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.

Clinical study of polyetheretherketone resin-bonded bridge for restoring anterior missing teeth in patients with periodontitis / 口腔疾病防治

Objective@#To study the clinical effect of a polyetheretherketone (PEEK) bonding bridge on the loss of 3 internal incisors in patients with periodontitis.@*Methods@#This study was reviewed and approved by the ethics committee, and informed consent was obtained from the patients. Thirty-eight patients with periodontitis and 3 missing central or lateral teeth were selected to undergo restoration with a PEEK bonding bridge and then returned to the hospital 3, 6, 12, and 24 months after the restoration was completed. The survival rate of the restorations was assessed by the modified USPHS/Ryge criteria. The plaque index, gingival index, periodontal probing depth and attachment loss of the abutments were recorded, and the changes in periodontal tissues after restoration were observed and compared.@*Results@#Over 24 months of clinical follow-up observation of 38 patients, only 1 patient underwent secondary bonding after partial debonding (evaluated as grade B), while bonding was successful in the other 37 cases (evaluated as grade A). The plaque index, gingival index and periodontal probing depth were significantly lower after restoration than before (P<0.05). There was no significant change in attachment loss between before and after restoration (P>0.05).@*Conclusion@#For periodontitis patients missing 3 internal incisors, short-term PEEK bonding bridge repair has good clinical efficacy.

Digital repair for a patient with limited mouth opening: a case report and literature review / 口腔疾病防治

Objective@#To explore an accurate method to obtain an intraoral model of patients with specific limited mouth opening (microstomia) due to systemic scleroderma.@*Methods@#This study followed medical ethics, and informed consent has been obtained from patients. A case of Ken's Type I mandibular dentition defect scleroderma with limited mouth opening was addressed with digital technology as the leading method combined with the traditional impression method of segmental impression. Individual trays were made based on the patient's left and right mandibular dentition, and segmented molds were obtained. Simultaneously, intraoral scanning was performed to obtain the morphological data of both the soft and hard tissues of the upper and lower mandibles. After each part of the model was obtained, the mandibular model was scanned and digitally aligned to form the final denture model, and the final removable partial denture was designed and made by computer aided design/computer aided manufacturing (CAD/CAM) technology. At the same time, combined with the literature, the diagnosis and treatment of removable partial denture in patients with limited mouth opening were retrospectively analyzed.@*Results@#The denture was well retained and achieved a good repair effect. The patients expressed satisfaction with the mastication efficiency and other functions of the denture. The findings of the literature review show that the integration of digital technology with the traditional impression method, along with computer fitting, can accurately obtain the patient's oral model and facilitate successful follow-up repairs. However, when the anterior mandibular dentition of the patient is absent, the margin of error is increased in this procedure, which deserves further exploration.@*Conclusion@#Utilizing digital technology as the leading method, combined with the traditional impression method of segmental impression, for the repair of dental defects in patients with limited mouth opening, has proven to be effective. Thus, patients report a positive medical experience with high satisfaction, indicating that this approach is worthy of clinical promotion.

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.

Utility of 3d printing in orthopaedic: a systematic review

The use of 3-Dimensional (3D) printing in orthopaedics keeps pace with technical advancements. However, due to its novelty, few research have examined its application. Therefore, our study aimed to assess the utility of 3D printing in orthopaedics use. We conducted a systematic review study during the period of April-May. Article search was conducted in Google Scholar, National Center for Biotechnology Information, Clinical Key, Pubmed, and Science Direct. We included five publications with a total of 99 patients. Our findings indicate that the orthopaedic application and utilization of 3D printing technologies are expanding. Despite the relative paucity of evidence, these findings suggest the utility of 3D printing technology in a variety of intraoperative deformity correction applications.

El uso de la impresión tridimensional (3D) en ortopedia sigue el ritmo de los avances técnicos. Sin embargo, debido a su novedad, pocas investigaciones han examinado su aplicación. Por lo tanto, el estudio tuvo como objetivo evaluar la utilidad de la impresión 3D en el uso ortopédico. Se realizó un estudio de revisión sistemática durante el período de abril a mayo. La búsqueda de artículos se realizó en Google Scholar, National Center for Biotechnology Information, Clinical Key, Pubmed y Science Direct. Se incluyeron cinco publicaciones con un total de 99 pacientes. Nuestros hallazgos indican que actualmente se expanden la aplicación ortopédica y la utilización de las tecnologías de impresión 3D. A pesar de la relativa escasez de evidencia, estos hallazgos sugieren la utilidad de la tecnología de impresión 3D en una variedad de aplicaciones de corrección de las deformidades intraoperatorias.

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)

Difusão de política na prática: o caso da regulação brasileira de medicamentos / Difusión de políticas en la práctica: el caso de la regulación brasileña de medicamentos / Policy diffusion in practice: the case of Brazilian medicinal products regulation

Resumo O presente estudo busca contribuir para a melhor compreensão de processos de difusão de política com base em arenas transnacionais - mais especificamente, do processo de difusão que influenciou a regulação das Boas Práticas de Fabricação (BPF) de medicamentos no Brasil num contexto envolto por atores internacionais. Por meio de pesquisa qualitativa, analisamos o processo de adesão da Agência Nacional de Vigilância Sanitária (Anvisa) ao arranjo de cooperação Pharmaceutical Inspection Co-operation Scheme (PIC/S), iniciado em 2010 e alcançado em 2021. Foi identificado um processo influenciado por 2 constelações de difusão, motivado por interesses da agência nacional em manter sua relevância e por atores que integram o Sistema Nacional de Vigilância Sanitária, no qual o modelo de equivalência e convergência regulatória do PIC/S se mostrou fundamental para a adaptação da referência internacional em nível nacional, mantendo o sistema em funcionamento. Tal processo de difusão de política ficou mais relevante nos últimos anos por ampliar a convergência regulatória e, potencialmente, tornar mais eficiente a avaliação das BPF de medicamentos pelas diversas autoridades sanitárias.

Resumen El presente estudio pretende contribuir a una mejor comprensión de los procesos de difusión de políticas, más concretamente, del proceso de difusión que influyó en la regulación de las Buenas Prácticas de Fabricación (BPF) de medicamentos en Brasil, a partir de arenas transnacionales. A través de una investigación cualitativa, analizamos el proceso de adhesión de la Agencia Nacional de Vigilancia Sanitaria (Anvisa) al Esquema de Cooperación de Inspección Farmacéutica (PIC/S), iniciado en 2010 y alcanzado en 2021. Se identificó un proceso influenciado por dos constelaciones de difusión, motivado por el interés de la agencia nacional en mantener su relevancia y por los actores que componen el Sistema Nacional de Vigilancia Sanitaria, en el que el modelo de equivalencia y convergencia normativa del PIC/S resultó fundamental para la adaptación de la referencia internacional al ámbito nacional, manteniendo el sistema nacional en funcionamiento. Este proceso de difusión de políticas adquirió aún más relevancia en años recientes al ampliar la convergencia normativa y hacer potencialmente más eficiente la evaluación de las BPF de los medicamentos por parte de las distintas autoridades sanitarias.

Abstract The present study seeks to contribute to a better understanding of policy diffusion processes, more specifically, of the diffusion process from a transnational arena that influenced the regulation of Good Manufacturing Practices (GMP) for medicinal products in Brazil in a context surrounded by international authorities. By conducting qualitative research, we analyzed the process of adhesion of the Brazilian Health Regulatory Agency (Anvisa) to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), initiated in 2010 and achieved in 2021. A process influenced by two constellations of diffusion was identified, motivated by the national agency's interests in maintaining its relevance and by actors that make up the National Sanitary Surveillance System, in which the PIC/S model of regulatory equivalence and convergence proved to be fundamental for the adaptation of the international reference to the national level, keeping the national system functioning. Such a policy diffusion process became even more relevant in the past years due to the expansion of regulatory convergence and potentially making the various health authorities' GMP assessment of medicinal products more efficient.

Analysis of Lean Six Sigma Use in Pharmaceutical Production

Abstract Over the last years, pharmaceutical industries have adopted continuous improvement and operational excellence programs to optimize processes, improve quality and reduce operational costs. Worldwide, Lean Manufacturing (LM) and Six Sigma (SS), as well as the integration of the two methods: Lean Six Sigma (LSS) are the most used approaches in the continuous improvement of industries and services. This work aims to investigate the employment of the Lean Six Sigma methodology in the productive areas of pharmaceutical companies located in Brazil. Interviews were conducted with managers of pharmaceutical industries that apply the approach. The results indicated the greater use of Lean Manufacturing tools compared to Six Sigma and the influence of specific peculiarities of the pharmaceutical industry on the benefits that are achieved with the use of Lean Six Sigma. The approach is considered of great value as it provides substantial benefits to the pharmaceutical industry. It is concluded that the work corroborates to the theoretical and empirical knowledge about the methodology use in the context of Brazilian pharmaceutical industries, as well as contributes to the implementation, reformulation, and improvement of Lean Six Sigma programs in this industrial segment.

Research progress on influencing factors of occupational injury in manufacturing workers / 环境与职业医学

Globally, manufacturing workers are one of the most vulnerable groups to occupational injuries. Occupational injuries can lead to absenteeism, disability or even death, and most of the inflicted workers involve young adults aged 18-40 years, suggesting a safety and health problem that needs close attention. In the working environment of manufacturing industry, there are a variety of occupational injury risk factors, involving individuals, equipment, environment, and management, which should be considered comprehensively. This study found comprehensive research coverage on the influencing factors of occupational injuries in manufacturing industry at individual, environmental, and management levels at home and abroad, and rich research results on the impacts of psychological factors on occupational injuries. However, factors associated with occupational injuries in equipment safety and engineering like man-machine environment need further research. Influencing factors at all levels should be comprehensively considered in the surveillance and intervention of occupational injuries in manufacturing industry to protect health and safety of workers.

Influencing factors of fall injury risks in manufacturing enterprises based on Bayesian networks / 环境与职业医学

Background Falls are one of the most important types of occupational injuries. The incidence of falls is high in manufacturing workers. However, most of the studies on falls in China focus on primary and secondary school students and the elderly, and there are few studies on falls in the occupational population. Objective To evaluate efficiency of Bayesian network model in predicting fall injury risks in manufacturing enterprise staff, and impacts from work content, work environment, enterprise status, and health management on falls and their mutual relationships, and provide a scientific basis for enterprises to carry out fall-associated injury intervention. Methods Data from the European Survey of Enterprises on New and Emerging Risks (ESENER) were used. The survey provided data on work content, working environment, enterprise status, and health management of enterprises in European countries. The outcome indicator, was fall injury risks reported in enterprises. A total of 23 potential impact factors covering work content, working environment, enterprise status, and health management were screened by least absolute shrinkage and selection operator (LASSO) regression, followed by Bayesian network model for structure learning and parameter learning and area under the curve (AUC) for model fitness evaluation, using R and Netica 5.18. Diagnostic inference analysis was also conducted to identify key influencing factors and key influencing chains of fall injury risks based on the change rate of fall injury risks. Results In 5997 enterprises surveyed, 2573 (42.9%) enterprises reported fall injury risks. Ordered by their coefficient estimates from high to low, the 14 variables (mean-squared error=0.20) selected by LASSO regression were: manual handling, repetitive arm movement, poor posture, using desktop computers, and using robots in the category of work content; abnormal temperature and noise in the category of working environment; company size and employee quality in the category of enterprise status; mental health training, regular risk assessment, availability of psychologists, health and safety procedures, and provision of psychological counseling in the category of health management. The fitting result of Bayesian network model for fall injury risks was good (AUC=0.779). The Bayesian network diagnostic inference identified five key influencing factors, including abnormal temperature (change rate=35.9%), poor posture (change rate=27.3%), noise (change rate=23.4%), manual handling (change rate=18.2%), and repetitive arm movement (change rate=5.1%). The key influencing chain was "manual handling - poor posture - repetitive arm movement - fall injury risks" (combined change rate=16.9%). Conclusion The Bayesian network model has a good predictive performance in predicting the risk of falls in manufacturing enterprises. Manufacturing enterprises need to focus on jobs involving manual handling and repetitive arm movement, identify and improve workers' poor posture and mental health problems, and avoid workers working in harsh temperature or noise environment.

Impacts of poor working conditions, occupational psychology, and enterprise risk factors on occupational injury by path analysis / 环境与职业医学

Background Occupational injuries, which can result in absenteeism, disability, or death, are closely related to poor working conditions. However, the improvement of operating conditions are often time-consuming and require significant economic inputs. Both occupational psychology and enterprise risk factors have been proved to be related to the occurrence of occupational injuries, but their roles in the influence path of adverse working conditions leading to occupational injuries remain unclear. Objective To explore the roles of occupational psychology and enterprise risk factors in the impact of adverse working conditions on occupational injury, so as to provide a scientific basis for enterprises with adverse working conditions to carry out targeted occupational injury intervention programs. Methods The survey data of 5997 manufacturing enterprises were obtained from the European Survey of Enterprises on New and Emerging Risks (ESENER) database. The data on enterprise risk characteristics, occupational injuries, working conditions, and occupational psychological factors were extracted and assigned. Occupational injury differences by enterprise categories were examined by chi-square test. Correlations between interest variables were evaluated by Spearman test. Path analysis with Bootstrap method was conducted using AMOS 26 software, and ratio of chi-square statistic to degree of freedom (χ2/ν), comparative fit index (CFI), Tucker-Lewis index (TLI), and root mean square error of approximation (RMSEA) were used to evaluate the path model candidates. The effect size and its proportion were calculated for variables (occupational psychological factors, enterprise risk factors, and adverse working conditions) included in the final model. Results The M (P25, P75) scores of occupational injuries, adverse working conditions, and occupational psychological factors were 40 (20, 50), 50 (30, 60), and 20 (10, 30), respectively. The enterprises that reported occupational injuries accounted for 25.5% (1550 enterprises) of the total enterprises. Proportions of the enterprises that reported occupational injuries varied significantly by company scale, branch companies, temporary employment, language barriers, and establishment time (P<0.05). The results of Spearman test showed that occupational injuries were positively correlated with working conditions (rs=0.440), occupational psychological factors (rs=0.205), company scale (rs=0.307), temporary employment (rs=0.282), and language barriers (rs=0.158); but negatively correlated with branch companies (rs=−0.180) and establishment time (rs=−0.176) (P<0.05). In the path analysis, the fitness indexes of the final model were χ2/ν=2.85, CFI=0.997, TLI=0.993, and RMSEA=0.018 (90%CI: 0.011, 0.025). The indirect effect size values and constituent ratios of enterprise risk factors and occupational psychological factors in the effect of adverse working conditions on occupational injuries were 0.166 (30.01%) and 0.013 (3.13%) respectively. The indirect effect size value of occupational psychological factors in the effect of enterprise risk factors on occupational injuries and its constituent ratio were 0.022 and 6.85%. Conclusion Enterprises with adverse working conditions may control the risk of occupational injuries by offering better solutions to surmount language barriers and temporary employment, developing occupational psychological intervention and optimization programs such as improving working hours system. At the same time, large enterprises, enterprises without branches, or enterprises with a long history are the focus of occupational injury prevention and control.

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.

Four critical engineering and technical problems in manufacturing measurement of traditional Chinese medicine / 中国中药杂志

Focusing on the development and quality improvement strategy of the traditional Chinese medicine(TCM) industry, the scientific and technological innovation of the new engineering of TCM should be paid attention to solve the "stuck neck" dilemma. Under the background of the ecological and industrial revolution of the scientific and technological innovation system, the super-scale information interaction and multi-dimensional integration will inevitably lead to profound changes in the manufacturing mode of TCM. Manufacturing measurement of TCM is formed on the basis of the reliability engineering theory of process control of TCM production. It is the development extension of system theory and system science ideas and a cross-fertilization discipline that combines theory with practice and adheres to the "four-oriented" re-epistemology improvement of the TCM discipline. In response to the problems of complex raw material sources, coarse process technology, unclear material basis, and poor applicability of equipment and technology in the manufacture of TCM, the transformation research mode of "aiming at the integration of pharmaceutical industry-developing intelligent production line-enabling industrial transformation" has been developed. This paper proposed the four key engineering technical problems, i.e., the identification of critical quality attributes(CQA) in the manufacture of TCM, the quality by design(QbD) and product development of the manufacturing process of TCM, the quality transfer principle and multivariate process capability index of TCM manufacturing, and the development of measurement technology and equipment of the manufacturing measurement of TCM, to achieve the systematization of quality control indicators, real-time process control, digitalization of manufacturing process, transparency of quality transfer, and intelligent whole-process control. In this paper, the new concepts, new theories, and new technologies provide a reference for the industrialization of TCM.

Preface for special issue on chemical bioproduction / 生物工程学报

Engineering efficient enzymes or microbial cell factories should help to establish green bio-manufacturing process for chemical overproduction. The rapid advances and development in synthetic biology, systems biology and enzymatic engineering accerleate the establishing feasbile bioprocess for chemical biosynthesis, including expanding the chemical kingdom and improving the productivity. To consolidate the latest advances in chemical biosynthesis and promote green bio-manufaturing, we organized a special issue on chemical bioproduction that including review or original research papers about enzymatic biosynthesis, cell factory, one-carbon based biorefinery and feasible strategies. These papers comprehensively discussed the latest advaces, the challenges as well as the possible solutions in chemical biomanufacturing.

Testing Occupational Hazard Self-Evaluation Module (OHSEM) Intervention among Workers of SME (Manufacturing) in Northern Malaysia

@#Introduction: Workplace accidents have been a persistent problem in Malaysia’s manufacturing industry, particularly for small and medium-sized enterprises (SMEs). Employee behavior has been identified as a significant contributing factor to these accidents, and research has suggested that improving safety knowledge and attitudes can enhance safety behavior. Despite this, there have been no empirical intervention studies in Malaysia to investigate the effectiveness of safety intervention programs aimed at improving SME worker safety behavior. Therefore, this study aimed to assess the efficacy of the Occupational Hazard Self-Evaluation Module (OHSEM) intervention in enhancing safety knowledge, attitudes, and behavior (KAB) among SME workers in the manufacturing sector. Methods: A quasi-experimental design with control group was utilized to evaluate the effectiveness of the OHSEM intervention. The intervention was implemented over a 12-week period on production workers in the experimental group, while the control group received no intervention. A self-administered questionnaire was distributed to 88 production workers in both groups before and after the intervention to measure the improvement of safety KAB. Descriptive analysis and an independent t-test were used to analyse the data. Results: The post-test results showed that safety KAB for the control group was moderate (mean = 2.11), while the mean score in the experimental group was high (m=4.17). Furthermore, the t-test result revealed a significant difference in safety KAB mean scores between the experimental and control groups. Conclusion: This study provides empirical evidence on the effectiveness of the OHSEM intervention in enhancing safety KAB in SMEs in the Malaysian SME (manufacturing) sector.

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.

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.