Quality Control Of Products Research Articles

Ultra-high performance liquid chromatography-tandem mass spectrometry assay for simultaneous determination of 22 marker compounds in traditional herbal medicine Ojeoksan

Traditional herbal medicines (THMs) have long been in use worldwide and are considered safe for use as tonics or complementary treatments for many diseases. Advanced quality control methods for THMs are required in the regulatory framework of modern medicines. In this study, an ultra-high performance liquid chromatography-tandem mass spectrometry assay was established for the simultaneous determination of 22 marker compounds in Ojeoksan (OJS), which is composed of 15 herbal substances. All marker compounds were analyzed within 20min and successfully identified via scheduled multiple reaction monitoring. The method validation revealed excellent performance characteristics of the method such as specificity, linearity, sensitivity, precision, and accuracy, demonstrating its suitability for intended use. The developed method was applied to samples of commercial OJS tablet and soft-extract dosage forms. The 14 marker compounds corresponding to 12 component herbal substances were determined in the samples; ephedirine, albiflorin, paeoniflorin, ferulic acid, hesperidine, neohesperidin, cinnamic acid, platycodin D, 6-gingerol, atractylenolide III, glycyrrhizin, honokiol, decursin, and magnolol. A fast and easy assay method with sufficient discrimination power was established. As a novel assay, this method can contribute to the quality control of OJS products.

Compositional analysis of multilayered plastic constituents and constituent mixtures using benchtop 1H NMR spectroscopy.

Multilayered plastics are widely used in food packaging and other commercial applications due to their tailored functional properties. By layering different polymers, the multilayered composite material can have enhanced mechanical, thermal, and barrier properties compared to a single plastic. However, there is a significant need to recycle these multilayer plastics, but their complex structure offers significant challenges to their successful recycling. Ultimately, the use and recycling of these complex materials requires the ability to characterize the composition and purity as a means of quality control for both production and recycling processes. New advances and availability of low-field benchtop 1H NMR spectrometers have led to increasing interest in its use for characterization of multicomponent polymers and polymer mixtures. Here, we demonstrate the capability of low-field benchtop 1H NMR spectroscopy for characterization of three common polymers associated with multilayered packaging systems (low-density polyethylene [LDPE], ethylene vinyl alcohol [EVOH], and Nylon) as well as their blends. Calibration curves are obtained for determining the unknown composition of EVOH and Nylon in multilayered packaging plastics using both the EVOH hydroxyl peak area and an observed peak shift, both yielding results in good agreement with the prepared sample compositions. Additionally, comparison of results extracted for the same samples characterized by our benchtop spectrometer and a 500-MHz spectrometer found results to be consistent and within 2wt% on average. Overall, low-field benchtop 1H NMR spectroscopy is a reliable and accessible tool for characterization of these polymer systems.

Utilising LANDHYPERNET data products over a deciduous broadleaf forest to validate Sentinel-2 and Landsat surface reflectance products

This paper demonstrates the use of a novel, autonomous hyperspectral surface reflectance data collected at Wytham Woods, United Kingdom (WWUK) as part of the LANDHYPERNET network for the validation of multispectral data from Sentinel-2, Landsat 8 and Landsat 9. The deployment of the HYPSTAR instrument at the site and the corresponding quality control of the data products is described. In addition, a methodology based upon metrological principles is outlined showing the propagation of uncertainties from the LANDHYPERNET and satellite data products to enable conformity testing of the satellite products using the satellite mission requirements. A total of 9 matchups are found for satellite validation at the site, where there is a cloud-free satellite scene and a corresponding LANDHYPERNET sequence, which has passed all quality checks, within two hours of the overpass. An analysis of the impact of the spatial variability of the site is presented and can account for up to 40% of the uncertainty associated with the in-situ surface reflectance data. There is no systematic bias in the Bottom-Of-Atmosphere reflectance data obtained from the LANDHYPERNET data in comparison to the satellite data. In the best case, differences of less than 2% are found for certain spectral bands. However, in the worst cases, relatively large differences are found which exceed 100%, this is affected by the relatively low reflectance values found in the visible bands. These differences could be caused by the spatial and temporal mismatch between the in-situ and satellite measurement, or due to shadowing caused by the flux tower. Further data quality control and assurance is needed to best choose data sets suitable for satellite validation. Incorporating a Bidirectional Reflectance Distribution Function model into the processing chain for the forest canopy is recommended. Overall, although there are areas to further characterise, the site provides a useful benchmark for which to develop techniques for validation of satellite surface reflectance products over a challenging environment.

Model-based process intensification of deep eutectic solvent treatment of eucalyptus slabs for lignin extraction and pulp production

This work revealed the reaction characteristics in the delignification process of eucalyptus slabs catalyzed by acidic deep eutectic solvent (benzyltriethylammonium chloride/formic acid) from the perspective of heterogeneous reactions. The limitation of internal diffusion on delignification process cannot be ignored. Afterwards, a kinetic model based on cell wall structure was proposed to describe the relationship between the delignification degree and reaction conditions, and it also hold excellent predictive ability for lignin removal, carbohydrate retention and solid residue yield. Compared with other reported kinetic models, this novel model not only took into account all operational parameters of reaction process, but also can be applied to the entire reaction process without the need for segmentation. Besides, an essential requirement based on the developed model was a 44.40 wt% formic acid concentration and a temperature of 130 °C, when the purpose of DES treatment was pulping. Generally, this work could provide guidance on process adjustments and product quality control during the DES processing.

Analysis of printing product quality control using the seven tools method on CV. XYZ

This research aims to identify the elements that influence product flaws in printing outcomes, comprehend the findings of a seven-tool analysis, and establish what can be done about the defects that exceed the limits applied. This descriptive study employs both qualitative and quantitative methodologies. This study was investigated using the Seven Tools analysis. This study's findings are research that can be conducted using the seven-tool method. The conclusion that can be taken is about four factors that affect product defect, obtained the analysis of seven tools to make quality control and improve human, machine, work methods, and raw materials.

Electro-Optics Properties of Intact Cocoa Beans based on Near Infrared Technology

This study encapsulates the efficient prediction of moisture content in cocoa beans through Near Infrared Spectroscopy (NIRS) and Partial Least Squares (PLS) regression, showcasing a strong model fit with a high R square value of 0.92 and low Root Mean Square Error (RMSE) of 0.36% in calibration; these values underscore the model's accurate estimation of moisture levels. In the realm of electro-optics properties, this success highlights NIRS's capability in assessing key attributes like moisture content in cocoa beans based on their unique spectral signatures, emphasizing the technology's role in quality control for chocolate production. Furthermore, the precise predictions align with the broader objective of leveraging NIRS to evaluate and optimize the electro- optics properties of cocoa beans, fostering informed decision-making for enhanced processing and quality assurance in the cocoa industry.

THE INFLUENCE OF THE PRODUCTION PROCESS AND QUALITY CONTROL ON THE QUALITY OF BANANA CHIP PRODUCTS AT ASKHA JAYA CHIP SHOP

Currently, the MSME area in the country is experiencing a quite challenging atmosphere amid the change of business areas that continue to become complex. In a tight economic competition like today, industry actors are required to sort out several options, one of which is prioritizing quality to achieve a wider market share, one of which is at the Askha Jaya Banana Chip Store. The challenge that takes place in the Askha Jaya Banana Chips business is that there is still a process of creating manual methods, and the packaging problems that exist are also still very limited is by using hands alias manual, so that there are still often errors or defective objects or bad objects that take place after the production process. Process means the methods, tactics, and mechanisms in which current resources, hardware, materials, and assets are thoroughly transformed to achieve results. Quality control is a mechanism and structured exercises / activities carried out to achieve, follow and work on the nature of goods and services in accordance with predetermined guidelines and can meet consumer loyalty. The purpose of this research is to recognize the influence of variables on the Askha Jaya Banana Chip Store. This research method uses quantitative descriptive research, with a sample of 35. Then the information is processed using SPSS version 22. The results of the research show that the production process and quality control together have a positive and significant effect on product quality at the Askha Jaya Banana Chip Store.

Characterization of flavor-related compounds and sensory profiles of four fermented fish products prepared from silver rasbora (Rasbora argyrotaenia) and anchovy (Stolephorus sp.)

Fermented fish products are grouped into salt and salt-carbohydrate types based on the fermentation substrate. A series of biochemical reactions on the substrate affects the flavor characteristics of the resulting products. This study compared the amino acids, fatty acids, and volatile compound profiles of four fermented fish products: bekasam, rusip, fish paste, and fish sauce made from silver rasbora and anchovy. The quantitative descriptive analysis (QDA) was carried out to determine the sensory profiles of those products. The results indicated that rusip and bekasam, which belong to salt-carbohydrate fermented fish, were characterized as high in arginine, stearic, capric, and oleic acid, with ketones, lactones, and fatty acid derivative compounds dominating their flavor profiles. The flavor profile of fish paste was characterized by high concentrations of aldehydes such as 3- methylbutanal and hexanal, whereas that of fish sauce was characterized by large concentrations of pyrazine and aromatic compounds. Based on the findings of the QDA, no significant difference was observed within the sensory variables of fish sauce and fish paste prepared from anchovy and silver rasbora, indicating that both fish are equally usable as raw materials. Whereas different saltiness was identified in both rusip and bekasam prepared from anchovy and rasbora. The results of PCA on QDA data separated fermented fish type 1 from the type 2. Fermented fish type 1 was more correlated with umami and sweet taste, while type 2 was correlated with fishy, salty, sour, and astringent taste. The result is useful as a basis for further product development and quality control.

A Review of Artificial Intelligence Techniques for Quality Control in Semiconductor Production

A Review of Artificial Intelligence Techniques for Quality Control in Semiconductor Production

Development of a sustainable procedure for smartphone-based colorimetric determination of benzalkonium chloride in pharmaceutical preparations

A sustainable procedure offering green, simple, and rapid analysis was developed to determine benzalkonium chloride (BKC) in pharmaceutical preparations. The determination using smartphones was based on the ion pair colorimetric reaction with bromothymol blue (BTB), which produces a yellow color. The intensity of the product color, which is proportional to the concentration of BKC, was detected and evaluated using a smartphone camera and an image processing application. The procedure was performed in a microliter and was rapidly detected within 1 min after incubation. This offered high throughput at 28 samples per well plate in duplicate. Linear calibration, which was a plot of BKC concentrations and relative red intensities, was in the range of 2.0–24.0 μg/mL with an R2 of 0.997. The limits of detection (LOD) and quantitation (LOQ) were 1.0 and 3.2 μg/mL, respectively. This work was successful in applying it to pharmaceutical materials, disinfectant products, and pharmaceutical products containing BKC. It was discovered that the concentrations of BKC as an active ingredient in pharmaceutical materials were 82% w/v, whereas those in disinfectant products ranged from 0.4 to 2.1% w/v. In pharmaceutical products, ophthalmic drops and nasal sprays contain BKC as preservatives in the 0.01–0.02, and the 0.02% w/v, respectively. The results obtained by the proposed procedure compared with a reference titration method showed no significant differences at a 95% confidence level with 1.2–3.4% RSDs. This promotes the efficiency of pharmaceutical preparations regarding infection prevention and control by ensuring that available disinfectants contain a sufficient concentration of BKC. Additionally, this improves the efficiency of pharmaceutical preparations for quality control of pharmaceutical products by ensuring that the available preservatives maintain a sufficient concentration throughout the lifespan of the products.

Assessment of the Conformation Stability and Glycosylation Heterogeneity of Lactoferrin by Native Mass Spectrometry.

Lactoferrin (LTF) has diverse biological activities and is widely used in functional foods and active additives. Nevertheless, evaluating the proteoform heterogeneity, conformational stability, and activity of LTF remains challenging during its production and storage processes. In this study, we describe the implementation of native mass spectrometry (nMS), glycoproteomics, and an antimicrobial activity assay to assess the quality of LTF. We systematically characterize the purity, glycosylation heterogeneity, conformation, and thermal stability of LTF samples from different sources and transient high-temperature treatments by using nMS and glycoproteomics. Meanwhile, the nMS peak intensity and antimicrobial activity of LTF samples after heat treatment decreased significantly, and the two values were positively correlated. The nMS results provide essential molecular insights into the conformational stability and glycosylation heterogeneity of different LTF samples. Our results underscore the great potential of nMS for LTF quality control and activity evaluation in industrial production.

Applying the Taguchi Method to Improve Key Parameters of Extrusion Vacuum-Forming Quality.

This research investigates the control of thickness and weight in plastic extrusion vacuum-thermoforming products to identify optimal key parameters for cost reduction and energy savings. The initial step involves identifying crucial influencing factors. In this step, the Delphi technique was employed through a questionnaire administered to a panel of expert scholars to ensure minimal error and maximal reliability in determining key influencing factors. Consensus was sought to establish appropriateness and consistency. Subsequently, the Taguchi method was applied for quality design and planning of the extrusion vacuum-forming process. The experimental design parameters were selected using an L18 (21 × 37) orthogonal array, and the desired quality characteristics were determined. Comparative analysis of quantitative production data from two consecutive experiments was conducted, and based on F-values and contribution analysis, the combination of control factors maximizing the Signal-to-Noise (S/N) ratio was identified. The objective is to seek optimal parameters for improving the quality of the plastic polypropylene (PP cup lid) manufacturing process, reducing process variability, and identifying the most robust production conditions. Through multiple actual production prediction experiments, it was determined that five control factors, "polypropylene new material ratio," "T-die lips adjustment thickness", "mirror wheel temperature stability", "molding vacuum pressure time", and "forming mold area design", contribute to the maximization of the S/N ratio, i.e., minimizing variability. Statistical validation confirms a significant improvement in product quality and weight control. Noteworthily, the quality control model and experimental design parameters established in this study are also applicable to other plastic products and bio-based materials, such as PET, HIPS, and biodegradable PLA lids with added calcium carbonate. The results of the experimental production demonstrate its ability to consistently control product weight within the range of 3.4 ± 0.1 g, approaching the specified tolerance limits. This capability results in approximately 2.6% cost savings in product weight, contributing significantly to achieving a company's KPI goals for environmental conservation, energy efficiency, and operational cost reduction. Therefore, the findings of this study represent a substantial and tangible contribution.

Development and Application of Control Concepts for Twin-Screw Wet Granulation in the ConsiGmaTM-25: Part 1 Granule Composition

Continuous manufacturing of pharmaceuticals offers several benefits, such as increased production efficiency, enhanced product quality control, and lower environmental footprint. To fully exploit these benefits, standard operation mode (production processes with no or minimal disturbance mitigation measures) should be supported by adopting novel quality-by-control (QbC) methodologies. The paper at hand is the first part of a study focused on developing QbC algorithms for optimizing twin-screw wet granulation in the industrial manufacturing line ConsiGmaTM-25, specifically addressing granule composition.This work relies on previously established process-analytical-technology (PAT) equipment for real-time monitoring of the granule composition, i.e., the active pharmaceutical ingredient (API) and liquid content in wet granules. The developed control platform integrates model-based process control algorithms that aim to keep the API- and liquid content at target values through real-time adjustments of the process parameters. Furthermore, the platform integrates a digital operator assistant, which aims to detect and classify granulation disturbances and provides messages and instructions for the plant operator.The present manuscript systematically outlines all design steps from the development phase in the simulation environment to the final real system application and validation. The control platform’s performance is demonstrated through selected test scenarios on the ConsiGmaTM-25 manufacturing line. The obtained results indicate improved disturbance robustness and an increase in intermediate/final product quality (compared to conventional operating modes): The process control algorithms successfully maintained the API- and liquid content at target values despite process disturbances. Furthermore, realistic disturbances (feeder, pump, and material) were accurately detected and classified by the digital assistant algorithm. The information was provided through a user interface, offering real-time support for plant personnel.

Efficient residual network using hyperspectral images for corn variety identification.

Corn seeds are an essential element in agricultural production, and accurate identification of their varieties and quality is crucial for planting management, variety improvement, and agricultural product quality control. However, more than traditional manual classification methods are needed to meet the needs of intelligent agriculture. With the rapid development of deep learning methods in the computer field, we propose an efficient residual network named ERNet to identify hyperspectral corn seeds. First, we use linear discriminant analysis to perform dimensionality reduction processing on hyperspectral corn seed images so that the images can be smoothly input into the network. Second, we use effective residual blocks to extract fine-grained features from images. Lastly, we detect and categorize the hyperspectral corn seed images using the classifier softmax. ERNet performs exceptionally well compared to other deep learning techniques and conventional methods. With 98.36% accuracy rate, the result is a valuable reference for classification studies, including hyperspectral corn seed pictures.

Non-Microbiological Mycobacterial Detection Techniques for Quality Control of Biological Products: A Comprehensive Review.

Mycobacteria can be one of the main contaminants of biological products, and their presence can have serious consequences on patients' health. For this reason, the European Pharmacopoeia mandates the specific testing of biological products for mycobacteria, a critical regulatory requirement aimed at ensuring the safety of these products before they are released to the market. The current pharmacopeial reference, i.e., microbial culture method, cannot ensure an exhaustive detection of mycobacteria due to their growth characteristics. Additionally, the method is time consuming and requires a continuous supply of culture media, posing logistical challenges. Thus, to overcome these issues, pharmaceutical industries need to consider alternative non-microbiological techniques to detect these fastidious, slow-growing contaminating agents. This review provides an overview of alternative methods, which could be applied within a quality control environment for biological products and underlines their advantages and limitations. Nucleic acid amplification techniques or direct measurement of mycobacteria stand out as the most suitable alternatives for mycobacterial testing in biological products.

The Prediction of Quality Parameters of Craft Beer with FT-MIR and Chemometrics.

Beer is one of the oldest and most known alcoholic beverages whose organoleptic characteristics are the attributes that the consumer seeks, which is why it is essential to ensure proper quality control of the final product. Fourier transform mid-infrared (FT-MIR) spectroscopy coupled with multivariate analysis can be an alternative to traditional methods to predict quality parameters in craft beer. This study aims to develop prediction models based on FT-MIR spectroscopy to simultaneously quantify quality parameters (color, specific gravity, alcohol volume, bitterness, turbidity, pH, and total acidity) in craft beer. Additionally, principal component analysis (PCA) was applied, and it was possible to classify craft beer samples according to their style. Partial least squares (PLS1) developed the best predictive model by obtaining higher R2c (0.9999) values and lower standard error of calibration (SEC: 0.01-0.11) and standard error of prediction (SEP: 0.01-0.14) values in comparison to the models developed with the other algorithms. Specific gravity could not be predicted due to the low variability in the values. Validation and prediction with external samples confirmed the predictive capacity of the developed model. By making a comparison to traditional techniques, FT-MIR coupled with multivariate analysis has a higher advantage, since it is rapid (approximately 6 min), efficient, cheap, and eco-friendly because it does not require the use of solvents or reagents, representing an alternative to simultaneously analyzing quality parameters in craft beer.

Assessment of the botanical origin of Saudi Arabian honey samples to identify pollen with chromatographic tools and packing and storage.

The increasing demand for honey purification and authentication necessitates the global utilization of advanced processing tools. Common honey processing techniques, such as chromatography, are commonly used to assess the quality and quantity of valuable honey. In this study, 15 honey samples were authenticated using HPLC and GC-MS chromatographic methods to analyze their pollen spectrum. Various monofloral honey samples were collected, including Acacia, Hypoestes, Lavandula, Tamarix, Trifolium, and Ziziphus species, based on accurate identification by apiarists in 2023 from the Kingdom of Saudi Arabia. Honey analysis revealed the extraction of pollen from 20 different honeybee floral species. Pollen identified from honey samples using advanced chromatographic tools revealed dominant vegetation resources: Ziziphus species (23%), Acacia species (25%), Tamarix species (34%), Lavandula species (26%), Hypoestes species (34%), and Trifolium species (31%). This study uses HPLC to extract phenolic compounds, revealing dominant protocatechuic acid (4.71 mg g-1), and GC-MS to analyze organic compounds in honey pollen. Specifically, 2-dodecanone was detected with a retention time of 7.34 min. The utilization of chromatographic tools in assessing honey samples for pollen identification provides a reliable and efficient method for determining their botanical origins, thereby contributing to the quality control and authentication of honey products.

Stability indicating ion-pair reversed-phase liquid chromatography method for modified mRNA

Modified messenger RNA (mRNA) represents a rapidly emerging class of therapeutic drug product. Development of robust stability indicating methods for control of product quality are therefore critical to support successful pharmaceutical development. This paper presents an ion-pair reversed-phase liquid chromatography (IP-RPLC) method to characterise modified mRNA exposed to a wide set of stress-inducing conditions, relevant for pharmaceutical development of an mRNA drug product. The optimised method could be used for separation and analysis of large RNA, sized up to 1000 nucleotides. Column temperature, mobile phase flow rate and ion-pair selection were each studied and optimised. Baseline separations of the model RNA ladder sample were achieved using all examined ion-pairing agents. We established that the optimised method, using 100 mM Triethylamine, enabled the highest resolution separation for the largest fragments in the RNA ladder (750/1000 nucleotides), in addition to the highest overall resolution for the selected modified mRNA compound (eGFP mRNA, 996 nucleotides). The stability indicating power of the method was demonstrated by analysing the modified eGFP mRNA, upon direct exposure to heat, hydrolytic conditions and treatment with ribonucleases. Our results showed that the formed degradation products, which appeared as shorter RNA fragments in front of the main peak, could be well monitored, using the optimised method, and the relative stability of the mRNA under the various stressed conditions could be assessed.

UV-Visible Spectroscopy: A Review on its Pharmaceutical and Bio-allied Sciences Applications

Abstract: Ultraviolet-Visible (UV-Vis) spectroscopy has emerged as a powerful analytical tool with diverse applications in pharmaceutical and bio-allied sciences. This article provides a comprehensive overview of the extensive utility of UV-Vis spectroscopy, emphasizing its pivotal role in characterizing and analyzing various compounds critical for drug development and bio-allied research. In the pharmaceutical sector, UV-Vis spectroscopy is a fundamental technique for quantifying the concentrations of active pharmaceutical ingredients (APIs) in formulations. Its non-destructive nature and high sensitivity make it an indispensable tool for quality control, ensuring the consistency and potency of pharmaceutical products. Furthermore, this technique has been employed in the study of drug-receptor interactions to elucidate the molecular mechanisms underlying therapeutic effects. In bio-allied applications, UV-Vis spectroscopy is used to analyze biomolecules like proteins, nucleic acids, and enzymes. This technique allows for the study of protein conformational changes, DNA structure, and enzymatic activity, offering crucial insights into fundamental biological processes. Additionally, UV-Vis spectroscopy aids in determining biomarker concentrations, assisting in the early diagnosis and monitoring of various diseases. This article also explores recent advancements in UV-Vis spectroscopy, including the integration of nanomaterials and computational approaches to enhance sensitivity and selectivity. Moreover, it discusses the potential of UV-Vis spectroscopy in emerging areas such as personalized medicine and point-of-care diagnostics. As technology continues to evolve, UV-Visible spectroscopy is poised to significantly contribute to the ever-expanding landscape of pharmaceutical and bio-related research.

State market surveillance of non-food products in Ukraine: analysis of the decision of the Constitutional Court of Ukraine № 9-r(ii)/2023 dated November 1, 2023 in case № 3-53/2022(126/22)

The article analyzes the problem of state market supervision of non-food products in Ukraine. Problematic aspects of administrative and economic responsibility for putting into circulation products that do not meet the established requirements are considered. The decision of the Constitutional Court of Ukraine No 9-р(ii)/2023 of November 1, 2023 in case No 3-53/2022(126/22) and the separate opinion of the judge of the Constitutional Court of Ukraine G.V. Yurovskaya were analyzed on this issue. It is noted that strengthening consumer protection and improving quality control and safety of products and services are important tasks for any country, including Ukraine. And the creation of an effective legislative mechanism that guarantees consumer rights and determines the responsibility of enterprises for the quality and safety of products stimulates the development of entrepreneurship and competitiveness in the market, which in turn helps to improve the investment climate and ensures a balanced development of the economy. The process of improving legislation on the protection of consumer rights is considered. It has been proven that legislative changes in this area were aimed at reducing corruption risks in the field of monitoring compliance with requirements for the quality and safety of products and services, and the increase in fines for product distributors who did not provide the necessary documentation for supplier identification was aimed at creating economic conditions at which it will be unprofitable to trade products without proper documents. Attention has been drawn to the possibility of establishing absolutely defined and (or) non-alternative sanctions in acts of public legislation in the case when the subject of law enforcement is a government body other than a court. A balance between clarity of sanctions and flexibility in their application has been proven to help ensure fairness and efficiency of the legal system.