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2.
Environ Pollut ; 260: 113946, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32041007

RESUMO

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs) are cancerogenic organic pollutants that priority controlled by Stockholm Convention with globally 183 signatories now. Secondary nonferrous smelting plants are confirmed to be important sources in China due to its large industrial activities and high emissions of PCDD/Fs. It is important to prioritize source to achieve source emission reduction by conducting field monitoring on typical case plants. Here, the emission profiles and levels of PCDD/Fs were investigated in 25 stack gas samples collected from three secondary copper production (SeCu), two secondary zinc production (SeZn) and two secondary lead production (SePb). Both average mass concentration and toxic equivalency quantity (TEQ) concentrations of PCDD/Fs all generally decreased in the order: SeCu > SeZn > SePb. It is noteworthy that the mean TEQ concentration in stack gas from SeCu with oxygen-enrich melting furnace technology, at 2.7 ng I-TEQ/Nm3, was much higher than the concentrations of other smelting processes. The average emission factors and annual release amounts of PCDD/Fs from SeCu, SePb and SeZn investigated were 28.4, 1.5, 10.4 µg I-TEQ/t and 1.03, 0.023, 0.17 g I-TEQ/year, respectively. The ratios of 2,3,7,8-TCDF to 1,2,3,7,8-PeCDF and OCDD to 1,2,3,7,8,9-HxCDD varied to large extent for three metal smelting, which could be used as diagnostic ratios of tracing specific PCDD/Fs sources. Addition of copper-containing sludge into the raw materials might lead to higher PCDD/Fs emissions. It is important to emphasize and reduce the PCDD/Fs emissions from oxygen-enrich melting furnace from secondary copper productions.


Assuntos
Poluentes Atmosféricos , Dibenzofuranos Policlorados , Monitoramento Ambiental , Instalações Industriais e de Manufatura , Dibenzodioxinas Policloradas , Poluentes Atmosféricos/análise , China , Dibenzofuranos Policlorados/análise , Instalações Industriais e de Manufatura/normas , Dibenzodioxinas Policloradas/análise
3.
Artigo em Inglês | MEDLINE | ID: mdl-32033436

RESUMO

With the increasingly serious problem of environmental pollution, reducing carbon emissions has become an urgent task for all countries. The cap-and-trade (C&T) policy has gained international recognition and has been adopted by several countries. In this paper, considering the uncertainty of market demand, we discuss the carbon emission reduction and price policies of two risk-averse competitive manufacturers under the C&T policy. The two manufacturers have two competitive behaviors: simultaneous decision making and sequential decision making. Two models were constructed for these behaviors. The optimal decisions, carbon emission reduction rate, and price were obtained from these two models. Furthermore, in this paper the effects of some key parameters on the optimal decision are discussed, and some managerial insights are obtained. The results show that the lower the manufacturers' risk aversion level is, the higher their carbon emission reduction rate and utilities. As the carbon quota increases, the manufacturers' optimal carbon reduction rate and utilities increase. Considering consumers' environmental awareness, it is more beneficial for the government to reduce the carbon quota and motivate manufacturers' internal enthusiasm for emission reduction. The government can, through macro control of the market, make carbon trading prices increase appropriately and encourage manufacturers to reduce carbon emissions.


Assuntos
Tomada de Decisões , Política Ambiental , Poluição Ambiental/legislação & jurisprudência , Poluição Ambiental/prevenção & controle , Instalações Industriais e de Manufatura/economia , Instalações Industriais e de Manufatura/normas , Fatores de Risco
4.
J Appl Microbiol ; 127(6): 1901-1906, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31502742

RESUMO

AIMS: Salmonella contamination in the manufacturing process of an overseas oilmeal plant was investigated and countermeasures for Salmonella contamination were evaluated. METHODS AND RESULTS: Salmonella was detected from deposits and adhered materials inside the main processing equipment. Specifically high contamination was observed in the equipment associated with the meal cooler, with several Salmonella serovars being detected. A number of Salmonella serovars were also detected in the equipment of the fine powder recovery process. To prevent Salmonella contamination of oilmeal products, effective countermeasures that have been employed in Japan were implemented. By removing residues from the equipment and disinfecting the interior of the equipment, a significant decrease in the contamination rate of oilmeal products was achieved compared to before sanitation (P < 0·05). CONCLUSIONS: Effective countermeasures to control Salmonella contamination in the overseas manufacturing process of oilmeal were established. SIGNIFICANCE AND IMPACT OF THE STUDY: This is the first report focusing on Salmonella countermeasures in an actual oilmeal-manufacturing plant overseas.


Assuntos
Desinfecção/métodos , Contaminação de Equipamentos , Contaminação de Alimentos/prevenção & controle , Indústria de Processamento de Alimentos/métodos , Indústria de Processamento de Alimentos/normas , Instalações Industriais e de Manufatura/normas , Salmonella/isolamento & purificação , Contaminação de Equipamentos/prevenção & controle , Indústria de Processamento de Alimentos/instrumentação , Índia , Salmonella/genética , Saneamento
5.
Cytotherapy ; 21(10): 1081-1093, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31445816

RESUMO

BACKGROUND AIMS: Autologous cell therapy (AuCT) is an emerging therapeutic treatment that is undergoing transformation from laboratory- to industry-scale manufacturing with recent regulatory approvals. Various challenges facing the complex AuCT manufacturing and supply chain process hinder the scale out and broader application of this highly potent treatment. METHODS: We present a multiscale logistics simulation framework, AuCT-Sim, that integrates novel supply chain system modeling algorithms, methods, and tools. AuCT-Sim includes a single facility model and a system-wide network model. Unique challenges of the AuCT industry are analyzed and addressed in AuCT-Sim. Decision-supporting tools can be developed based on this framework to explore "what-if" manufacturing and supply chain scenarios of importance to various cell therapy stakeholder groups. RESULTS: Two case studies demonstrate the decision-supporting capability of AuCT-Sim where one investigates the optimal reagent base stocking level, and the other one simulates a reagent supply disruption event. These case studies serve as guidelines for designing computational experiments with AuCT-Sim to solve specific problems in AuCT manufacturing and supply chain. DISCUSSION: This simulation framework will be useful in understanding the impact of possible manufacturing and supply chain strategies, policies, regulations, and standards informing strategies to increase patient access to AuCT.


Assuntos
Algoritmos , Terapia Baseada em Transplante de Células e Tecidos , Simulação por Computador , Indústria Farmacêutica , Manufaturas/provisão & distribução , Instalações Industriais e de Manufatura , Terapia Baseada em Transplante de Células e Tecidos/economia , Terapia Baseada em Transplante de Células e Tecidos/métodos , Terapia Baseada em Transplante de Células e Tecidos/normas , Terapia Baseada em Transplante de Células e Tecidos/estatística & dados numéricos , Comércio , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Indústria Farmacêutica/estatística & dados numéricos , Utilização de Equipamentos e Suprimentos/estatística & dados numéricos , Humanos , Manufaturas/economia , Manufaturas/estatística & dados numéricos , Instalações Industriais e de Manufatura/economia , Instalações Industriais e de Manufatura/normas , Instalações Industriais e de Manufatura/estatística & dados numéricos , Instalações Industriais e de Manufatura/provisão & distribução , Controle de Qualidade , Indicadores de Qualidade em Assistência à Saúde , Transplante Autólogo , Estados Unidos/epidemiologia
6.
Work ; 62(2): 197-203, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30829631

RESUMO

BACKGROUND: Despite ergonomic improvements in the workplace of automobile parts manufacturing industry, many jobs still require workers to perform repetitive tasks or manual material handling. OBJECTIVE: This study compares the characteristics of occupational injuries between MMH and non-MMH in the automobile parts manufacturing industry based in South Korea and the US. METHODS: Occupational injuries were analyzed by age, work experience, company size, employment type, injury severity, work type, type of accident, agency of accident, injured part of body, and injury type. RESULTS: Among 1,530 injuries, 271 people (17.7%) were MMH injuries, and 1,259 people (82.3%) were non-MMH injuries. The rate of MMH injury was higher in the logistics process, in the work experience with more than 10 years, and in the company size with more than 100 employees than that of the non-MMH injury. Also, the rate of MMH injury was higher in the types of sprain and herniated discs, and in the injured part of trunk/back, leg/foot, and shoulder than that of the non-MMH injury. CONCLUSIONS: The results of this study can be used as essential data for establishing a systematic preventive policy for industrial accidents in the automobile parts manufacturing industry.


Assuntos
Acidentes de Trabalho/estatística & dados numéricos , Automóveis , Instalações Industriais e de Manufatura/normas , Teste de Materiais/métodos , Adulto , Ergonomia/métodos , Feminino , Humanos , Masculino , Instalações Industriais e de Manufatura/estatística & dados numéricos , Pessoa de Meia-Idade , República da Coreia , Estados Unidos , Local de Trabalho/normas
7.
Cytotherapy ; 21(3): 327-340, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30685216

RESUMO

Clinical trials of adoptively transferred CD19 chimeric antigen receptor (CAR) T cells have delivered unprecedented responses in patients with relapsed refractory B-cell malignancy. These results have prompted Food and Drug Administration (FDA) approval of two CAR T-cell products in this high-risk patient population. The widening range of indications for CAR T-cell therapy and increasing patient numbers present a significant logistical challenge to manufacturers aiming for reproducible delivery systems for high-quality clinical CAR T-cell products. This review discusses current and novel CAR T-cell processing methodologies and the quality control systems needed to meet the increasing clinical demand for these exciting new therapies.


Assuntos
Imunoterapia Adotiva/métodos , Instalações Industriais e de Manufatura/normas , Neoplasias/terapia , Controle de Qualidade , Receptores de Antígenos Quiméricos , Antígenos CD19/imunologia , Remoção de Componentes Sanguíneos/métodos , Sobrevivência Celular , Criopreservação/métodos , Endotoxinas/análise , Humanos , Imunoterapia Adotiva/efeitos adversos , Ativação Linfocitária , Mycoplasma , Linfócitos T/imunologia , Transdução Genética/métodos
8.
Artigo em Inglês | MEDLINE | ID: mdl-30679877

RESUMO

Background: The occurrence of occupational accidents is a serious public health issue in industrial workers and may impose life jeopardizing complications. The aim of the study was to assess the effect of a training intervention based on the theory of planned behavior (TPB) on helmet use of workers in cement factories in Khoy and Urmia, Northwest of Iran. Materials and methods: This study was a controlled quasi-experimental investigation (before and after) which was conducted on 170 workers employed in Khoy and Urmia cement factories, Northwest of Iran. Eighty-five eligible subjects from Khoy (as intervention group) and 85 similar samples from Urmia (as control group) were selected and recruited. A valid and reliable four-part questionnaire was used to collect the data including socio demographic information, awareness, the theory constructs, and the behavior. After completing the study questionnaire and needs assessment, a specific educational program was implemented on the intervention group only. The effects of education were compared between the groups before and after intervention. The posttest was applied 1 month after educational intervention. Results: The mean age of workers in the intervention and control groups was 34.32 ± 8.19 and 33.62 ± 6.17 years, respectively. Before education, the mean score of awareness and helmet use behavior of intervention group was 6.15 ± 3.4 and 5.35 ± 2.8, but after education, those changed into 13.61 ± 3.10 and 9.15 ± 1.65, and the differences were significant (p < 0.01). In addition, before education, the mean score of attitude, subjective norm, behavioral control, and behavioral intention of intervention group was 27 ± 5.17, 37.74 ± 6.92, 29.56 ± 6.17, and 17.65 ± 4.90, respectively. After education, the mean score of those changed into 37.26 ± 4.76, 48.34 ± 5.64, 42 ± 8.07, and 24.79 ± 5.33, respectively, and changes were statistically significant (p < 0.01), while no statistically significant differences were observed in awareness, the behavior, and the theory constructs in the control group after the intervention. Conclusion and recommendations: The TPB-based educational approach had a remarkable effect on helmet use of workers. Applying this theory to improve workers' personal protective behaviors is recommended and emphasized.


Assuntos
Acidentes de Trabalho/prevenção & controle , Dispositivos de Proteção da Cabeça/normas , Educação em Saúde/métodos , Instalações Industriais e de Manufatura/normas , Gestão da Segurança/normas , Adulto , Feminino , Humanos , Irã (Geográfico) , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Adulto Jovem
9.
Int J Food Microbiol ; 289: 64-71, 2019 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-30199737

RESUMO

The presence and colonization of Listeria monocytogenes were investigated in a newly established dairy processing plant during a one-year period. A total of 250 non-food contact surfaces, 163 food contact surfaces, 46 personnel and 77 food samples were analyzed in two different buildings according to the cheese production chain. Initial steps, including salting, are performed in building I (old facility), while the final steps, including ripening, cutting and packaging, are performed in building II (new facility). Overall, 218 samples were collected from building I and 318 from building II. L. monocytogenes isolates were subtyped by PFGE and MLST, and a questionnaire about quality measures was completed. The overall prevalence of L. monocytogenes was 8.40%, and while the presence of the pathogen was observed just during the first sampling in building I, L. monocytogenes was found in building II at the third sampling event. The salting area in building I had the highest proportion of positive samples with the highest diversity of PFGE types. Moreover, L. monocytogenes PFGE type 3 (sequence type -ST- 204) was first detected in building II in the third visit, and spread through this building until the end of the study. The answers to the questionnaire implied that lack of hygienic barriers in specific parts of the facilities and uncontrolled personnel flow were the critical factors for the spread of L. monocytogenes within and between buildings. Knowledge of the patterns of L. monocytogenes colonization can help a more rational design of new cheesemaking facilities, and improve the food safety within current facilities.


Assuntos
Queijo , Indústria de Laticínios , Manipulação de Alimentos/normas , Microbiologia de Alimentos , Listeria monocytogenes/crescimento & desenvolvimento , Instalações Industriais e de Manufatura/normas , Contaminação de Alimentos/análise , Inocuidade dos Alimentos , Listeria monocytogenes/genética , Tipagem de Sequências Multilocus , Inquéritos e Questionários
10.
Int J Occup Environ Health ; 24(3-4): 119-125, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30222068

RESUMO

OBJECTIVE: This study provides an assessment of heat stress in indoor rice vermicelli manufacturing factories. METHODS: Worker interviews and heat stress assessments were conducted in food manufacturing factories in Singapore. The Wet Bulb Globe Temperature (WBGT) and Heat Stress Index (HSI) were used as heat stress indicators. RESULTS: The highest WBGT and HSI levels recorded in the rice vermicelli manufacturing factories were 36.68°C and 3777 in the drying and steaming process respectively. These levels were above the recommended permissible HSI and WBGT action limit for heat exposure and considered to be high risk. CONCLUSION: Workers in indoor rice vermicelli manufacturing factories can be exposed to heat stress, and the current measures in place may not be sufficient to protect workers against heat stress injuries. Preventive measures such as engineering controls and heat acclimatization programs are important.


Assuntos
Indústria de Processamento de Alimentos , Transtornos de Estresse por Calor/epidemiologia , Resposta ao Choque Térmico , Instalações Industriais e de Manufatura , Doenças Profissionais/epidemiologia , Oryza , Indústria de Processamento de Alimentos/normas , Temperatura Alta/efeitos adversos , Humanos , Instalações Industriais e de Manufatura/normas , Exposição Ocupacional/efeitos adversos , Exposição Ocupacional/normas , Singapura/epidemiologia
11.
Transfusion ; 58(10): 2374-2382, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30203447

RESUMO

BACKGROUND: Expanding quantities of mesenchymal stem cells (MSCs) sufficient to treat large numbers of patients in cellular therapy and regenerative medicine clinical trials is an ongoing challenge for cell manufacturing facilities. STUDY DESIGN AND METHODS: We evaluated options for scaling up large quantities of bone marrow-derived MSCs (BM-MSCs) using methods that can be performed in compliance with Good Manufacturing Practices (GMP). We expanded BM-MSCs from fresh marrow aspirate in αMEM supplemented with 5% human platelet lysate using both an automated cell expansion system (Quantum, Terumo BCT) and a manual flask-based method using multilayer flasks. We compared MSCs expanded using both methods and assessed their differentiation to adipogenic and osteogenic tissue, capacity to suppress T-cell proliferation, cytokines, and growth factor secretion profile and cost-effectiveness of manufacturing enough BM-MSCs to administer a single dose of 100 × 106 cells per subject in a clinical trial of 100 subjects. RESULTS: We have established that large quantities of clinical-grade BM-MSCs manufactured with an automated hollow-fiber bioreactor were phenotypically (CD73, CD90, CD105) and functionally (adipogenic and osteogenic differentiation and cytokine and growth factor secretion) similar to manually expanded BM-MSCs. In addition, MSC manufacturing costs significantly less and required less time and effort when using the Quantum automated cell expansion system over the manual multilayer flasks method. CONCLUSION: MSCs manufactured by an automated bioreactor are physically and functionally equivalent to the MSCs manufactured by the manual flask method and have met the standards required for clinical application.


Assuntos
Reatores Biológicos/normas , Técnicas de Cultura de Células/métodos , Instalações Industriais e de Manufatura/normas , Células-Tronco Mesenquimais/citologia , Automação , Reatores Biológicos/economia , Células da Medula Óssea/citologia , Técnicas de Cultura de Células/normas , Proliferação de Células , Análise Custo-Benefício , Humanos
12.
Work ; 59(4): 557-570, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29733049

RESUMO

BACKGROUND: Previous research has shown that today's crane cabins fail to meet the needs of a large proportion of operators. Performance and financial losses and effects on safety should not be overlooked as well. OBJECTIVE: The first aim of this survey is to model the crane cabin interior space using up-to-date crane operator anthropometric data and to compare the multivariate and univariate method anthropometric models. The second aim of the paper is to define the crane cabin interior space dimensions that enable anthropometric convenience. METHODS: To facilitate the cabin design, the anthropometric dimensions of 64 crane operators in the first sample and 19 more in the second sample were collected in Serbia. The multivariate anthropometric models, spanning 95% of the population on the basis of a set of 8 anthropometric dimensions, have been developed. The percentile method was also used on the same set of data. RESULTS: The dimensions of the interior space, necessary for the accommodation of the crane operator, are 1174×1080×1865 mm. The percentiles results for the 5th and 95th model are within the obtained dimensions. CONCLUSIONS: The results of this study may prove useful to crane cabin designers in eliminating anthropometric inconsistencies and improving the health of operators, but can also aid in improving the safety, performance and financial results of the companies where crane cabins operate.


Assuntos
Antropometria/métodos , Desenho de Equipamento/normas , Ergonomia/métodos , Instalações Industriais e de Manufatura/normas , Antropometria/instrumentação , Humanos , Instalações Industriais e de Manufatura/estatística & dados numéricos , Análise Multivariada , Sérvia , Inquéritos e Questionários
14.
Pharm Dev Technol ; 23(3): 225-230, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28361586

RESUMO

Limits for the carry-over of product residues should be based on toxicological evaluation such as described in the "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities". The toxicological evaluation should be performed also for locally administered drugs to ensure patient safety. Currently, there is no guidance on setting PDE for ocular drug substances in particular. The purpose of this investigation was to identify and describe a method for calculating a PDE value for topical ocular drugs (PDEocular). As an alternative method, extrapolation of a PDE for systemically administered drugs to a PDEocular is presented. These methods may be applied in cross-contamination risk assessments for manufacturing of topical ocular drugs. Similarly, the methods apply to systemically administered drugs, if their production precedes manufacturing of a topical ocular drug. We have examined pharmacokinetic (PK) properties of topical ocular drugs and compared them to the PK parameters of systemically administered drugs. Furthermore, we examined possible adverse effects of the carry-over in topical ocular drugs at therapeutic doses.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica/normas , Instalações Industriais e de Manufatura/normas , Soluções Oftálmicas/efeitos adversos , Soluções Oftálmicas/normas , Relação Dose-Resposta a Droga , Olho/efeitos dos fármacos , Humanos , Medição de Risco
15.
Pharm Dev Technol ; 23(3): 261-264, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28535123

RESUMO

Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal. The therewith determined PDE otic, is used for the calculation of maximum safe carry-over (MSC) in manufacturing scenarios where a topical otic product is manufactured followed by another topical otic product.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Instalações Industriais e de Manufatura/normas , Preparações Farmacêuticas/normas , Relação Dose-Resposta a Droga , Indústria Farmacêutica/normas , Orelha , Humanos , Medição de Risco
16.
Ann Allergy Asthma Immunol ; 119(2): 101-107, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28801015

RESUMO

OBJECTIVE: To review the manufacturing procedures of food allergen extracts and applicable regulatory requirements from government agencies, potential approaches to standardization, and clinical application of these products. The effects of thermal processing on allergenicity of common food allergens are also considered. DATA SOURCES: A broad literature review was conducted on the natural history of food allergy, the manufacture of allergen extracts, and the allergenicity of heated food. Regulations, guidance documents, and pharmacopoeias related to food allergen extracts from the United States and Europe were also reviewed. STUDY SELECTIONS: Authoritative and peer-reviewed research articles relevant to the topic were chosen for review. Selected regulations and guidance documents are current and relevant to food allergen extracts. RESULTS: Preparation of a food allergen extract may require careful selection and identification of source materials, grinding, defatting, extraction, clarification, sterilization, and product testing. Although extractions for all products licensed in the United States are performed using raw source materials, many foods are not consumed in their raw form. Heating foods may change their allergenicity, and doing so before extraction may change their allergenicity and the composition of the final product. CONCLUSION: The manufacture of food allergen extracts requires many considerations to achieve the maximal quality of the final product. Allergen extracts for a select number of foods may be inconsistent between manufacturers or unreliable in a clinical setting, indicating a potential area for future improvement.


Assuntos
Alérgenos/metabolismo , Alérgenos/uso terapêutico , Dessensibilização Imunológica/métodos , Hipersensibilidade Alimentar/diagnóstico , Hipersensibilidade Alimentar/terapia , Alérgenos/imunologia , Reações Cruzadas/imunologia , Hipersensibilidade Alimentar/imunologia , Temperatura Alta , Humanos , Instalações Industriais e de Manufatura/normas
17.
Vaccimonitor (La Habana, Print) ; 26(2)may.-ago. 2017. ilus, tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1094590

RESUMO

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)


Assuntos
Produtos Biológicos , Biofarmácia , Instalações Industriais e de Manufatura/normas , Desenvolvimento de Medicamentos/normas
19.
Int J Occup Saf Ergon ; 23(1): 83-91, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27232423

RESUMO

This article provides relevant results of a cleaner production program conducted in a company dedicated to remanufacturing air compressors in the city of Hermosillo, Sonora, Mexico. The overall study design was based on an integration of acknowledged cleaner production and pollution prevention programs. Although this kind of program also involves environmental issues, this study focused on occupational health and safety by addressing different aspects of the work environment: ergonomic, physical (noise and lighting), and chemical. Particularly, ergonomic aspects were evaluated through the Modular Arrangement of Predetermined Time Standards (MODAPTS) method. For physical aspects, noise and lighting were addressed through Standard No. NOM-011-STPS-2001 and Standard No. NOM-025-STPS-2008 respectively. In addition, chemical aspects were analyzed through material safety data sheets and different search tools. Root causes of each risk were identified, and options to prevent, eliminate, and/or reduce each risk have been provided.


Assuntos
Ergonomia , Exposição Ocupacional/prevenção & controle , Saúde do Trabalhador , Poluição do Ar em Ambientes Fechados/prevenção & controle , Substâncias Perigosas , Humanos , Iluminação , Instalações Industriais e de Manufatura/normas , México , Ruído Ocupacional/prevenção & controle
20.
J Am Pharm Assoc (2003) ; 56(2): 201-2, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27000171

RESUMO

OBJECTIVES: Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ). SUMMARY: This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight. CONCLUSION: With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems.


Assuntos
Preparações Farmacêuticas/normas , Controle de Qualidade , United States Food and Drug Administration/organização & administração , Humanos , Instalações Industriais e de Manufatura/normas , Segurança do Paciente , Vigilância de Produtos Comercializados/normas , Estados Unidos
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