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.

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.

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.

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)

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.

Evaluation of EDM inclusion into the conventional polishing of printed Co-Cr alloy by selective laser melting / Avaliação da inclusão de EDM no polimento convencional da liga de Co-Cr impressa por fusão seletiva a laser

Objective: The selective laser melting (SLM) technique used in manufacturing results in a rougher surface that requires more satisfying processing than conventional hand-finishing operations. The electro discharge machine (EDM) has various possibilities in the adjustment of surfaces. The present study assesses whether the participation of the EDM technique with the conventional finishing and polishing methods enables surface improvement for the Cobalt-Chromium alloy fabricated by SLM. Material and Methods: Twenty discs of cobalt chromium alloy were fabricated by SLM, divided equally into two groups: (TF) control group for finishing and polishing in the conventional method in accordance with the manufacturer's recommendations; and (EF) group for conducting polishing incorporating the EDM method. Results: The EF group recorded the lowest mean value of surface roughness and the highest mean value of micro hardness compared to the TF group. Furthermore, statistically significant differences (P < 0.05) were found for surface roughness as well as micro hardness. Conclusion: Reliance of the electric discharge machine proactively within finishing and polishing procedures promotes competence in the conventional polishing method and improves the surface properties of cobalt chromium alloy printed by SLM technology (AU)

Objetivo: A técnica de fusão a laser seletiva (SLM) usada na fabricação resulta em uma superfície mais rugosa a qual requer um processamento mais satisfatório do que o acabamento manual. A máquina de eletro descarga (EDM) possui várias possibilidades no ajuste de superfícies. O presente estudo avalia se a participação da técnica EDM associada aos métodos convencionais de acabamento e polimento possibilita a melhora da superfície da liga Cobalto-Cromo fabricada através da SLM. Material e Métodos: Vinte discos de liga de cromo-cobalto foram confeccionados por SLM, e divididos igualmente em dois grupos: (TF) grupo controle, realizado acabamento e polimento pelo método convencional de acordo com as recomendações do fabricante; e (EF) grupo do polimento associado ao método EDM. Resultados: O grupo EF registrou o menor valor médio de rugosidade superficial e o maior valor médio de microdureza em relação ao grupo TF. Além disso, diferenças estatisticamente significativas (P < 0,05) foram encontradas para rugosidade superficial, assim como para a microdureza. Conclusão: A confiança na máquina de descarga elétrica proativamente nos procedimentos de acabamento e polimento promove a competência no método de polimento convencional e melhora as propriedades de superfície da liga de cromo-cobalto impressa pela tecnologia SLM(AU)

Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Avaliação do impacto de treinamento on-line nos conhecimentos e atitudes de higiene de manipuladores de alimentos / Evaluation of the impact of online training on the knowledge and attitudes of food handlers' hygiene

Introdução: Os alimentos e bebidas podem transmitir doenças quando contaminados com micro-organismos patogênicos. Os manipuladores de alimentos devem ser conscientizados quanto às medidas de higiene e Boas Práticas. Objetivo: Analisar a eficácia de qualificação em higiene e segurança de alimentos por meio de plataforma digital. Metodologia: Foi aplicado um questionário antes e após treinamento realizado de forma online e assíncrona, por meio da utilização da plataforma Google Classroom®. Resultados: Inicialmente, o público-alvo detinha 86±1% de conhecimentos e atitudes adequados,  Após o curso, atingiu média de 98±5%. Os conhecimentos prévios sobre higiene e segurança alimentar eram satisfatórios, Porém, a abordagem digital demonstrou eficiência na educação sobre higiene pessoal, ambiental e no manejo seguro dos alimentos, incluindo preparo, descongelamento, contaminação e higienização de vegetais. Discussão: A utilização de cursos a distância, por meio de plataformas digitais, tem sido apresentada como um método eficiente para levar conhecimentos e modificar as atitudes relacionadas à segurança e higiene de alimentos para os profissionais do setor de alimentação. Conclusão: A utilização de plataforma digital para oferta de qualificação em higiene e segurança de alimentos demonstrou ser eficiente para aplicação dos conteúdos relacionados a forma correta de armazenamento, contaminação cruzada, higiene das mãos, saúde do manipulador e higiene do manipulador. (AU)

Introduction: Food and beverages can transmit diseases when contaminated with pathogenic microorganisms. Food handlers must be educated about hygiene measures and Good Practices. Objective: This study aimed to evaluate the effectiveness of an online training program on food hygiene and safety using a digital platform. Methodology: A questionnaire was applied before and after asynchronous online training through the Google Classroom® platform. Results: Initially, the target audience held 86±1% adequate knowledge and attitudes. After the course, it reached an average of 98±5%. Pre-existing knowledge about food hygiene and safety was satisfactory. However, the digital approach demonstrated efficiency in educating about personal and environmental hygiene and safe food handling, including preparation, thawing, contamination, and vegetable sanitization. Discussion: Online training courses through digital platforms have been shown to be an efficient method for delivering knowledge and modifying attitudes related to food safety and hygiene for food industry professionals. Conclusion: The study also showed that the online training program was effective in delivering content related to storage, cross-contamination, hand hygiene, health of the handler, and handler hygiene.

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 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.

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.

Survey on awareness of occupational health knowledge and concept among front-line workers in the automotive manufacturing industry / 中国职业医学

Objective To investigate the awareness of occupational health knowledge and concept of front-line workers in the automobile manufacturing industry. Methods A total of 1 188 front-line workers from 47 automobile manufacturing enterprises in Guangdong Province were selected as the research subjects using the judgment sampling method. The awareness of occupational health knowledge and concept of the workers was investigated using the Personal Questionnaire for National Survey of Occupational Health Literacy for Key Populations. Results The median (25th and 75th percentiles) awareness of occupational health knowledge and concept among the research subjects was 56.00% (44.00%, 64.00%). The awareness was higher among male workers than female workers (P<0.05). The awareness was higher among married workers than workers with other marital status (P<0.05). The awareness of workers with an education level of middle school or below was lower than those in the senior high school and junior college group and bachelor's degree or above group (all P<0.05). The awareness of workers in the group with personal monthly income <5 000 was lower than that in the other two income groups with personal monthly income ≥5 000 (all P<0.05). The awareness of workers in medium and large enterprises was higher than that of workers in small and micro enterprises (all P<0.05). The awareness of workers in foreign-funded enterprises was higher than that in private enterprises and other enterprises (all P<0.05). The awareness of workers with job tenure >5-10 and >10 years was higher than that in workers with job tenure of 1-≤5 years (P<0.05). The awareness for the 25 items of occupational health knowledge and concept among the research subjects ranged from 6.14% to 96.72%, with an average awareness of 54.46% for the 25 items. Conclusion The awareness of occupational health knowledge and concept of front-line workers in automobile manufacturing industry is not high in general, and it is influenced by gender, marriage status, education level, personal monthly income, enterprise nature and scale, and job tenure.

Status and influencing factors of occupational health literacy among workers in automobile manufacturing industry in Beijing City / 中国职业医学

Objective To analyze the current status and influencing factors of occupational health literacy(OHL) among workers in automobile manufacturing industry in Beijing City. Methods A total of 1 639 frontline workers from 15 automobile manufacturing enterprises in Beijing City were selected using stratified cluster sampling method. The National Occupational Health Literacy Monitoring for Key Groups Questionnaire was used to investigate the OHL of the workers. Results The overall awareness of OHL was 60.5% in these 1 639 automobile manufacturing workers. The awareness of OHL in the four dimensions, from high to low, were basic knowledge of occupational health protection, info of healthy working style and behaviors, legal knowledge of occupational health and basic skills of occupational health protection (82.1% vs 73.2% vs 57.5% vs 43.3%, P<0.01). The multivariate logistic regression analysis results showed that gender, marriage status, education level, personal monthly income and enterprise scale were influencing factors of OHL of automobile manufacturing workers (all P<0.05). Conclusion The OHL awareness among workers of automobile manufacturing industry in Beijing City, especially the basic skills of occupational health protection and the legal knowledge of occupational health, needs to be improved. It is essential to focus on promotion and intervention of occupational health in female workers, those with low education levels, low-income levels, and workers in small- and medium-sized enterprises.

Risk assessment of occupational noise-induced hearing loss in worker in a metal tool manufacturing enterprise / 中国职业医学

Objective To evaluate the risk of occupational noise-induced hearing loss in workers in a metal tool manufacturing enterprise, and to carry out risk classification and risk management. Methods A total of 91 male noise-exposed workers from a metal tool manufacturing enterprise in Hebei Province were selected as the research subjects using the convenience sampling method. The work site survey on occupational health and the measurement on individual noise exposure level were carried out. The ISO 1999：2013 (E) Acoustics-Estimation of Noise-Induced Hearing Loss was used to predict the risk of high frequency hearing loss (HFHL) and occupational noise-induced deafness (ONID). The risk classification and risk management were conducted using the WS/T 754-2016 Guideline for Risk Management of Occupational Noise Hazard (hereinafter referred to as WS/T 754-2016). Results The individual noise exposure intensity of workers in the six work sites of the enterprise, including blade workers, sheet punching workers, roller forging workers (hoe), hole punching workers, roller forging workers(shovels), and carpenters, exceeded the national occupational exposure limit, with the maximum volume of 91.2-104.1 dB(A). Among these workers, the positions of blade workers, sheet punching workers, and roller forging workers (hoe) were identified as critical control points for noise hazards in the enterprise. The detection rates of HFHL and ONID were 24.2% and 8.8%, respectively. The risk prediction results showed that, based on the actual noise exposure time and age of the study subjects, the risk of HFHL and ONID ranged from 1.7%-48.8% and 0.0%-29.5%, respectively. The risks of HFHL caused solely by occupational noise exposure when working up to 50.0, 55.0, and 60.0 years of age were 11.4% to 64.7%, 16.4% to 65.1%, and 17.2% to 59.4%, respectively. The risks of ONID caused solely by occupational noise exposure were 0.0% to 45.5%, 4.2% to 51.7%, and 5.9% to 57.4%, respectively. Except for the blade workers, the predicted median of potential noise-induced permanent threshold shifts (NIPTS) in the other five positions were lower than the actual values of NIPTS, with the difference ranging from 3.0-28.3 dB, and 73.3% of them underestimated by 10.0 dB or more. Conclusion The outcome of noise exposure on the hearing of workers in this enterprise are severe. Risk management should be conducted according to the WS/T 755-2016.

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.