Solutions based on three-dimensional technologies for the practice and teaching of biomedical sciences

Introduction: Three-dimensional printing is one of the technologies that promote change at an economic and social level, and one of the fundamental elements of industry 4.0. It has enormous potential for the future of medicine, establishing itself as a new paradigm. Despite its advantages, its use in our environment is incipient. Objective: To design and develop solutions based on three-dimensional technologies for the teaching and practice of biomedical sciences. Materials and methods: A technological development investigation was carried out between the Center for Assisted and Sustainable Manufacturing of the University of Matanzas and Matanzas University of Medical Sciences, between September 2019 and July 2022. The designs and fabrications were made from the acquisition of computed tomography images, or from a surface scanner, which were then processed, converted into Standard Tessellation Language format, printed, and post-processed. Virtual designs were developed using computer-aided design software. Results: Various solutions were developed including prototypes: biomodels for craniosynostosis repair and anatomical figures, custom cranial prosthesis mold, hand prosthesis, O2 line splitters, tissue scaffolds, syringe gun, face shields, breast prosthesis; autologous restoration mold and tissue expander. Conclusions: In all areas of application of this technology in medicine―except the printing of medicines, in the current context―, it is feasible to obtain solutions in the territory of Matanzas. It is therefore imperative that managers and the medical community in general, begin to acquire awareness, knowledge, and experience to ensure the optimal use of this technology.

Introducción: La impresión tridimensional es una de las tecnologías que promueve el cambio a nivel económico y social, y uno de los elementos fundamentales de la industria 4.0. Asimismo, constituye un enorme potencial para el futuro de la medicina, estableciéndose como un nuevo paradigma. A pesar de sus ventajas, su explotación en nuestro medio es incipiente. Objetivos: Diseñar y desarrollar soluciones basadas en tecnologías tridimensionales para la enseñanza y la práctica de las ciencias biomédicas. Materiales y métodos: Se realizó una investigación colaborativa, de desarrollo tecnológico entre el Centro de Fabricación Asistida y Sostenible de la Universidad de Matanzas y la Universidad de Ciencias Médicas de Matanzas, entre septiembre de 2019 y julio de 2022. Los diseños y fabricaciones se realizaron a partir de la adquisición de imágenes de tomografía computarizada, o desde un escáner de superficie, las que luego se procesaron, se convirtieron en formato Standard Tessellation Language, se imprimieron y posprocesaron. Los diseños virtuales se desarrollaron empleando un software de diseño asistido por computadora. Resultados: Se desarrollaron varias soluciones que incluyen varios prototipos: biomodelos para reparación de craneosinostosis y figuras anatómicas, molde de prótesis craneal personalizada, prótesis de mano, divisores de líneas de O2, andamios tisulares, pistola portajeringas, protectores faciales, prótesis de mama, molde para restauración autóloga y expansor tisular. Conclusiones: En todas las áreas de aplicación de esta tecnología en medicina―salvo en la impresión de medicamentos, en el contexto actual―, es factible obtener soluciones en el territorio de Matanzas. Es un imperativo, pues, que directivos y la comunidad médica en general, comiencen a adquirir conciencia, conocimientos y experiencias para garantizar la utilización óptima de esta tecnología.

Reflections on intelligent transformation of biomedicine industry / 中国生物制品学杂志

@#The biomedicine industry is a strategic emerging industry that is related to the national economy,people's livelihood,and national security. As a new generation of digital production technology,the intelligent manufacturing of biopharmaceuticals has been proposed by policies such as the“14th Five Year Plan”for the development of the bioeconomy,and has become an important direction for the transformation and upgrading of the biopharmaceutical industry. This paper started with the background and significance of studying the intelligent transformation of the biopharmaceutical industry,analyzed the goals of the intelligent transformation of biopharmaceutical enterprises,and proposed relevant countermeasures and suggestions to accelerate the promotion of high-end intelligent transformation of the domestic biopharmaceutical industry.

Microtensile bond strength of resin cements to 3-D printed and milled temporary restorative resins / Resistencia de unión en microtracción de cementos resinosos a resinas para provisionales impresas y fresadas

Abstract To evaluate the microtensile bond strength (µTBS) of two resin cements to 3D printed and milled CAD/CAM resins used for provisional fixed partial dentures. Blocks (5 x 5 x 5 mm) of three 3D-printed resins (Cosmos3DTemp / Yller; Resilab3D Temp / Wilcos and SmartPrint BioTemp, / MMTech) were printed (Photon, Anycubic Technology Co.). A milled material (VitaCAD-Temp, VITA) was used as control. Half the specimens were sandblasted and the rest were untreated. Two blocks were bonded with the corresponding resin cement: PanaviaV5 (Kuraray Noritake) and RelyX Ultimate (3M Oral Care). After 24 hours, the bonded blocks were sectioned into 1 x 1 mm side sticks. Half the beams were tested for µTBS and the other half was thermocycled (5000 cycles, 30s dwell-time, 5s transfer time) before µTBS testing. A four way Generalized Linear Model (material*sandblasting*cement*aging) analysis was applied. VITA exhibited the lowest µTBS, regardless of the cement, sandblasting and thermocycling. Sandblasting significantly improved the µTBS of VIT, especially after aging, but did not improve the µTBS of 3D printed resins. Sandblasting was not beneficial for 3D printed resins, although is crucial for adhesive cementation of milled temporary resins. Airborne particle abrasion affects the integrity of 3D-printed resins, without producing a benefit on the microtensile bond strength of these materials. However, sandblasting is crucial to achieve a high bond strength on milled temporary resins.

Resumen Evaluar la resistencia adhesiva en microtracción (µTBS) de dos cementos resinosos a resinas CAD/CAM impresas y fresadas indicadas para restauraciones provisionales. Bloques (5 x 5 x 5mm) de tres resinas impresas (Cosmos3DTemp / Yller; Resilab3D Temp / Wilcos and SmartPrint BioTemp, / MMTech) y una resina fresada (VitaCAD-Temp, VITA) fueron fabricados. La mitad de los especímenes fueron arenados y el resto no recibió tratamiento mecánico. Dos bloques con condiciones de tratamiento iguales fueron cementados con cemento resinoso (PanaviaV5 / Kuraray Noritake y RelyX Ultimate / 3M Oral Care). Después de 24 horas los bloques fueron seccionados en palitos de 1 mm² de área. En la mitad de los especímenes se midió la TBS inmediatamente y el resto fue termociclado (5000 ciclos, 30s remojo, 5s transferencia) antes de la prueba de TBS. Se aplica un análisis estadístico por Modelo Linear General con 4 factores (material*arenado*cemento*termociclado). La resina VITA presentó la menor µTBS, independientemente del cemento usado, el arenado y el termociclado. Sin embargo, el arenado aumentó la µTBS de VIT, especialmente después del termociclado. Por otro lado, el arenado no resultó en un aumento significativo de la µTBS de las resinas impresas. El arenado no fue beneficiosos para las resinas impresas, aunque es un paso crucial para la cementación adhesive de las resinas fresadas. El arenado afecta la integridad de las capas de las resinas impresas, sin generar un beneficio en la TBS.

SEMICONDUCTOR INDUSTRY IN INDIA- USHERING ITS WAY INTO A NEW ERA

This paper focuses on the current state of the semiconductor industry at the global level as well as in India. With semiconductor chips emerging as the new gold, its demand is highest now than it was ever before. The demand for semiconductor chips in India is said to reach a gure of whopping US 110 billion dollars by 2030. In recent years, this industry has witnessed a crunch in its supply due to supply-side and demand-side constraints. This paper sheds light on the causes of these limits. Moreover, many countries are acquainted with this industry's scope in the future. India recognizes its dependence on countries like China for semiconductors. So, it aims to become a manufacturing hub for this industry and not just remain a fabless industry. However, India is encountering hurdles in this process. With this perception, this study has tried to explore India's initiatives in this direction. Keeping in mind India's vision of Aatmanirbhar Bharat, it seems like it's a long and rough road ahead to make the semiconductor industry in India, a self-reliant industry. This analytical study infers that overcoming these obstacles is going to become increasingly onerous.

Análise microbiológica de sushi comercializado em Rio Branco, Acre / Microbiological analysis of sushi marketed in Rio Branco, Acre / Análisis microbiológico de sushi comercializado en Rio Branco, Acre

O Brasil é um dos países mais diversificados no ramo gastronômico oferecendo vários alimentos diferentes aos seus consumidores, com base nos próprios pratos típicos ou provenientes de outras culturas. O pescado trata-se de um alimento perecível que necessita de atenções especiais em seu processamento. Falhas nas condições higiênico-sanitárias, associadas com a não cocção do alimento, podem ocasionar em uma contaminação e proliferação de bactérias, o que leva à uma grande preocupação a nível de saúde pública. O estudo analisou os aspectos microbiológicos de sushi comercializado na cidade de Rio Branco ­ Acre verificando os parâmetros de qualidade e as condições higiênicas sanitárias, comparando os resultados obtidos com a legislação vigente estabelecida pela ANVISA. Foram escolhidos 5 estabelecimentos aleatoriamente, sendo escolhidas 3 amostras de sushis do tipo niguiri de cada. As análises microbiológicas incluíram coliformes totais e coliformes termotolerantes utilizando a técnica dos tubos multiplos e a técnica de semeadura por profundidade para mesófilos e Salmonella. Constatou-se que todas as amostras tiveram um crescimento bacteriano e presença sugestiva de Salmonella, tornando o alimento impróprio para o consumo e mostrando uma falha nas condições higiênico- sanitária ao qual o sushi é processado e armazenado. É necessário maior fiscalização dos órgãos responsáveis e cuidado dos estabelecimentos que vendem sushi na cidade de Rio Branco, para que o produto vendido seja de boa qualidade e não cause malefícios a saúde de quem o consome.(AU)

Brazil is one of the most diversified countries in the gastronomic field, offering several different foods to its consumers, based on typical dishes or from other cultures. Fish is a perishable food that requires special attention in its processing. Failures in hygienic-sanitary conditions, coupled with the consumption of undercooked food, can lead to contamination and the proliferation of bacteria, which raises significant concerns regarding public health. The study analyzed the microbiological aspects of sushi sold in the city of Rio Branco - Acre, verifying the quality parameters and the hygienic sanitary conditions, comparing the obtained results with the current legislation established by ANVISA. Five establishments were randomly selected, and three samples of nigiri sushi were chosen from each establishment. The microbiological analysis included total coliforms and thermotolerant coliforms using the multiple tube technique, as well as depth seeding technique for mesophiles and Salmonella. It was found that all samples exhibited bacterial growth and suggested the presence of Salmonella, rendering the food unsuitable for consumption and indicating a failure in the hygienic-sanitary conditions under which the sushi was processed and stored. Greater inspection by the responsible authorities and improved care by establishments selling sushi in the city of Rio Branco are necessary to ensure that the product sold is of good quality and does not pose harm to the health of consumers.(AU)

Brasil es uno de los países más diversificados en el campo gastronómico, ofreciendo muchos alimentos diferentes a sus consumidores, basados en platos típicos ode otras culturas El pescado es un alimento perecedero que necesita especial atención en su elaboración. Las fallas en las condiciones, higiénico-sanitarias asociadas a la no cocción de los alimentos, pueden conducir a la contaminación y proliferación de bacterias, lo que genera una gran preocupación en términos de salud pública. El estudio analizó los aspectos microbiológicos del sushi comercializado en la ciudad de Rio Branco - Acre, verificando los parámetros de calidad y las condiciones higiénicas sanitarias, comparando los resultados obtenidos con la legislación vigente establecida por la ANVISA. Se eligieron 5 establecimientos al azar, y de cada uno se escogieron 3 muestras de sushi niguiri. Los análisis microbiológicos incluyeron coliformes totales y coliformes termotolerantes mediante la técnica de tubos múltiples y la técnica de siembra profunda para mesófilos y Salmonella. Se encontró que todas las muestras presentaban crecimiento bacteriano y la sugestiva presencia de Salmonella, lo que hace que el alimento no sea apto para el consumo y presenta una falla en las condiciones higiénico-sanitarias en las que se procesa y almacena el sushi. Se necesita mayor fiscalización por parte de los órganos responsables y cuidado de los establecimientos que venden sushi en la ciudad de Rio Branco, para que el producto vendido sea de buena calidad y no cause daño a la salud de quien lo consume.(AU)

Development of a CLDN18.2-targeting immuno-PET probe for non-invasive imaging in gastrointestinal tumors / 药物分析学报

Claudin18.2(CLDN18.2)is a tight junction protein that is overexpressed in a variety of solid tumors such as gastrointestinal cancer and oesophageal cancer.It has been identified as a promising target and a potential biomarker to diagnose tumor,evaluate efficacy,and determine patient prognosis.TST001 is a recombinant humanized CLDN18.2 antibody that selectively binds to the extracellular loop of human Claudin18.2.In this study,we constructed a solid target radionuclide zirconium-89(89Zr)labled-TST001 to detect the expression of in the human stomach cancer BGC823CLDN18.2 cell lines.The[89Zr]Zr-des-ferrioxamine(DFO)-TST001 showed high radiochemical purity(RCP,＞99％)and specific activity(24.15±1.34 GBq/μmol),and was stable in 5％human serum albumin,and phosphate buffer saline(＞85％RCP at 96 h).The EC50 values of TST001 and DFO-TST001 were as high as 0.413±0.055 and 0.361±0.058 nM(P＞0.05),respectively.The radiotracer had a significantly higher average standard uptake values in CLDN18.2-positive tumors than in CLDN18.2-negative tumors(1.11±0.02 vs.0.49±0.03,P=0.0016)2 days post injection(p.i.).BGC823CLDN18.2 mice models showed high tumor/muscle ratios 96 h p.i.with[89Zr]Zr-DFO-TST001 was much higher than those of the other imaging groups.Immunohistochemistry results showed that BGC823CLDN18.2 tumors were highly positive(+++)for CLDN18.2,while those in the BGC823 group did not express CLDN18.2(-).The results of ex vivo biodistribution studies showed that there was a higher distribution in the BGC823CLDN18.2 tumor bearing mice(2.05±0.16％ID/g)than BGC823 mice(0.69±0.02％ID/g)and blocking group(0.72±0.02％ID/g).A dosimetry estimation study showed that the effective dose of[89Zr]Zr-DFO-TST001 was 0.0705 mSv/MBq,which is within the range of acceptable doses for nuclear medicine research.Taken together,these re-sults suggest that Good Manufacturing Practices produced by this immuno-positron emission tomog-raphy probe can detect CLDN18.2-overexpressing tumors.

Application of a comprehensive risk assessment method for occupational disease hazards of employers in occupational health classification management of wooden furniture manufacturing factories / 环境与职业医学

Background The contradiction between science and operability has always existed in the model of classified occupational health supervision and management. Comprehensive risk assessment method for occupational disease hazards of employers provides risk grading and classification for occupational health management, and it's a new attempt to explore classification supervision and law enforcement. Objective To apply a comprehensive risk assessment method for occupational disease hazards of employers to estimate health risk level of wood furniture enterprises, discuss its advantages and disadvantages, and provide a basis for improving the classified management of occupational health. Methods Seven typical factories were selected in counties with highly concentrated wooden furniture manufacturing. Occupational health field investigation and testing were carried out to estimate occupational disease hazard risk level (Ⅰ, Ⅱ, and Ⅲ). A self-rated checklist was applied to score occupational health management status by interviewing employers, one by one, and to determine occupational health management status grade (A, B, and C) by the score. Thus, a comprehensive risk level (Class A, Class B, and Class C) of a specific factory was obtained from a matrix of occupational disease hazard risk level and management status grade. Risk verification was carried out based on any abnormality reported by regular occupational physical examination in past 3 years. Results Defects in occupational health management were identified in all 7 factories, among which 6 were grade C with key nonconformities (poor), and 1 was grade B (medium). Disqualified occupational disease hazards were found in 6 of 7 factories, and the workstation-specific disqualified rates were 26.09% (12/46) for noise, 14.71% (5/34) for wood dust (hard), and 12.50% (1/8) for xylene. Level Ⅱ (medium) of occupational disease hazard risk was estimated in 5 of 7 factories, while level Ⅲ (high) in 2 factories. All 7 factories were class C (high risk) accessed by the comprehensive risk assessment method for occupational disease hazards. The occupational health surveillance documents showed 636 batches of regular occupational physical examination were ordered by the 7 employers, and a total of 37 workers from 5 factories reported abnormalities in physical examination, among which 3 workers reported dust exposure and 34 workers reported noise exposure. Conclusion The comprehensive risk assessment method for occupational disease hazards of employers is not able to perform with satisfaction in occupational health classification of wooden furniture manufacturing factories yet. It is necessary to expand the pilot to improve this assessment method and develop an efficient supervision mechanism to ensure the authenticity of the data before it is popularized and applied in classified occupational health management.

Application and comparison of three occupational health risk assessment methods in automobile manufacturing enterprises / 环境与职业医学

Background The complex and diverse occupational disease hazards in automobile manufacturing industry pose high occupational health risks to workers. Objective To explore the methods that can accurately reflect the workplace health risk grade of automobile manufacturing enterprises, and to guide enterprises to practice risk classification management. Methods Comprehensive index method, International Commission on Mining and Metals occupational health risk assessment method (ICMM method), and risk index method were used toassess health risks of occupational disease hazards in major workstations such as welding, polishing, and painting in three automobile manufacturing enterprises in Hunan Province. Kappa consistency test was used to test the grading results of the three assessment methods. The re-examine results and detection rate of contraindications of occupational health examinations in the past three years were used to verify the assessment results. Results The results of comprehensive index method showed that the hazards of each selected workstation in enterprises A and B were evaluated as grade 2-3, among which NO2 in enterprise A was grade 3, and welding fume, NO2, and formaldehyde in enterprise B were all grade 3. The hazards of each selected workstation in enterprise C were grade 3-4, among which NO2 and benzene in were grade 4, and welding fume, manganese and its compounds, grinding wheel dust, and xylene were grade 3. The hazards evaluated by ICMM quantitative method were grade 2 and grade 5, among which manganese and its compounds in enterprise A and welding fume, grinding wheel dust, and benzene series in enterprise C were graded as grade 5. The hazards evaluated by risk index method were grade 1-4, among which manganese and its compounds in enterprises A and B were grade 3, and manganese and its compounds and benzene in enterprise C were grade 4. The Kappa value between comprehensive index method and ICMM method was 0.084 (P>0.05), that between comprehensive index method and risk index method was −0.046 (P>0.05), and that between ICMM method and risk index method was 0.014 (P>0.05), indicating poor consistency. By comparing the results of occupational health surveillance with the results of occupational health risk assessment, one worker was found to have occupational contraindication of manganese exposure and 1 worker was found to have excessive manganese in hair in enterprise A. However, the comprehensive index method graded low risk for manganese and its compounds in enterprise A and the result is conservative. The key workstations identified by ICMM method were consistent with the occupational health examination results, but the assessment grades were all extremely high risk, and the results were too strict. One worker was found to be contraindicated to welding fumes, and 2 polishers were found to have severe mixed pulmonary ventilation dysfunction in enterprise C. Mild and moderate pulmonary ventilation dysfunction was found to be common in welding and polishing workstations in each enterprise. The assessment results of welding fumes and grinding wheel dust by the risk index method were negligible risks, which were inconsistent with the occupational health examination results. Conclusion The comprehensive index method, ICMM method, and risk index method can basically identify workstations with serious occupational hazards, but they have certain limitations and applicability. In general, the evaluation results of the comprehensive index method were generates more consistent with the results with occupational health surveillance than the other two methods, is more comprehensive and objective in consideration, and is more suitable for health risk assessment of automobile manufacturing enterprises.

Job burnout and influencing factors among Chinese manufacturing employees / 环境与职业医学

Background Manufacturing industry is the main body of China's national economy, and manufacturing employees provide solid guarantee and support for the vigorous development of China's manufacturing industry. The research on job burnout of manufacturing employees is helpful to prevent or alleviate the health damage and economic loss caused by job burnout. Objective To investigate the status and influencing factors of job burnout among manufacturing employees in China, and evaluate the potential mediating effect of job burnout between job stress and depressive symptoms. Methods A cross-sectional study was performed from August to October 2019 and from June to September 2020 in seven provinces of China. Study participants were recruited from 21 manufacturing companies covering 11 manufacturing subdivisions using multistage stratified cluster sampling. General Burnout Scale, Core Occupational Stress Scale, and Patient Health Questionnaire-9 were used to evaluate job burnout, job stress, and depressive symptoms. Mann-Whitney U test and Kruskal-Wallis H test were used to compare data between two independent samples and multiple independent samples of measurement data; Pearson χ2 test was used to compare the rate of enumeration data; Spearman rank correlation analysis was used to evaluate correlation between selected variables; binary logistic regression was used for multivariate analysis; stepwise regression and bias-corrected Bootstrap method were used to test potential mediating effect. Results A total of 10973 valid questionnaires were collected. The M (P25, P75) scores of exhaustions, cynicism, professional efficacy, job burnout, job stress, and depressive symptoms were 1.6 (0.4, 3.0), 1.0 (0.2, 2.2), 4.8 (3.2, 5.7), 1.6 (0.8, 2.5), 45.0 (40.0, 50.0), and 7.0 (4.0, 11.0), respectively. The positive rates of job burnout, job stress, and depressive symptoms were 53.4% (5865/10973), 28.4% (3116/10973), and 29.4% (3231/10973), respectively. The influencing factors of job burnout were gender (versus male; OR for female=0.852), age (versus≤25 years old; ORs for 26-30, 31-40, 41-50, 51-60 years old=0.824, 0.819, 0.738, 0.677), education level (versus junior high school or below; ORs for senior high school/technical secondary school, junior college/vocational college, graduate school or above=1.119, 1.345, 1.331), income per month (versus＜3000 yuan; ORs for 3000-4999, 5000-6999, 7000-8999, 9000-10999, ≥11000 yuan=0.513, 0.470, 0.430, 0.375, 0.411), position (versus assembly line; OR for non-assembly line=0.814), average weekly working hours (versus ≤40 h; ORs for 61-70, ＞70 h=1.199, 1.519), and drinking (versus non-drinking; OR for drinking=1.261). Job burnout was positively correlated with job stress and depressive symptoms (r=0.556, 0.508, P<0.001). Job burnout played a partial mediating role between job stress and depressive symptoms, and its contribution value accounted for 63.2% of the total effect. Conclusion Manufacturing industry employees' job burnout problem is prominent in China, and there are many factors affecting job burnout. Job burnout may play a partial mediating role between job stress and depressive symptoms in the target group.

Influencing factors and population attributable risk percent of low back pain in automobile assemblers / 中国职业医学

Objective: To investigate the influencing factors and population attributable risk percent (PAR%) of low back pain in automobile assemblers. Methods: A total of 634 assemblers from 11 automobile manufacturers in Shiyan City, Hubei Province were chosen as research subjects using judgment sampling method. The prevalence of low back pain in the past one year was investigated using Musculoskeletal Disorders Questionnaire. PAR% was used to analyze the contribution of influencing factors to low back pain. Results: The annual prevalence of low back pain was 68.8%. The results of multivariate logistics regression showed that length of service>15 years, high school or secondary college education or above, standing most of the time, sitting most of the time, the proportion of cumulative time of poor posture in work shift time ≥1/8, and bending for insufficient height of working space were the risk factors for low back pain (all P<0.05). The PAR% of the proportion of cumulative time of poor posture in work shift time ≥1/8 was 43.0%, 37.8% for standing most of the time, and 12.8% for bending for insufficient height of working space. Conclusion: The annual prevalence of low back pain was higher in automobile assemblers. The influencing factors included individual factors and occupational factors. The proportion of cumulative time of poor posture in work shift time ≥1/8, standing most of the time and bending for insufficient height of working space should be taken as the priority intervention factors to reduce the prevalence of low back pain among assemblers in this enterprise.

Analysis of the status of occupational disease prevention and control of enterprises in mining and manufacturing industries in China in 2019 / 中华劳动卫生职业病杂志

Objective: To analyze the status of prevention and treatment of occupational diseases among mining and manufacturing industries in China in 2019, provide the scientific basis for the formulation and revision of policies and standards of prevention and treatment of occupational diseases. Methods: In May 2022, Collecting data of a project named Surveillance of Occupational Hazards in the Workplace in 2019 through the National Surveillance System for Occupational Hazards in the workplace. Compare the status of prevention and treatment of occupational diseases in 63 563 enterprises of mining and manufacturing industries among different dimensions. Results: The training rate of managers was 76.17% and that of occupational health managers was 76.97%. The rate of reporting of occupational diseases hazardous items was 67.58%, the rate of launching of the detection of occupational hazards was 57.16%, and the rate of launching of occupational health examination was 62.42%. Excluding the distribution rate of dust mask, the installation rate of various occupational prevention facilities and the distribution rate of gas mask and hearing protector were less than 80%. The differences in all the indicators among different areas, enterprise scales, economic types were statistically significant (P<0.05) . Conclusion: There are still some enterprises which are relatively weak in the ability of the prevention and treatment of occupational diseases in China. Measures such as special support, guidance and strengthen supervision should be taken towards those enterprises toimprove the awareness of prevention and treatment of occupational diseases and the level of that.

Data mining in traditional Chinese medicine product quality review / 中国中药杂志

The traditional Chinese medicine(TCM) enterprises have accumulated a large amount of product quality review(PQR) data. Mining these data can reveal the hidden knowledge in production and helps improve pharmaceutical manufacturing technology. However, there are few studies involving the mining of PQR data and thus enterprises lack the guidance to analyze the data. This study proposed a method to mine the PQR data, which consisted of 4 functional modules: data collection and preprocessing, risk classification of variables, risk evaluation by batches, and the regression analysis of quality. Further, we carried out a case study of the formulation process of a TCM product to illustrate the method. In the case study, the data of 398 batches of products during 2019-2021 were collected, which contained 65 process variables. The risks of variables were classified according to the process performance index. The risk of each batch was analyzed through short-term and long-term evaluation, and the critical variables with the strongest impact on the product quality were identified by partial least square regression. The results showed that 1 variable and 13 batches were of high risk, and the critical process variable was the quality of the intermediates. The proposed method enables enterprises to comprehensively mine the PQR data and helps to enhance the process understanding and improve the quality control.

Methodology and application of process analytical technology (PAT) for traditional Chinese medicine manufacturing:a review / 中国中药杂志

Owing to the advancement in pharmaceutical technology, traditional Chinese medicine industry has seen rapid development. Preferring conventional manufacturing mode, pharmaceutical enterprises of traditional Chinese medicine have no effective process detection tools and process control methods. As a result, the quality of the final products mainly depends on testing and the quality is inconsistent in the same batch. Process analytical technology(PAT) for traditional Chinese medicine manufacturing, as one of the key advanced manufacturing techniques, can break through the bottleneck in quality control of medicine manufacturing, thus improving the production efficiency and product quality and reducing the material and energy consumption. It is applicable to the process control and real-time release of advanced manufacturing modes such as intelligent manufacturing and continuous manufacturing. This paper summarized the general idea of PAT for traditional Chinese medicine manufacturing. Through the analysis of the characteristics and status quo of the technology, we summed up the methodology for the continuous application and improvement of PAT during the whole life-cycle of traditional Chinese medicine. The five key procedures(process understanding, process detection, process modeling, process control, and continuous improvement) were summarized, and the application was reviewed. Finally, we proposed suggestions for the technical and regulatory challenges in implementing PAT in traditional Chinese medicine industry. This paper aims to provide a reference for development and application of PAT in advanced manufacturing, intelligent manufacturing, and continuous manufacturing of traditional Chinese medicine industry.

Methodology for adaptive decision--making research on manufacturing process of traditional Chinese medicine based on deep reinforcement learning / 中国中药杂志

The manufacturing process of traditional Chinese medicine is subject to material fluctuation and other uncertain factors which usually cause non-optimal state and inconsistent product quality. Therefore, it is necessary to design and collect the quality-rela-ted physical parameters, process parameters, and equipment parameters in the whole manufacturing process of traditional Chinese medicine for digitization and modeling of the process. In this paper, a method for non-optimal state identification and self-recovering regulation was developed for active quality control in the manufacturing process of traditional Chinese medicine. Moreover, taking vacuum belt drying process as an example, a DQN algorithm-based intelligent decision model was established and verified and the implementation process was also discussed and studied. Thus, the process parameters-based self-optimization strategy discovery and path planning of optimal process control were rea-lized in this study. The results showed that the deep reinforcement learning-based artificial intelligence technology was helpful to improve the product quality consistency, reduce production cost, and increase benefit.

Current situation and prospect of 3D printing technology in pharmaceutical preparations / 中国药科大学学报

@#With the rapid advancement of science and technology, the application of 3D printing technology for personalized drug manufacturing is becoming increasingly sophisticated.Compared to traditional manufacturing technology, 3D printing can easily customize preparations with specific sizes, shapes and release behaviors for personalized drug use.This review summarizes the principles of several 3D printing technologies commonly used in drug manufacturing, lists the unique advantages and application examples of 3D printing technology for pharmaceutical preparation, analyses the current research status and development trends of the global industry of drug 3D printing, and summarizes the current problems and challenges facing drug 3D printing, aiming to provide some guidance for researchers of 3D printed drugs.

Prevalence and risk factors of work-related musculoskeletal disorders in upper back of welders in an automobile factory / 环境与职业医学

Background China's automobile manufacture is a labor-intensive industry, and most of the welding tasks are manual operations. It is often necessary to observe the solder joints during operation, and there are many adverse health outcome-related factors involved in the work process. However, the research on the prevalence and risk factors of work-related musculoskeletal disorders (WMSDs) in the upper back of welders is still insufficient. Objective To explore the prevalence and risk factors of WMSDs in the upper back of welders from an automobile factory. Methods This was a cross-sectional study. A cluster random sampling method was used to select 972 electric welders from an automobile factory as the study subjects. The Musculoskeletal Disorders Questionnaire was used to estimate the prevalence of WMSDs in the upper back in the past year. Results The prevalence rate of WMSDs in the upper back in the welders was 42.2% (410/972). The positive rates of studied occupational risk factors were 72.5% (705/972) for maintaining same posture for a long time, 71.8% (698/972) for bending and twisting for a long time, and 64.7% (629/972) for repetitive trunk movements. The univariate analysis showed that the prevalence rates of WMSDs were significantly different among workers categorized by gender, working age, twisting and/or bending for a long time, working in the same position for a long time, lifting heavy objects in an uncomfortable position, repetitive trunk movements, being unable to exert energy due to discomfort, work involving cold or temperature changes, personnel shortage, no rest between work, working hours per week, and working in an uncomfortable position (P<0.05). The results of multiple logistic regression indicated that female, working in the same position for a long time, working in an uncomfortable position (frequently), lifting heavy objects in an uncomfortable position, and being unable to exert energy due to discomfort were associated with higher risks of reporting WMSDs in the upper back (OR=2.37, 1.46, 1.76, 1.44, and 1.50, respectively, P<0.05); the risk of reporting WMSDs in the upper back increased by 95%, 157%, and 196% for every 10 h increase in weekly working hours (41-50 h, 51-60 h, ≥61 h vs ≤40 h); adequate rest time was associated with a lower risk for WMSDs in the upper back (OR=0.70, 95%CI: 0.49-0.98). Conclusion The prevalence rate of WMSDs in the upper back of welders in the automobile factory is high, and many occupational risk factors are involved. Measures should be taken for intervention and prevention.

Data-driven engineering framework with AI algorithm of Ginkgo Folium tablets manufacturing

Smart manufacturing still remains critical challenges for pharmaceutical manufacturing. Here, an original data-driven engineering framework was proposed to tackle the challenges. Firstly, from sporadic indicators to five kinds of systematic quality characteristics, nearly 2,000,000 real-world data points were successively characterized from Ginkgo Folium tablet manufacturing. Then, from simplex to the multivariate system, the digital process capability diagnosis strategy was proposed by multivariate Cpk integrated Bootstrap-t. The Cpk of Ginkgo Folium extracts, granules, and tablets were discovered, which was 0.59, 0.42, and 0.78, respectively, indicating a relatively weak process capability, especially in granulating. Furthermore, the quality traceability was discovered from unit to end-to-end analysis, which decreased from 2.17 to 1.73. This further proved that attention should be paid to granulating to improve the quality characteristic. In conclusion, this paper provided a data-driven engineering strategy empowering industrial innovation to face the challenge of smart pharmaceutical manufacturing.

Research status and development of biodegradable zinc alloy as orthopedics implant / 生物医学工程学杂志

Znic (Zn) alloys with good cytocompatibility and suitable degradation rate have been a kind of biodegradable metal with great potential for clinical applications. This paper summarizes the biological role of degradable Zn alloy as bone implant materials, discusses the mechanical properties of different Zn alloys and their advantages and disadvantages as bone implant materials, and analyzes the influence of different processing strategies (such as alloying and additive manufacturing) on the mechanical properties of Zn alloys. This paper provides systematic design approaches for biodegradable Zn alloys as bone implant materials in terms of the material selection, product processing, structural topology optimization, and assesses their application prospects with a view to better serve the clinic.

Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅰ): classification of processing routes / 中国中药杂志

Oral solid dosage(OSD) occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines. Processing route is the foundation for the research and development of traditional Chinese medicine OSDs. On the basis of prescriptions and preparation methods of 1 308 traditional Chinese medicine OSDs recorded in the Chinese Pharmacopoeia, we summarized the patterns of processing routes of both modern dosage forms(tablets, granules, and capsules) and traditional dosage forms(pills and powder) and constructed a manufacturing classification system(MCS) based on the processing routes. Based on the MCS, statistical analyses were conducted respectively on medicinal materials, pharmaceutical excipients, extraction solvents in the pretreatment process, crushed medicinal materials, methods of concentration and purification, and methods of drying and granulation, aiming to uncover the process features. The results showed that each dosage form can be prepared via different routes with different processing methods of decoction pieces and raw materials for dosage preparation. The raw materials for dosage form preparation of traditional Chinese medicine OSDs included total extract, semi-extract, and total crushed powder, which accounted for different proportions. The raw materials for traditional dosage forms are mainly decoction pieces powder. Semi-extracts are the main raw materials for tablets and capsules, which account for 64.8% and 56.3%, respectively. Total extracts are the main raw materials for granules, with a proportion of 77.8%. Compared with tablets and capsules, traditional Chinese medicine granules with dissolubility requirements had a larger proportion of water extraction process, a higher proportion of refining process(34.7%), and a lower proportion of crushed medicinal mate-rials in semi-extract granules. There are four ways to add volatile oil to the modern dosage forms of traditional Chinese medicine. In addition, some new technologies and processes have been used in concentration, filtration, and granulation processes of traditional Chinese medicine OSDs, and the application of pharmaceutical excipients is diversified. The results of this study are expected to provide reference for the processing route design and upgrading of OSDs for new traditional Chinese medicines.

Research progress and maturity assessment of continuous manufacturing of traditional Chinese medicine / 中国中药杂志

The pharmaceutical manufacturing model is gradually changing from intermittent manufacturing to continuous manufacturing and intelligent manufacturing. This paper briefly reviewed the supervision and research progress in continuous pharmaceutical manufacturing in China and abroad and described the definition and advantages of continuous pharmaceutical manufacturing. The continuous manufacturing of traditional Chinese medicine(TCM) at the current stage was summarized in the following three terms: the enhancement of the continuity of intermittent manufacturing operations, the integration of continuous equipment to improve physical continuity between units, and the application of advanced process control strategies to improve process continuity. To achieve continuous manufacturing of TCM, the corresponding key technologies, such as material property characterization, process modeling and simulation, process analysis technology, and system integration, were analyzed from the process and equipment, respectively. It was proposed that the continuous manufacturing equipment system should have the characteristics of high speed, high response, and high reliability, "three high(H~3)" for short. Considering the characteristics and current situation of TCM manufacturing, based on the two dimensions of product quality control and production efficiency, a maturity assessment model for continuous manufacturing of TCM, consisting of operation continuity, equipment continuity, process continuity, and quality control continuity, was proposed to provide references for the application of continuous manufacturing technology for TCM. The implementation of continuous manufacturing or the application of key continuous manufacturing technologies in TCM can help to systematically integrate advanced pharmaceutical technology elements and promote the uniformity of TCM quality and the improvement of production efficiency.