67.5%) women from the Sister Study, we used the US Environmental Protection Agency Toxics Release Inventory to identify metal-emitting facilities within 3, 5, and 10 km of participants' baseline residences. We measured toenail concentrations (µg/g) of arsenic, cadmium, cobalt, chromium, and lead. Using multivariable linear regression, we examined associations between residential proximity to and emissions from metal-emitting facilities and toenail metal concentrations, stratifying by race. We explored modification of race-stratified associations by neighborhood deprivation, using the Area Deprivation Index (ADI). RESULTS: Black participants were more likely to reside within 3 km of chromium-releasing facilities and 5 and 10 km of all observed metal-emitting sites. Living near metal-releasing facilities was not associated with higher toenail metal concentrations overall. Among Black women, higher chromium emissions exposure was associated with higher toenail chromium levels (ßTertile3vs.non-exposed = 2.36 µg/g, 95% CI = 0.63, 4.10). An association with lead was observed among Black women residing in the most deprived areas (≥75th ADI percentile: ß = 3.08 µg/g, 95% CI = 1.46, 4.71). No associations were observed for White participants. CONCLUSIONS: Despite low exposure prevalence, our findings suggest that living near chromium- and lead-releasing facilities, especially at shorter distances, may be associated with higher corresponding toenail metal levels among Black women, particularly those residing in the most disadvantaged areas.

Bacterial community and filamentous population of industrial wastewater treatment plants in Belgium.

The discharge of industrial water requires the removal of its pollutants, where biological wastewater treatment plants (WWTPs) are the most used systems. Biological WWTPs make use of activated sludge (AS), where bacteria are responsible for the removal of pollutants. However, our knowledge of the microbial communities of industrial plants is limited. Understanding the microbial population is essential to provide solutions to industrial problems such as bulking. The aim of this study was to identify at a high taxonomic resolution the bacterial population of 29 industrial WWTPs using 16S rRNA amplicon sequencing. Our results revealed that the main functional groups were dominated by Thauera and Zoogloea within denitrifiers, Dechloromonas in phosphate-accumulating organisms, and Defluviicoccus in glycogen-accumulating organisms. The activated sludge characterization indicated that 59% of the industrial plants suffered from bulking sludge, with DSVI values of up to 448 mL g-1. From the bulking cases, 72% corresponded to filamentous bulking with Thiothrix as the most abundant filament; meanwhile, the other 28% corresponded to viscous bulking sludge in which Zoogloea was the most abundant genus. Furthermore, the bacterial population did not share a core of taxa across all industrial plants. However, 20 genera were present in at least 50% of the plants comprising the general core, including Thauera, Ca. Competibacter, and several undescribed microorganisms. Moreover, statistical analysis revealed that wastewater salinity strongly affected the microbial richness of the industrial plants. The bacterial population across industrial plants differed considerably from each other, resulting in unique microbial communities that are attributed to the specificity of their wastewaters. KEY POINTS: • The general core taxa of industrial plants were mostly made up of undescribed bacterial genera. • Filamentous bacteria constituted on average 4.1% read abundance of the industrial WWTPs. • Viscous bulking remains a significant type of bulking within industrial WWTPs.

[Analysis of symptoms and influencing factors of low back work-related musculoskeletal disorders among workers in a container manufacturing factory].

Objective: To investigate the occurrence of low back work-related musculoskeletal disorders (WMSDs) among workers in a container manufacturing factory, and to explore the influencing factors. Methods: In June 2022, 952 workers from a container factory were selected as the research objects by cluster random sampling. Through questionnaire survey, the incidence of low back WMSDs symptoms among workers in the past one year was collected, and the influencing factors of low back WMSDs were analyzed by logistic regression. Results: The incidence rate of low back WMSDs was 46.7% (445/952). The factors with higher exposure at work were frequent slight bending (77.0%, 733/952), frequent overtime (74.1%, 705/952), and the need to turn around while working (62.3%, 593/952). Multivariate logistic regression analysis showed that age over 40 years old, smoking, drinking, often bending over slightly, sitting for a long time, maintaining a large bending posture for a long time, often working overtime, limited operating space, and there was always a need to complete conflicting things in the container manufacturing factory workers were the risks of increasing the low back WMSDs (OR=1.68, 1.96, 2.47, 1.49, 1.84, 2.11, 1.90, 1.82, 2.00, P<0.05). Standing at work, always friendly colleagues, and always supportive and helpful leaders were protective factors for low back WMSDs (OR=0.60, 0.32, 0.40, P<0.05) . Conclusion: The incidence of low back WMSDs symptoms in container manufacturing workers is high, and work-related factors such as frequent slight bending, long time holding large bending posture and limited operating space are the focus of ergonomic intervention in container manufacturing enterprises.

Plans to expand African vaccine production face steep hurdles.

Moderna's pause on Kenya project highlights difficulties in creating a competitive vaccine sector on the continent.

Case study of chemical and enzymatic degumming processes in soybean oil production at an industrial plant.

The vegetable oil degumming process plays a critical role in refining edible oil. Phospholipids (PL) removal from crude extracted soybean oil (SBO) by the enzymatic degumming process has been investigated in this work. Enzymatic degumming of extracted SBO with microbial phospholipase A1 PLA-1 Quara LowP and Lecitase Ultra enzymes have also been studied comparatively. The main novelty of our work is the use of the enzymatic degumming process on an industrial scale (600 tons a day). Many parameters have been discussed to understand in detail the factors affecting oil losses during the degumming process. The factors such as chemical conditioning (CC) by phosphoric acid 85%, the enzyme dosage mg/kg (feedstock dependent), the enzymatic degumming reaction time, and the characteristics of the plant-processed SBO have been discussed in detail. As a main point, the degummed oil with a phosphorus content of < 10 mg/kg increases yield. Quara LowP and Lecitase Ultra enzymes are not specific for certain phospholipids PL; however, the conversion rate depends on the SBO phospholipid composition. After 4 h, over 99% of Phospholipids were degraded to their lysophospholipid LPL (lysolecithin). The results showed a significant effect of operating parameters and characteristics of different origins of SBO, fatty acids FFA content, Phosphorus content and total divalent metals (Calcium Ca, Magnesium Mg and Iron Fe mg/kg) content on the oil loss. The benefit of using enzymatic degumming of vegetable oils rather than traditional chemical refining is that the enzymatic degumming process reduces total oil loss. This decrease is known as enzymatic yield. The enzymatic degumming also decreases wastewater and used chemicals and running costs; moreover, it enables physical refining by lowering the residue phosphorus to < 10 mg/kg.

Diagramas complejos de salud en el trabajo: metodología para el estudio sistémico de los procesos laborales / Complex diagrams of health in the workplace: A methodology for the systemic study of work processes

El estudio de los procesos de trabajo es una tarea «compleja¼ que incluye el conocimiento exhaustivo y preciso de los riesgos y exigencia laborales ahí presentes. Dichos riesgos y exigencias son el resultado de cómo se relacionan los elementos fundamentales del proceso laboral que, al interactuar con el hombre que trabaja, pueden afectar su salud. La finalidad de estas líneas es mostrar una metodología de carácter etnográfico, para investigar los procesos de trabajo en las entidades productivas y plantear las acciones preventivas conducentes. Esta metodología está basada en la observación directa y en la experiencia obrera de los procesos laborales. Consta de tres instrumentos de recolección de información: 1) Diagramas de Flujo del Proceso de trabajo; 2) Descripción de los Diagramas de Flujo de los Procesos de Trabajo; y 3) Cuadros de Resumen de los Diagramas Complejos de Salud en el Trabajo. A partir de los datos que proporcionan los Cuadros de Resumen, se estructura un repertorio de recomendaciones para el centro laboral. En cuanto a la utilidad de esta metodología, ha sido ampliamente probada en diversos sectores económicos, como: agricultura, industrias extractivas, de la transformación y la construcción, así como de los servicios, ya sean micro, pequeñas, medianas o grandes empresas. En síntesis, es una herramienta que proporciona el conocimiento integral de los procesos de trabajo, de los riesgos y exigencias que de ahí se derivan, y suministra las medidas preventivas para eliminar o controlar los peligros que acechan a los trabajadores en sus labores(AU)

The study of work processes is a complex task that includes exhaustive and precise knowledge of the labor demands and risks in a given workplace. These risks and demands result from the relationship among the fundamental elements of the work process, whose interaction with a worker can affect his health. The purpose of this study is to show how an ethnographic methodology was used to investigate work processes in productive industry workplaces and propose appropriate preventive actions. The methodology is based on direct observation and workers' experience of work processes. It consists of three data collection instruments: 1) Work process flow charts; 2) description of the flow diagrams of the work processes; and 3) summary tables of complex diagrams of workplace health. Based on the data provided in the summary tables, a set of recommendations for the workplace was designed. This methodology has been widely tested in various economic sectors, such as agriculture; extractive, transformative, and construction industries; and services, whether in micro, small, medium, or large companies. In summary, this is a tool that provides integrated knowledge about work processes and the risks and demands inherent in them and provides preventive measures to eliminate or control dangers to workers(AU)

Manejo y disposición de desechos sólidos en la zona industrial Lurigancho del Perú / Management and disposal of solid waste in the Lurigancho industrial zone of Peru

La presente nota científica plantea una propuesta para gestionar de manera integral el problema ocasionado por la mala disposición de los desechos sólidos en la zona industrial Lurigancho, Perú. Se basa en el modelo de operador, que considera la parte política, estratégica y regulador, de esta manera contar con indicadores, que sirvan de herramientas para la toma de decisiones en la en la gestión de residuos a las plantas industriales a partir de su control, vigilancia, información y clasificación. Esta propuesta se aplicó en doce lugares de disposición de los residuos industriales, puntos de monitoreo, con dos intervenciones, con la evaluación inicial se observó caos ambiental, con desbordamiento de los contenedores de basura, sin aprovechamiento de los residuos y proliferación de fauna nociva. Posterior a la inducción para ejecutar la propuesta, en la segunda intervención, posterior a 45 días, se precisó mejoras considerables, aplicándose recomendaciones objetivas basadas en los valores de los indicadores los que permitieron la planificación estratégica y operativa y de la programación y el control generales. Los resultados preliminares hacen suponer que esta propuesta atiende requerimientos medioambientales y de salubridad, a través de la reducción y procesamiento de los residuos, cuya inadecuada disposición puede llegar a afectar la salud humana(AU)

This scientific note presents a proposal to comprehensively manage the problem caused by poor disposal of solid waste in the Lurigancho industrial zone, Peru. It is based on the operator model, which considers the political, strategic and regulatory part, thus having indicators that serve as tools for decision-making in the management of waste at industrial plants based on its control. , surveillance, information and classification. This proposal was applied in twelve industrial waste disposal sites, monitoring points, with two interventions, with the initial evaluation environmental chaos was observed, with overflow of garbage containers, without use of waste and proliferation of harmful fauna. After the induction to execute the proposal, in the second intervention, after 45 days, considerable improvements were required, applying objective recommendations based on the values of the indicators, which allowed strategic and operational planning and general programming and control. . Preliminary results suggest that this proposal meets environmental and health requirements, through the reduction and processing of waste, whose inadequate disposal can affect human health(AU)

Saneamiento industrial: Biodisponibilidad de patógenos en superficies / Industrial sanitation: Bioavailability of pathogens on surfaces

En condiciones adecuadas como humedad, alcalinidad, o temperatura, determinados patógenos logran adherirse a las superficies y sobrevivir ciertos períodos fuera de un anfitrión, persistiendo en algunos casos a procesos deficientes de limpieza y desinfección, configurándose como un posible foco de transmisión. Por ello, el correcto saneamiento cumple un propósito vital en la protección de los trabajadores de la industria y otros sectores frente al riesgo de contaminación por contacto directo con las superficies contaminadas. La literatura científica muestra amplia evidencia de la supervivencia de patógenos sobre superficies que son habituales dentro de instalaciones industriales, como acero, aluminio, madera, plástico y vidrio. La supervivencia de microorganismos en las superficies puede configurarse como candidato a marcador de biodisponibilidad, que puede ser usado en la industria para establecer y auditar los planes de higienización y saneamiento industrial, permitiendo estudiar la eficacia de los compuestos usados en la desinfección, y variables como su concentración, temperatura, e intervalos de aplicación y remoción(AU)

Under suitable conditions such as humidity, alkalinity, or temperature, certain pathogens manage to adhere to surfaces and survive certain periods outside of a host, persisting in some cases to poor cleaning and disinfection processes, becoming a possible source of transmission. Therefore, proper sanitation serves a vital purpose in protecting workers in industry and other sectors from the risk of contamination by direct contact with contaminated surfaces. The scientific literature shows ample evidence of the survival of pathogens on surfaces that are common within industrial facilities, such as steel, aluminum, wood, plastic and glass. The survival of microorganisms on surfaces can be configured as a candidate for bioavailability marker, which can be used in the industry to establish and audit industrial sanitation and sanitation plans, allowing to study the efficacy of the compounds used in disinfection, and variables such as its concentration, temperature, and application and removal intervals(AU(

Higienización y eliminación fúngica en instalaciones industriales para la disminución de riesgos ocupacionales / Sanitization and fungal elimination in industrial facilities to reduce occupational risks

Se ha comprobado que la exposición a bioaerosoles se asocia con varios efectos sobre la salud, como enfermedades pulmonares y alergias. El presente estudio transversal tuvo como objetivo investigar la contaminación por hongos en varias superficies pertenecientes a dos industrias de alimentos. La toma de muestra se realizó en tres semanas, inmediatamente después de realizada la limpieza y desinfección y antes de iniciar la producción. Se recolectaron 400 muestras de superficie (vidrio, acero inoxidable, aluminio, goma y plástico), también se evaluó la eficacia del programa de higienización en el control de la población de hongos. Todas las muestras presentaron recuentos fúngicos <10 ufc/cm2, sin haber diferencias significativas entre los tipos de superficie, sin embargo, las superficies plásticas exhibieron mayor crecimiento logarítmico de los hongos. Se determinó que 49,60% de las especies identificadas correspondieron al género Penicillium. Aunque los niveles de hongos en las industrias estudiadas fueron inferiores a los niveles recomendados por la Organización Mundial de la Salud, algunas medidas de salud ambiental como lavar y desinfectar las superficies después de cada turno de trabajo, y se recomiendan inspecciones periódicas para garantizar la seguridad de los trabajadores y de los productos que allí se manufacturan(AU)

It has been proven that exposure to bioaerosols is associated with several health effects, such as pulmonary diseases and allergies. The present crosssectional study aimed to investigate fungal contamination on various surfaces belonging to two food industries. The sampling was carried out in three weeks, immediately after cleaning and disinfection and before starting production. 400 surface samples were collected (glass, stainless steel, aluminum, rubber and plastic), the effectiveness of the sanitation program in controlling the fungal population was also evaluated. All the samples presented fungal counts <10 cfu / cm2, with no significant differences between the types of surfaces, however, the plastic surfaces exhibited higher logarithmic growth of the fungi. It was determined that 49.60% of the identified species corresponded to the Penicillium genus.Although the levels of fungi in the studied baths were lower than the levels recommended by the World Health Organization, some environmental health measure ssuch as washing and disinfecting surfaces after each working shift and periodic inspections are recommended ensuring the safety of the workers and the products that are manufactured there(AU)

Biorreactores de un solo uso en la industria biofarmacéutica y su uso en la producción de candidatos vacunales contra SARS- COV-2. Artículo de revisión / Single-use systems bioreactors in the biopharmaceutical industry and its use in SARS-CoV-2 vaccine's candidates production. A review

Los biorreactores de sistemas de un solo uso (SUSs), también conocidos como biorreactores desechables, se han convertido en una parte integral de las instalaciones biotecnológicas de fabricación para bioproductos con un mercado potencial que espera una tasa de crecimiento de casi el 15,5% durante el período pronosticado: 2018 a 2023. Los biorreactores SUSs son más seguros, simples y flexibles al compararlos con sus contrapartes, biorreactores de acero inoxidable, por lo que su uso se está incrementando en la industria biofarmacéutica principalmente en la planificación de vías rápidas de proyectos complejos, incluidos los relacionados con la pandemia de SARS-CoV-2. Así, el uso de SUS se ha convertido en una alternativa eficaz para la producción rápida de candidatos a vacunas. Pero algunas desventajas técnicas y operativas aún obstaculizan su uso en todo el mundo. Esta revisión brinda una visión racional del uso, los tipos, los parámetros operativos y las nuevas aplicaciones de los biorreactores SUSs en la industria biofarmacéutica. Asimismo, también se discuten los parámetros apropiados y las limitaciones de este equipo, enfocándose en su uso para la producción de vacunas contra COVID-19

Single-Use-Systems (SUSs) Bioreactors, also known as disposable bioreactors, have become an integral part of biotechnology manufacturing facilities for bioproducts with a potential market expecting a growth rate of nearly 15.5% over the forecast period: 2018 to 2023. SUSs bioreactors are comparatively safe, simple, and flexible than their stainless-steel bioreactors counterparts thus, their usage is being augmented in the biopharmaceutical industry mainly in planning fast tracks of complex projects, including those related to the SARS-CoV-2 pandemic. Thus, the use of SUSs has become an effective alternative for the rapid production of vaccine candidates. However, some technical and operational disadvantages still hamper their worldwide use. This review gives a rational insight into SUSs bioreactors use, types, operational parameters and new applications in the biopharmaceutical industry. Likewise, the appropriate parameters and limitations of this equipment, focusing on its use for vaccine production against COVID-19 are also discussed

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.

Gestión del desarrollo de productos en el Centro de Inmunología Molecular / Product development management at Molecular Immunology Center

El crecimiento de las empresas en un mundo altamente competitivo depende del rendimiento superior del proceso de desarrollo de sus productos. Estudios anteriores mostraron que hoy la dificultad principal del crecimiento del Centro de Inmunología Molecular está en la capacidad de penetrar los mercados de exportación, y el desarrollo de nuevos productos. La implementación de un sistema de gestión de desarrollo de productos a partir del diagnóstico de las limitaciones actuales permitirá eliminar las restricciones en el desarrollo de nuevos productos y constituirá una herramienta para el éxito de la realización de los mismos de manera competitiva. En este artículo se caracteriza la gestión de desarrollo de productos en el Centro de Inmunología Molecular, a partir de la realización de encuestas y tormentas de ideas y se propone un sistema de gestión para el desarrollo de productos en la institución que permita su uso como herramienta para su competitiva realización(AU)

The growth of companies in a highly competitive world depends on the superior performance of the development process of their products. Previous studies showed that today the main difficulty of the Molecular Immunology Center growth resides in the ability to enter international markets, and in the development of new products. The implementation of a product development management system based on the diagnosis of the current limitations will eliminate the restrictions and will be a tool for successfully implementing competitive products at the center. The product development management in the Center of Molecular Immunology is characterized in this paper starting from surveys and brainstorming results; and a product development management system is proposed to the institution as a tool to create a sustainable competitive advantage for the new products(AU)

Establecimiento de límites microbiológicos internos para áreas clasificadas Grado D / Establishing internal microbiological limits for D grade-classified areas

Objetivo: contribuir al aseguramiento de la calidad microbiológica de una planta de producción de vacunas, a través del establecimiento de límites internos de alerta y de acción para sus áreas clasificadas Grado D. Métodos: se estudió la microbiota residente de cada área clasificada Grado D. Se analizaron muestras de aire tomadas por el método volumétrico. Las superficies e indumentaria del personal fueron evaluadas por el método de contacto. Los recuentos de microorganismos fueron analizados estadísticamente para la determinación de los límites de alerta y de acción. Resultados: se establecieron los límites de alerta y de acción microbiológicos para cada área clasificada Grado D de la planta de producción del Instituto Nacional de Enfermedades Virales Humanas basados en la determinación de los rangos habituales de trabajo. Se establecieron límites, como en el caso de guantes pos trabajo para un área Grado D, donde la norma no los define. Conclusiones: se mostró concordancia con los límites recomendados por la autoridad regulatoria nacional ANMAT y proporcionó información sobre la carga microbiológica de los ambientes clasificados Grado D, que será de utilidad tanto para la comprensión del ingreso y circulación de microorganismos como para la implementación de medidas para prevenir la contaminación microbiana, aspectos críticos en la fabricación de vacunas seguras, puras y eficaces(AU)

Objective: to contribute to ensuring the microbiological quality of a vaccine manufacturing plant through the establishment of internal microbiological alert and action limits for their grade D classified areas. Methods: the resident microbiota of each grade D classified area was studied. Air samples taken by the volumetric method were analyzed. The surfaces and the staff's gowning were evaluated by the contact method. The microorganism counts were statistically analyzed to determine the alert and action limits. Results: the microbiological alert and action limits have been established for each Grade D classified area of the production plant of the National Institute of Human Viral Diseases, based on the determination of the usual working ranges. Limits were set, as in the case of gloves after work for a Grade D area, where the standard does not define them. Conclusions: the results generally agreed with the limits recommended by the national regulatory authority ANMAT, and additionally, this study provided information on the microbiological flora of grade D classified environments, which will be useful for both understanding the entrance and circulation of microorganisms and implementing measures to prevent biocontamination, which are critical aspects in the manufacture of effective, pure and safe vaccines(AU)