• Title/Summary/Keyword: Safety-critical

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Avantor® ACE® Wide Pore HPLC Columns for the Separation and Purification of Proteins in Biopharmaceuticals (바이오의약품의 단백질 분리 및 정제를 위한 Avantor® ACE® 와이드 포어 HPLC 컬럼 가이드)

  • Matt James;Mark Fever;Tony Edge
    • FOCUS: LIFE SCIENCE
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    • no.1
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    • pp.3.1-3.7
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    • 2024
  • The article discusses the critical role of chromatography in the analysis and purification of proteins in biopharmaceuticals, emphasizing the importance of comprehensive characterization for ensuring their safety and efficacy. It highlights the use of Avantor® ACE® HPLC columns for the separation and purification of proteins, focusing on the analysis of intact proteins using reversed-phase liquid chromatography (RPLC) with fully porous particles. This article also details the application of different mobile phase additives, such as TFA and formic acid, and emphasizes the advantages of using type B ultra-pure silica-based columns for efficiency and peak shape in biomolecule analysis. Additionally, it addresses the challenges of analyzing intact proteins due to slow molecular diffusion and introduces the concept of solid-core (or superficially porous) particles, emphasizing their benefits over traditional porous particles for the analysis of therapeutic proteins. Furthermore, it discusses the development of Avantor® ACE® UltraCore BIO columns, specifically designed for the high-efficiency separation of large biomolecules, such as proteins, and demonstrates their effectiveness in achieving high-resolution separations, even for higher molecular weight proteins like monoclonal antibodies (mAbs). In addition, it underscores the complexity of analyzing and characterizing intact protein biopharmaceuticals, requiring a range of analytical techniques and the use of wide-pore stationary phases, operated at elevated temperatures and with relatively shallow gradients. It highlights the comprehensive range of options offered by Avantor® ACE® wide pore columns, including both fully porous and solid-core particles, bonded with a variety of complementary stationary phase chemistries to optimize selectivity during method development. The use of ultrapure and highly inert base silica is emphasized for enabling the use of lower concentrations of mobile phase modifiers without compromising analyte peak shape, particularly beneficial for LC-MS applications. Then the article concludes by emphasizing the significance of reversed-phase liquid chromatography and its compatibility with mass spectrometry as a valuable tool for the separation and analysis of intact proteins and their closely related variants in biopharmaceuticals.

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Effect of the support pressure modes on face stability during shield tunneling

  • Dalong Jin;Yinzun Yang;Rui Zhang;Dajun Yuan;Kang Zhang
    • Geomechanics and Engineering
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    • v.36 no.5
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    • pp.417-426
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    • 2024
  • Shield tunneling method is widely used to build tunnels in complex geological environment. Stability control of tunnel face is the key to the safety of projects. To improve the excavation efficiency or perform equipment maintenance, the excavation chamber sometimes is not fully filled with support medium, which can reduce the load and increase tunneling speed while easily lead to ground collapse. Due to the high risk of the face failure under non-fully support mode, the tunnel face stability should be carefully evaluated. Whether compressive air is required for compensation and how much air pressure should be provided need to be determined accurately. Based on the upper bound theorem of limit analysis, a non-fully support rotational failure model is developed in this study. The failure mechanism of the model is verified by numerical simulation. It shows that increasing the density of supporting medium could significantly improve the stability of tunnel face while the increase of tunnel diameter would be unfavorable for the face stability. The critical support ratio is used to evaluate the face failure under the nonfully support mode, which could be an important index to determine whether the specific unsupported height could be allowed during shield tunneling. To avoid of face failure under the non-fully support mode, several charts are provided for the assessment of compressed air pressure, which could help engineers to determine the required air pressure for face stability.

Gender and healthcare issues related to the Protected Birth Act in Korea (보호출산제 시행과 젠더 및 보건의료 이슈)

  • Jiah Jeong
    • Women's Health Nursing
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    • v.30 no.2
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    • pp.101-106
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    • 2024
  • This paper discusses the implications of the birth notification system and the Protected Birth Act in Korea. Aiming to prevent infanticide and abandonment of infants, the law will enter into force on July 19, 2024 in South Korea. The birth notification system mandates that both parents and the head of the medical institution where the birth occurred must report the event. In parallel, the Protected Birth Act will be implemented, allowing pregnant women in crisis who wish to remain anonymous, the option to give birth outside of a hospital setting in a way that safeguards the life and health of the child. However, many issues are being raised in Korean society in advance of the implementation of the Protected Birth Act. There is widespread concern that the Protected Birth Act fails to protect either women or children, especially as it raises issues regarding the need for legislation to protect children with disabilities and to address gaps for migrant women and children. This paper examines the gender and healthcare issues relating to the Protected Birth Act, focusing on women's health and human rights. The Act continues to perpetuate discrimination against out-of-wedlock pregnancies and upholds the ideology of the traditional family model. Furthermore, the legislative process did not address protective measures for the various reasons behind child abandonment. Critical issues such as women's autonomy, safe pregnancy termination, and paternal responsibility in childbirth are also notably absent. However, with the Act set to take effect soon, it is crucial for healthcare providers to comprehend the rationale and procedures associated with birth notification and the Protected Birth Act, and to prepare for its nationwide implementation. The law defines the socially vulnerable as its main beneficiaries, and it is necessary to strengthen social safety nets to improve their access to healthcare, eliminate prejudice and discrimination against out-of-wedlock pregnancies, and embrace the diversity of our society. We eagerly anticipate future discussions on gender and healthcare issues, as well as amendments to the law that reflect real-world circumstances to provide genuine protection for pregnant women in crisis and their infants.

Benefits and Risks of Preprepared Parenteral Nutrition for Early Amino Acid Administration in Premature Infants with Very Low Birth Weight

  • Pin-Chun Chen;Hsin-Chung Huang;Mei-Jy Jeng;Feng-Shiang Cheng
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.4
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    • pp.246-257
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    • 2024
  • Purpose: Administering early parenteral amino acids to very low birth weight (VLBW) premature infants (birth body weight [BBW]<1,500 g) is challenging due to factors such as holidays, cost, and access to sterile compounding facilities. Using advance-prepared parenteral nutrition (PN) may address this issue and should be evaluated for its safety and potential benefits. Methods: We extracted data from medical records collected between July 2015 and August 2019. VLBW infants received PN for at least seven days and were split into two groups: the traditional group (n=30), which initially received a glucose solution and then PN on workdays, and the pre-preparation group (n=16), which received advance-prepared PN immediately upon admission to the neonatal intensive care unit. Results: The median BBWs of the traditional and pre-preparation groups were 1,180.0 vs. 1,210.0 g. In the initial two days, the pre-preparation group had a significantly higher amino acid intake (2.23 and 2.24 g/kg/d) than the traditional group (0 and 1.78 g/kg/d). The pre-preparation group exhibited greater head circumference growth ratio relative to birth (7th day: 1.21% vs. -3.57%, p=0.014; 21st day: 7.71% vs. 3.31%, p=0.017). No significant differences in metabolic tolerance were observed. Conclusion: Advanced preparation of PN can be safely implemented in VLBW preterm infants, offering advantages such as early, higher amino acid intake and improved head circumference growth within the first 21 days post-birth. This strategy may serve as a viable alternative in settings where immediate provision of sterile compounding facilities is challenging.

A Study on Temperature Properties Analysis for Tension Measurement of Steel Cables Using Magnetic Sensor (자기센서에 의한 강재 케이블 장력측정에서 온도특성에 대한 연구)

  • Park, Hae-won;Ahn, Bong-young;Lee, Seung-seok;Park, Jeong-hak
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.13 no.2 s.54
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    • pp.181-188
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    • 2009
  • Measuring the tensile strength of steel cables used to support bridges is a critical inspection item in terms of the safety of a bridge. Today, cable tension is measured with the vibration method and loadcell. Recently, some advanced countries have conducted studies on measuring tension with magnetic method and are suggesting prospective results. Since there were no such studies ongoing in Korea, we began a study on measuring tension with magnetic method as we are undergoing researches to improve the precision of measurements. It is necessary to consider the influence for the magnetic field and the temperature of steel cables in tension measurement of magnetic method. In this paper, we tested an output characteristic of tension sensor according to temperature and deduced temperature compensation coefficient in the given magnetic field and applied the compensation coefficient to the tension measurement system in the lab. We analyzed and evaluated testing results for the output voltages of the tension sensor according to cable tensions.

Research on Identifying Manipulated Operation Data of Cyber-Physical System Based on Permutation Entropy (순열 엔트로피 기반 사이버 물리 시스템의 조작된 운영 데이터 식별 방안 연구)

  • Ka-Kyung Kim;Ieck-Chae Euom
    • Convergence Security Journal
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    • v.24 no.3
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    • pp.67-79
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    • 2024
  • Attackers targeting critical infrastructure, such as energy plants, conduct intelligent and sophisticated attacks that conceal their traces until their objectives are achieved. Manipulating measurement data of cyber-physical systems, which are connected to the physical environment, directly impacts human safety. Given the unique characteristics of cyber-physical systems, a differentiated approach is necessary, distinct from traditional IT environment anomaly detection and identification methods. This study proposes a methodology that integrates both recursive filtering and an entropy-based approach to identify maliciously manipulated measurement data, considering the characteristics of cyber-physical systems. By applying the proposed approach to synthesized data based on a publicly available industrial control system security dataset in our research environment, the results demonstrate its effectiveness in identifying manipulated operational data.

The investigation of the applicability of Monte Carlo Simulation in analyzing TBM project requirements

  • Ulku Kalayci Sahinoglu
    • Geomechanics and Engineering
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    • v.39 no.1
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    • pp.1-11
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    • 2024
  • Geotechnical parameter estimation is critical to the design, performance, safety, and cost and schedule management in Tunnel Boring Machine projects. Since these parameters vary within a certain range, relying on mean values for evaluation introduces significant risks to the project. Due to the non-homogeneous characteristics of geological formation, data may not exhibit a normal distribution and the presence of outliers might be deceptive. Therefore, the use of reliable analyses and simulation models is inevitable in the course of the data evaluation process. Advanced modeling techniques enable comprehensive analysis of the project data and allowing to model the uncertainty in geotechnical parameters. This study involves using Monte Carlo Simulation method to predict probabilistic distributions of field data, and therefore, establish a basis for designs and in turn to minimize project risks. In the study, 166 sets of geotechnical data Obtained from 35 boreholes including Standard Penetration Test, Limit Pressure, Liquid Limit, and Plastic Limit values, which are mostly utilized parameters in estimating project requirements, were used to estimate the geotechnical data distribution of the study field. In this context, firstly, the data was subjected to multi-parameter linear regression and variance analysis. Then, the obtained equations were implemented into a Monte Carlo Simulation, and probabilistic distributions of the geotechnical data of the field were simulated and corresponding to the 90% probability range, along with the minimum and maximum values at the 5% probability levels presented. Accordingly, while the average SPT N30 value is 42.86, but the highest occurrence rate is 50.81. For Net Limit Pressure, the average field data is 17.07 kg/cm2, with the maximum occurrence between 9.6 kg/cm2 and 13.7 kg/cm2. Similarly, the average Plastic Limit value is 22.32, while the most probable value is 20.6. The average Liquid Limit value is 56.73, with the highest probability at 54.48, as indicated in the statistical data distribution. Understanding the percentage distribution of data likely to be encountered in the project allows for accurate forecasting of both high and low probability scenarios, offering a significant advantage, particularly in ordering TBM requirements.

Design Study of Digital Map Architecture for AAV (미래형 항공기체(AAV)용 전자지도 아키텍처 설계 연구)

  • Kyung-Chul Choi;Ji-Hun Kim;Nak-Min Choi;Gyong-Hoon Baek
    • Journal of Advanced Navigation Technology
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    • v.28 no.4
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    • pp.393-399
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    • 2024
  • The digital map computer for advanced air vehicles (AAV) must be high-performance, lightweight, portable, and modular. It should receive data on terrain, weather, and obstacles from external modules to display digital maps accurately. This necessitates robust communication capabilities with external devices via an Ethernet interface and the ability to output digital map visuals clearly through an high-defintion multimedia Interface (HDMI) or digital visual interface (DVI) interface. This paper presents the design of both hardware and software architecture that fulfills these critical requirements for an AAV digital map system. Additionally, it establishes the minimum specifications needed and verifies the suitability of the designed digital map computer through rigorous performance measurements and testing. By ensuring these standards, the digital map computer can reliably support the complex navigational needs of AAV, enhancing operational efficiency and safety.

Reducing frame rate and pulse rate for routine diagnostic cerebral angiography: ALARA principles in practice

  • Arvin R. Wali;Sarath Pathuri;Michael G. Brandel;Ryan W. Sindewald;Brian R. Hirshman;Javier A. Bravo;Jeffrey A. Steinberg;Scott E. Olson;Jeffrey S. Pannell;Alexander Khalessi;David Santiago-Dieppa
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.26 no.1
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    • pp.46-50
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    • 2024
  • Objective: Diagnostic cerebral angiograms (DCAs) are widely used in neurosurgery due to their high sensitivity and specificity to diagnose and characterize pathology using ionizing radiation. Eliminating unnecessary radiation is critical to reduce risk to patients, providers, and health care staff. We investigated if reducing pulse and frame rates during routine DCAs would decrease radiation burden without compromising image quality. Methods: We performed a retrospective review of prospectively acquired data after implementing a quality improvement protocol in which pulse rate and frame rate were reduced from 15 p/s to 7.5 p/s and 7.5 f/s to 4.0 f/s respectively. Radiation doses and exposures were calculated. Two endovascular neurosurgeons reviewed randomly selected angiograms of both doses and blindly assessed their quality. Results: A total of 40 consecutive angiograms were retrospectively analyzed, 20 prior to the protocol change and 20 after. After the intervention, radiation dose, radiation per run, total exposure, and exposure per run were all significantly decreased even after adjustment for BMI (all p<0.05). On multivariable analysis, we identified a 46% decrease in total radiation dose and 39% decrease in exposure without compromising image quality or procedure time. Conclusions: We demonstrated that for routine DCAs, pulse rate of 7.5 with a frame rate of 4.0 is sufficient to obtain diagnostic information without compromising image quality or elongating procedure time. In the interest of patient, provider, and health care staff safety, we strongly encourage all interventionalists to be cognizant of radiation usage to avoid unnecessary radiation exposure and consequential health risks.

A comprehensive stress analysis in a functionally graded spherical pressure vessel: Thermo-elastic, elastoplastic and residual stress analysis

  • Thaier J. Ntayeesh;Mohsen Kholdi;Soheil Saeedi;Abbas Loghman;Mohammad Arefi
    • Steel and Composite Structures
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    • v.52 no.3
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    • pp.377-390
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    • 2024
  • Analyzing thermoelastic, elastoplastic, and residual stresses is pivotal for deepening our insights into material characteristics, particularly in the engineering of advanced materials like functionally graded materials (FGM). This research delves into these stress types within a thick-walled sphere composed of Al-SiC FGM, employing a detailed successive approximation method (SAM) to pinpoint stress distributions under varied loading scenarios. Our investigation centers on how the sphere's structure responds to different magnitudes of internal pressure. We discover that under various states-thermoelastic, elastoplastic, and residual-the radial stresses are adversely impacted, manifesting negative values due to the compressive nature induced by internal pressures. Notably, the occurrence of reverse yielding, observed at pressures above 410 MPa, merits attention due to its significant implications on the sphere's structural integrity and operational efficacy. Employing the SAM allows us to methodically explore the nuanced shifts in material properties across the sphere's thickness. This study not only highlights the critical behaviors of Al-SiC FGM spheres under stress but also emphasizes the need to consider reverse yielding phenomena to maintain safety and reliability in their application. We advocate for ongoing refinement of analytical techniques to further our understanding of stress behaviors in various FGM configurations, which could drive the optimized design and practical application of these innovative materials in diverse engineering fields.