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NMR standardization approach that uses the 2H integral of deuterated solvent for quantitative multinuclear analysis of pharmaceuticals is described. As a proof of principle, the existing NMR procedure for the analysis of heparin products according to US Pharmacopeia monograph is extended to the determination of Na+ and Cl- content in this matrix. Quantification is performed based on the ratio of a 23Na (35Cl) NMR integral and 2H NMR signal of deuterated solvent, D2O, acquired using the specific spectrometer hardware. As an alternative, the possibility of 133Cs standardization using the addition of Cs2CO3 stock solution is shown. Validation characteristics (linearity, repeatability, sensitivity) are evaluated. A holistic NMR profiling of heparin products can now also be used for the quantitative determination of inorganic compounds in a single analytical run using a single sample. In general, the new standardization methodology provides an appealing alternative for the NMR screening of inorganic and organic components in pharmaceutical products.
Retinal vessels are similar to cerebral vessels in their structure and function. Moderately low oscillation frequencies of around 0.1 Hz have been reported as the driving force for paravascular drainage in gray matter in mice and are known as the frequencies of lymphatic vessels in humans. We aimed to elucidate whether retinal vessel oscillations are altered in Alzheimer's disease (AD) at the stage of dementia or mild cognitive impairment (MCI). Seventeen patients with mild-to-moderate dementia due to AD (ADD); 23 patients with MCI due to AD, and 18 cognitively healthy controls (HC) were examined using Dynamic Retinal Vessel Analyzer. Oscillatory temporal changes of retinal vessel diameters were evaluated using mathematical signal analysis. Especially at moderately low frequencies around 0.1 Hz, arterial oscillations in ADD and MCI significantly prevailed over HC oscillations and correlated with disease severity. The pronounced retinal arterial vasomotion at moderately low frequencies in the ADD and MCI groups would be compatible with the view of a compensatory upregulation of paravascular drainage in AD and strengthen the amyloid clearance hypothesis.
Biomedical applications of magnetic nanoparticles (MNP) fundamentally rely on the particles’ magnetic relaxation as a response to an alternating magnetic field. The magnetic relaxation complexly depends on the interplay of MNP magnetic and physical properties with the applied field parameters. It is commonly accepted that particle core size is a major contributor to signal generation in all the above applications, however, most MNP samples comprise broad distribution spanning nm and more. Therefore, precise knowledge of the exact contribution of individual core sizes to signal generation is desired for optimal MNP design generally for each application. Specifically, we present a magnetic relaxation simulation-driven analysis of experimental frequency mixing magnetic detection (FMMD) for biosensing to quantify the contributions of individual core size fractions towards signal generation. Applying our method to two different experimental MNP systems, we found the most dominant contributions from approx. 20 nm sized particles in the two independent MNP systems. Additional comparison between freely suspended and immobilized MNP also reveals insight in the MNP microstructure, allowing to use FMMD for MNP characterization, as well as to further fine-tune its applicability in biosensing.
Frequency mixing magnetic detection (FMMD) has been widely utilized as a measurement technique in magnetic immunoassays. It can also be used for the characterization and distinction (also known as “colourization”) of different types of magnetic nanoparticles (MNPs) based on their core sizes. In a previous work, it was shown that the large particles contribute most of the FMMD signal. This leads to ambiguities in core size determination from fitting since the contribution of the small-sized particles is almost undetectable among the strong responses from the large ones. In this work, we report on how this ambiguity can be overcome by modelling the signal intensity using the Langevin model in thermodynamic equilibrium including a lognormal core size distribution fL(dc,d0,σ) fitted to experimentally measured FMMD data of immobilized MNPs. For each given median diameter d0, an ambiguous amount of best-fitting pairs of parameters distribution width σ and number of particles Np with R2 > 0.99 are extracted. By determining the samples’ total iron mass, mFe, with inductively coupled plasma optical emission spectrometry (ICP-OES), we are then able to identify the one specific best-fitting pair (σ, Np) one uniquely. With this additional externally measured parameter, we resolved the ambiguity in core size distribution and determined the parameters (d0, σ, Np) directly from FMMD measurements, allowing precise MNPs sample characterization.
Nuclear magnetic resonance (NMR) spectrometric methods for the quantitative analysis of pure heparin in crude heparin is proposed. For quantification, a two-step routine was developed using a USP heparin reference sample for calibration and benzoic acid as an internal standard. The method was successfully validated for its accuracy, reproducibility, and precision. The methodology was used to analyze 20 authentic porcine heparinoid samples having heparin content between 4.25 w/w % and 64.4 w/w %. The characterization of crude heparin products was further extended to a simultaneous analysis of these common ions: sodium, calcium, acetate and chloride. A significant, linear dependence was found between anticoagulant activity and assayed heparin content for thirteen heparinoids samples, for which reference data were available. A Diffused-ordered NMR experiment (DOSY) can be used for qualitative analysis of specific glycosaminoglycans (GAGs) in heparinoid matrices and, potentially, for quantitative prediction of molecular weight of GAGs. NMR spectrometry therefore represents a unique analytical method suitable for the simultaneous quantitative control of organic and inorganic composition of crude heparin samples (especially heparin content) as well as an estimation of other physical and quality parameters (molecular weight, animal origin and activity).
In the Laser Powder Bed Fusion (LPBF) process, parts are built out of metal powder material by exposure of a laser beam. During handling operations of the powder material, several influencing factors can affect the properties of the powder material and therefore directly influence the processability during manufacturing. Contamination by moisture due to handling operations is one of the most critical aspects of powder quality. In order to investigate the influences of powder humidity on LPBF processing, four materials (AlSi10Mg, Ti6Al4V, 316L and IN718) are chosen for this study. The powder material is artificially humidified, subsequently characterized, manufactured into cubic samples in a miniaturized process chamber and analyzed for their relative density. The results indicate that the processability and reproducibility of parts made of AlSi10Mg and Ti6Al4V are susceptible to humidity, while IN718 and 316L are barely influenced.
Additive Manufacturing (AM) of metallic workpieces faces a continuously rising technological relevance and market size. Producing complex or highly strained unique workpieces is a significant field of application, making AM highly relevant for tool components. Its successful economic application requires systematic workpiece based decisions and optimizations. Considering geometric and technological requirements as well as the necessary post-processing makes deciding effortful and requires in-depth knowledge. As design is usually adjusted to established manufacturing, associated technological and strategic potentials are often neglected. To embed AM in a future proof industrial environment, software-based self-learning tools are necessary. Integrated into production planning, they enable companies to unlock the potentials of AM efficiently. This paper presents an appropriate methodology for the analysis of process-specific AM-eligibility and optimization potential, added up by concrete optimization proposals. For an integrated workpiece characterization, proven methods are enlarged by tooling-specific figures.
The first stage of the approach specifies the model’s initialization. A learning set of tooling components is described using the developed key figure system. Based on this, a set of applicable rules for workpiece-specific result determination is generated through clustering and expert evaluation. Within the following application stage, strategic orientation is quantified and workpieces of interest are described using the developed key figures. Subsequently, the retrieved information is used for automatically generating specific recommendations relying on the generated ruleset of stage one. Finally, actual experiences regarding the recommendations are gathered within stage three. Statistic learning transfers those to the generated ruleset leading to a continuously deepening knowledge base. This process enables a steady improvement in output quality.
Gamification applications are on the rise in the manufacturing sector to customize working scenarios, offer user-specific feedback, and provide personalized learning offerings. Commonly, different sensors are integrated into work environments to track workers’ actions. Game elements are selected according to the work task and users’ preferences. However, implementing gamified workplaces remains challenging as different data sources must be established, evaluated, and connected. Developers often require information from several areas of the companies to offer meaningful gamification strategies for their employees. Moreover, work environments and the associated support systems are usually not flexible enough to adapt to personal needs. Digital twins are one primary possibility to create a uniform data approach that can provide semantic information to gamification applications. Frequently, several digital twins have to interact with each other to provide information about the workplace, the manufacturing process, and the knowledge of the employees. This research aims to create an overview of existing digital twin approaches for digital support systems and presents a concept to use digital twins for gamified support and training systems. The concept is based upon the Reference Architecture Industry 4.0 (RAMI 4.0) and includes information about the whole life cycle of the assets. It is applied to an existing gamified training system and evaluated in the Industry 4.0 model factory by an example of a handle mounting.
Virtual Reality (VR) offers novel possibilities for remote training regardless of the availability of the actual equipment, the presence of specialists, and the training locations. Research shows that training environments that adapt to users' preferences and performance can promote more effective learning. However, the observed results can hardly be traced back to specific adaptive measures but the whole new training approach. This study analyzes the effects of a combined point and leveling VR-based gamification system on assembly training targeting specific training outcomes and users' motivations. The Gamified-VR-Group with 26 subjects received the gamified training, and the Non-Gamified-VR-Group with 27 subjects received the alternative without gamified elements. Both groups conducted their VR training at least three times before assembling the actual structure. The study found that a level system that gradually increases the difficulty and error probability in VR can significantly lower real-world error rates, self-corrections, and support usages. According to our study, a high error occurrence at the highest training level reduced the Gamified-VR-Group's feeling of competence compared to the Non-Gamified-VR-Group, but at the same time also led to lower error probabilities in real-life. It is concluded that a level system with a variable task difficulty should be combined with carefully balanced positive and negative feedback messages. This way, better learning results, and an improved self-evaluation can be achieved while not causing significant impacts on the participants' feeling of competence.