bluuebunny/crossref_metadata_2025_split huggingface dataset:
Submission of Documents on the Pharmacovigilance System as Part of the Registration Dossier within the Framework of the EAEU Procedures: Analysis of Requirements and Typical Errors
Authors: Velts N. Yu. , Zhuravleva E. O. , Kutekhova G. V. , Tereshkina N. V. 
Published: October 2024

INTRODUCTION. Documents on the pharmacovigilance system of the marketing authorisation holder (MAH), including the Pharmacovigilance System Master File (PSMF) and the PSMF-based summary of the pharmacovigilance system (SPS), are a mandatory component of the registration dossier for a medicinal product. Applicants must submit and update these documents in strict accordance with the legislation of the Eurasian Economic Union (EAEU). Systematisation of the requirements for drafting and submitting documents on the pharmacovigilance system will help applicants streamline the documentation process.AIM. This study aimed to analyse the requirements for submitting either the PSMF or the SPS, depending on the EAEU marketing authorisation procedure, and to describe typical errors made by applicants when submitting these documents.DISCUSSION. The content of dossier documents on the pharmacovigilance system is regulated by the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (Decision No. 87 of the Council of the Eurasian Economic Commission (EEC) dated 3 November 2016), and their submission is governed by the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use (EEC Council Decision No. 78 dated 3 November 2016). MAHs are required to keep documents on the pharmacovigilance system and the corresponding registration dossiers up to date. This article summarises the specific requirements for submitting either the PSMF or the SPS, depending on the EAEU marketing authorisation procedure. Additionally, this article highlights typical errors made by MAHs when preparing documents on the pharmacovigilance system. According to the EAEU Rules of Good Pharmacovigilance Practice, the first application submitted for marketing authorisation of a medicinal product in the EAEU should include the PSMF, and subsequent applications should include the SPS as part of the registration dossier. Changes to the pharmacovigilance documents should be made in accordance with the classifier (EEC Council Decision No. 78 dated 3 November 2016).CONCLUSIONS. This analysis of the requirements for the PSMF or the SPS as part of various marketing authorisation procedures will facilitate compliance with the requirements of the EAEU legislative acts and ensure correct submission of necessary documents on the pharmacovigilance system by applicants. In addition, regulatory authorities will make fewer requests to submit missing information and grant more marketing authorisations.
Elemental Impurities in Gelatine Capsules: Human Health Risk Assessment
Authors: Schukin V. M. , Kuz'mina N. E. , Matveeva O. A. , Shvetsova Yu. N. , Zhigilei E. S. 
Published: October 2024

INTRODUCTION. This work continues the authors’ earlier study on gelatine capsule contamination with elemental impurities, which resulted in proposing a list of elements for standardisation. To ensure the safe use of medicinal products in this dosage form, it is necessary to develop criteria for the quantitative assessment of potential human health risks associated with elemental impurities in gelatine capsule shells.AIM. This study aimed to determine the permitted daily concentration (PDC) limits for elemental impurities in gelatine capsules from a risk-based pharmaceutical quality control perspective.MATERIALS AND METHODS. The authors analysed their previous experimental data, the relevant Russian State Standard (GOST), the requirements of the State Pharmacopoeia of the Russian Federation and leading world pharmacopoeias (USA, UK, EU, China, Japan, and India), and the scientific literature published from 1980 to 2023 on the content of elemental impurities (Al, As, Cd, Cu, Cr, Cr, Fe, Hg, Mn, Pb, and Zn) in gelatine capsule shells and medical gelatine.RESULTS. When standardising the content of elemental impurities in gelatine capsule shells, it is necessary to consider not only the toxicity of impurities but also their potential to compromise the quality of gelatine. Complexing elements (Cd, Cu, Hg, Cr, and Zn) can affect the quality of gelatine at subtoxic concentrations. For Cd, Cu, and Hg, the authors recommended using the PDC limits specified in GOST 23058-89 Gelatine. Raw materials for the medical industry. Specifications. For Cr and Zn, the authors recommended adhering to the PDC limits specified in the State Pharmacopoeia of the Russian Federation, edition XIV, Monograph 2.1.0099.18 Gelatine. Lead affects the quality of gelatine at concentrations above the toxicity threshold, and arsenic does not cause clustering of gelatine molecules. For Pb and As, the authors recommended using the PDC limits specified in the State Pharmacopoeia of the Russian Federation, edition XV, General Monograph 1.1.0040 Elemental impurities. The authors proposed a conversion factor to account for the complexing potential of Al when limiting its content in gelatine capsule shells. The authors recommended assessing the risks to human health associated with Mn intake with gelatine capsule shells indirectly by listing total heavy metals as a quality attribute to be controlled at the level of medical gelatine. The content of Fe should also be standardised at the raw material level.CONCLUSIONS. The content of elemental impurities in gelatine capsule shells should not exceed the following limits: 45 µg/g for Al, 1.5 µg/g for As, 0.03 µg/g for Cd, 10 µg/g for Cr, 15 µg/g for Cu, 0.05 µg/g for Hg, 0.5 µg/g for Pb, and 30 µg/g for Zn. The standardisation of these elements in gelatine capsule shells will prevent negative effects on the human body and shell quality.
The Role of Heat Treatment on Creep Rupture Ductility and its Underlying Metallurgical Mechanism of Forged Ni-based Superalloy
Authors: Arisue Ko , Akama Daichi , Takeda Yasunari , Yamamoto Ryuichi 
Published: October 2024

Abstract
For the safe operation of high temperature equipment, it is necessary to ensure creep rupture ductility of the components from the viewpoint of notch weakening. In this study, the effect of heat treatment conditions on creep rupture ductility was evaluated and its underlying metallurgical mechanism was investigated with using a forged Ni-based superalloy Udimet520. In order to improve the creep rupture ductility without lowering the creep rupture strength, it is important to increase both intragranular strength and intergranular strength in a balanced manner. For this purpose, it was clarified that 1) secondary γ' phase within grains should be kept fine and dense, 2) grain boundaries should be sufficiently covered by M23C6 carbide by increasing its phase fraction, and 3) tertiary γ' phase within grains should be redissolved before the start of creep. To obtain such a precipitate state, it is essential to appropriately select the cooling rate after solution treatment, stabilizing treatment and aging treatment conditions.
Acceleration of Material Acceptance and Industry Adoption of an Additively Manufactured Nickel-base Superalloy
Authors: Bridges Alex , Shingledecker John , Hussain Zara , Forster Jon , Nemeth Andre , Vogel Greg , O’Nora Nathan 
Published: October 2024

Abstract
The power industry has been faced with continued challenges around decarbonization and additive manufacturing (AM) has recently seen increased use over the last decade. The use of AM has led to significant design changes in components to improve the overall efficiency of gas turbines and more recently, hot-section components have been fabricated using AM nickel-base superalloys, which have shown substantial benefits. This paper will discuss and summarize extensive studies led by EPRI in a novel AM nickel-base superalloy (ABD·900-AM). A comprehensive high temperature creep testing study including &gt;67,000 hours of creep data concluded that ABD-900AM shows improved properties compared to similar ~35% volume fraction gamma prime strengthened nickel-base superalloys fabricated using additive methods. Several different creep mechanisms were identified and various factors influencing high temperature behavior, such as grain size, orientation, processing method, heat treatment, carbide structure, chemistry and porosity were explored. Additional studies on the printability, recyclability of powder, wide range of process parameters and several other factors have also been studied and results are summarized. A summary on the alloy -by-design approach and accelerated material acceptance of ABD-900AM through extensive testing and characterization is further discussed. Numerous field studies and examples of field use cases in ABD-900AM are also evaluated to showcase industry adoption of ABD-900AM.
Experimental and Numerical Characterization of High Temperature Deformation Behavior of 347H Stainless Steel
Authors: Joy Jobin K. , Rovinelli A. , Arul Kumar M. , Lebensohn R.A. , Capolungo L. , Ren Q.Q. , Yamamoto Y. , Poplawsky J.D. , Detrois M. , Jablonski P. 
Published: October 2024

Abstract
This study investigates how temperature affects the plasticity and thermal creep behavior of 347H stainless steel under uniaxial tension. The research combined experimental testing with advanced computational modeling. Two types of experiments were conducted: uniaxial tensile tests at temperatures from 100°C to 750°C using strain rates of ~10⁻⁴ s⁻¹, and creep tests at temperatures between 600°C and 750°C under various stress levels. These experimental results were used to develop and validate a new integrated mechanistic model that can predict material behavior under any loading condition while accounting for both stress and temperature effects. The model was implemented using a polycrystalline microstructure simulation framework based on elasto-viscoplastic Fast Fourier Transform (EVPFFT). It incorporates three key deformation mechanisms: thermally activated dislocation glide, dislocation climb, and vacancy diffusional creep. The model accounts for internal stress distribution within single crystals and considers how precipitates and solute atoms (both interstitial and substitutional) affect dislocation movement. After validation against experimental data, the model was used to generate Ashby-Weertman deformation mechanism maps for 347H steel, providing new insights into how microstructure influences the activation of different creep mechanisms.
Surface Characterization of Laser Clad Surfaces using Profile and Arial Techniques
Authors: Mandal Rahul , Cavill Simon , Bloomer Stephen , Carpenter Charles , Baufeld Bernd 
Published: October 2024

Abstract
Diode laser cladding (DLC) surfaces, valued in the nuclear industry for their wear resistance, corrosion protection, and oxidation resistance, present unique challenges in surface characterization compared to conventionally machined surfaces. While traditional machined surfaces exhibit predictable, periodic topographies that can be validated through simple linear profile measurements, DLC surfaces feature distinctive metal tracks with central peaks and inter-track troughs, creating a wave-like structure with randomly distributed spherical asperities. This complex topography cannot be adequately characterized by traditional single-trace sampling methods due to significant variations in localized features at peaks and troughs. To address this challenge, this study examines DLC surfaces produced under varying control parameters (laser power, head travel speed, powder feed rate, and track offset) using laser confocal microscopy. Both profile and areal surface measurements are compared to identify the most effective method for characterizing DLC surface structure and quality, providing a foundation for standardized quality assessment in industrial applications.
PAW and GTAW Welding Repair of HP/IP and Generator Rotors of a Steam Turbine for Electric Power Generation
Authors: Gómez Flórez Pablo Andrés , Betancur Alejandro Toro , Morales Galeano John Edison , Velásquez Jeisson Mejía 
Published: October 2024

Abstract
This work describes the repair procedure conducted on the High Pressure/Intermediate Pressure (HP/IP) and generator rotors of a 180 MW steam turbine General Electric (GE) - STAG207FA type D11 installed at La Sierra Thermoelectric Power Plant in Puerto Nare, Colombia. A lubricant supply failure at base load caused severe adhesive damage to the shafts in the bearing support areas and a permanent 3.5 mm bow at the HP/IP rotor mid span section, which required a complex intervention. The repair process began with the identification of the rotors manufacturing material through in-situ metallographic replicas, handheld XRF analysis and surface hardness measurements. Volumetric manual Gas Tungsten Arc Welding (GTAW) welding reconstruction of cracked areas followed by a surface overlay using GTAW and Plasma Arc Welding (PAW) welding processes were applied with a modular mechanized system, where a stress relief treatment through vibration was implemented with the help of computational simulations carried out to determine the fundamental frequencies of the rotors. Geometric correction of the HP/IP rotor mid span section was achieved thanks to the excitation of the rotor at some fundamental frequencies defined by the dynamic modeling and the use of heat treatment blankets at specific locations as well. Finally, after machining and polishing procedures, the power unit resumed operation eleven months after the failure and remains in service to the present date.
Life Extension of Gas Turbine Blades Made from Nickel-Based Superalloys
Authors: Gowreesan Vamadevan , Greaves Wayne 
Published: October 2024

Abstract
Gas turbine blades made from nickel-based superalloys, valued for their high temperature stability and creep resistance, undergo various forms of microstructural degradation during extended service at elevated temperatures that can ultimately lead to blade failure. To extend blade and turbine rotor life, Sulzer has developed evaluation and rejuvenation processes that include microstructural assessment and stress rupture testing of specimens from service-exposed blades. While stress rupture testing presents certain limitations and challenges in evaluating material condition, Sulzer has successfully rejuvenated hundreds of gas turbine blade sets across multiple superalloy types, including GTD 111, IN 738 LC, and U 500, demonstrating the effectiveness of heat treatment rejuvenation in improving microstructure and mechanical properties of service-degraded components.
Assessment of Cracking and Strain Monitoring of a Grade 92 Pipe from a Heat Recovery Steam Generator
Authors: Han Su Ji , Lee Han-sang , Jung Jinesung , Lee Gil Jae , Park Jin-Geun , Lee Seung Wook 
Published: October 2024

Abstract
In flexible operation with increased number of startup, shutdown, and load fluctuations, thermal fatigue damage is exacerbated along with existing creep damage in power plant pipe and pressure vessels. Recently, cracks were found in the start-up vent pipe branching from the reheat steam pipe within a heat recovery steam generator(HRSG) of J-class gas turbine, occurring in the P92 base material and repair welds. This pipe has been used at the power plant for about 10 years. Microstructural analysis of the cross-section indicated that the cracks were primarily due to thermal fatigue, growing within the grains without changing direction along the grain boundaries. To identify the damage mechanism and evaluate the remaining life, temperature and strain monitoring were taken from the damaged piping during startup and normal operation.
Creep Crack Growth on High and Low Creep Ductility Grade 91 Steel
Authors: Hanes Troy , Stephens Robert , Siefert John , Perrin Ian 
Published: October 2024

Abstract
This research compares creep crack growth behavior of two heats of creep strength enhanced ferritic (CSEF) steel, grade 91. These heats represent extremes of creep damage susceptibility, one heat exhibiting low creep ductility and the other high creep ductility. Creep crack growth tests were performed with compact tension specimens and were monitored with direct current potential drop and optical surface measurements. Load line displacement was measured throughout the duration of the tests. Specimens were sectioned, mounted, and analyzed using optical and scanning electron microscopy to assess the presence of oxidation, micro-cracking, creep damage, and void density. Tests were performed over a range of initial stress intensities on the low ductility material to investigate the impact of creep ductility. Metallurgical evidence and test data for each crack growth test was assessed to evaluate crack growth behavior linked to creep crack growth parameter (C*) and stress/creep damage distribution in the vicinity of the crack.
Impact of Three Additive Manufacturing Techniques on Microstructure and Creep Damage Development in Alloy 718
Authors: Harless Nikki , Shingledecker John , Stoodt Kyle , Cwiok Kevin , Kulkarni Anand 
Published: October 2024

Abstract
Inconel 718 is a nickel-based superalloy known for its excellent combination of high-temperature strength, corrosion resistance, and weldability. Additive Manufacturing (AM) has revolutionized traditional manufacturing processes by enabling the creation of complex and customized components. In this work, three prominent AM techniques: Laser-Based Powder Bed Fusion (PBF), Wire Direct Energy Deposition (DED), and Binder Jet (BJ) processes were explored. A thorough metallographic analysis and comparison of samples was conducted after short-term creep testing originating from each of the three aforementioned techniques in addition to wrought material. Detailed electron microscopy unveiled equiaxed grains in both BJ and wrought samples while PBF samples displayed elongated finer grain structures in the build direction, characteristic of PBF. The DED samples revealed a more bimodal grain distribution with a combination of smaller equiaxed grains accompanied by larger more elongated grains. When assessing the three processes, the average grain size was found to be larger in the BJ samples, while the PBF samples exhibited the most significant variation in grain and sub-grain size. Number density, size, and shape of porosity varied between all three techniques. Post-creep test observations in PBF samples revealed the occurrence of wedge cracking at the failure point, accompanied by a preference for grain boundary creep void formation while BJ samples exhibited grain boundary creep void coalescence and cracking at the failure location. In the DED samples, void formation was minimal however, it seemed to be more prevalent in areas with precipitates. In contrast, the wrought sample showed void formation at the failure site with a preference for areas with primary carbide formation. Despite BJ samples demonstrating similar or even superior rupture life compared to other AM techniques, a noteworthy reduction in rupture ductility was observed. While a coarse, uniform grain size is generally linked to enhanced creep resistance and rupture life, the combination of pre-existing voids along grain boundaries and the formation of new voids is hypothesized to accelerate rapid fracture, resulting in diminished ductility. This research shows careful consideration is needed when selecting an AM technology for high- temperature applications as creep behavior is sensitive to the large microstructural variations AM can introduce.
Evaluating Quality of Diffusion Bonded Material through Microscopy Measurement of Bondline Grain Growth
Authors: Jentz Ian , Desorcy Lukas , Bollinger Andrea 
Published: October 2024

Abstract
Simple and effective material examination methods are desired for the diffusion bonding process, so that bonding produced components, such as compact heat exchangers, can be used in nuclear applications. Optical microscopy of diffusion bond process samples is a quick way to examine diffusion bond-line microstructure and to evaluate material quality. The stacked nature of a diffusion bonded-block results in distinct regions of grain growth both at and away from the bond interface. Strong diffusion bond materials exhibit grain growth across the original bond interface plane, weak materials have little-to-no growth across. A series of 316H diffusion bonded specimens of differing quality and strength were examined using optical microscopy. The microstructure both at and away from the bond interface was examined over 15mm long sections of the bond-line. A metric for evaluating bond growth is proposed. This is defined as the Bond Line Growth Threshold (BLGT) and is evaluated as the percentage of the bond line with grains meeting the threshold. Here a fraction of the diffusion bond is considered bonded when its grains exceed a threshold of growth past the bond interface. The BLGT is determined through automated image processing methods.
Material Synthesis and Advanced Manufacturing Without Melting: Advantages of Bulk, High-Shear Processing
Authors: Komarasamy Mageshwari , Grant Glenn 
Published: October 2024

Abstract
The next generation of materials and assemblies designed to address challenges in power generation, such as molten salt or supercritical carbon dioxide thermal transfer systems, corrosion, creep/fatigue, and higher temperature operation, will likely be highly optimized for their specific performance requirements. This optimization often involves strict control over microstructure, including homogeneity, grain size, texture, and grain boundary phases, as well as precise alloy chemistry and homogeneity. These stringent requirements aim to meet the new demands for bulk mechanical performance and durability. Some advanced materials, like oxide-dispersion strengthened or high-entropy alloys, necessitate specialized synthesis, fabrication, or welding/joining processes. Traditional methods that involve melting and solidifying can compromise the optimized microstructure of these materials, making non-melting synthesis and fabrication methods preferable to preserve their advanced characteristics. This paper presents examples where solid-phase, high-shear processing has produced materials and semi-finished products with superior performance compared to those made using conventional methods. While traditional processing often relies on thermodynamics-driven processes, such as creating precipitate phases through prolonged heat treatment, high-shear processing offers kinetics-driven, non-equilibrium alternatives that can yield high-performance microstructures. Additionally, examples are provided that demonstrate the potential for more cost-effective manufacturing routes due to fewer steps or lower energy requirements. This paper highlights advances in high-shear extrusion processing, including friction extrusion and shear-assisted processing and extrusion, as well as developments in solid-phase welding techniques like friction stir welding for next-generation power plant materials.
Wire Arc Additive Manufacturing of Creep Strength Enhanced Ferritic Steels and Nickel Alloys
Authors: Krein Ronny , Sushko Vadym 
Published: October 2024

Abstract
Additive manufacturing is a groundbreaking manufacturing method that enables nearly lossless processing of high-value materials and produces complex components with a level of flexibility that traditional methods cannot achieve. Wire arc additive manufacturing (WAAM), utilizing a conventional welding process such as gas metal arc welding, is one of the most efficient additive manufacturing technologies. The WAAM process is fully automated and guided by CAD/CAM systems on robotic or CNC welding platforms. This paper explores the fundamental concepts and metallurgical characteristics of WAAM. It focuses primarily on the mechanical properties of printed sample structures made from P91, X20, and alloys 625 and 718 wire feedstock. The study particularly addresses the anisotropy of mechanical properties through both short-term and long-term testing, comparing these results to materials processed using conventional methods.