High Level Of Quality Control Research Articles

B-297 Tacrolimus Concentrations in Envarsus vs Prograf Patients: An Evaluation of the Clinical Impact of LC-MS/MS and Immunoassay Methods on Tacrolimus measurement

Abstract Background Tacrolimus is a calcineurin inhibitor used as part of an immunosuppressive regimen in kidney and liver transplant patients to prevent graft-versus-host disease (GvHD) and requires therapeutic drug monitoring due to its narrow therapeutic index. Tacrolimus levels are commonly measured using two different methodologies - immunoassay and liquid chromatography tandem mass spectrometry (LC-MS/MS). A global proficiency study to assess and compare the measurement of trough levels by these two methodologies noted a positive bias with the ARCHITECT immunoassay which is likely due to the presence of tacrolimus metabolites. The aim of our study is to assess the impact of two different formulations of tacrolimus on the accuracy of its analytical measurement. While differences between immunoassay and LC-MS/MS results have been evaluated for immediate-release tacrolimus (Prograf), it has yet to be characterized for extended-release formulations such as Envarsus. The discrepancy between immunoassay and LC-MS/MS has clinical implications, as dosage modifications are based on measured concentrations, analytical variation may cause intervals of subtherapeutic or supratherapeutic exposure, increasing the risk of graft rejection or toxicity. Methods Development of an LC-MS/MS method for the simultaneous quantification of tacrolimus and its major metabolite, desmethyl tacrolimus, was performed in whole blood. Traceable calibrators and quality control material for tacrolimus and specimens supplemented with desmethyl tacrolimus were used to determine accuracy and precision. Tacrolimus concentrations were measured by LC-MS/MS and ARCHITECT immunoassay methods in excess whole blood specimens from patients treated with either Prograf or Envarsus. Measurement biases between LC-MS/MS and immunoassay methodologies were determined for both formulations of tacrolimus. Results External calibration curves for both tacrolimus and desmethyl tacrolimus were linear (R2>0.995), and the analytical measurement range (AMR) for tacrolimus spanned from 1.1 - 31.6 ng/ml. Calibrator and Quality control (QC) biases were within 15% of their target values throughout the AMR and within-run imprecision was less than 10% (n=25) for all calibrators and QCs. Between-run imprecision for Low, Mid, and High QC levels over a period of 2 weeks (n=5 days) was less than 10%. Comparative bias of tacrolimus concentrations between immunoassay and LC-MS/MS was significantly lower (P value=0.0074) for Envarsus (n=20 specimens) relative to Prograf (n=32 specimens). Conclusions The differential bias between immunoassay and LC-MS/MS in the measurement of tacrolimus in patients dosed with immediate-release versus extended-release formulations suggests that their distinct pharmacokinetic profile may impact the accuracy of the measurement. Therefore, applying observed measurement biases from different assays derived from Prograf patients to Envarsus patients and vice versa may result in erroneous estimation of tacrolimus concentrations.

B-004 Method Validation of Lactate in the Plasma of Rats

Abstract Background The objective of this study is to validate Lactate (LAC) measurement in rat plasma using the ADVIA 1800 analyzer. Methods LAC was validated in rat plasma using the ADVIA 1800 analyzer. Validation testing included intra-assay and inter-assay precision, accuracy, linearity of dilution, limit of quantitation (LOQ), limit of detection (LOD), reference interval, carry-over, correlation, recovery, and stability. Samples were collected into tubes containing sodium fluoride. Intra-assay precision was determined by analyzing two biological samples and the two quality control levels of Bio-Rad Lyphochek Assayed Chemistry Control 10 consecutive times. Inter-assay precision was determined by analyzing the two quality control levels in duplicate for six days over a 10-day period. Accuracy was calculated using the data obtained from the inter-assay precision testing. For linearity of dilution, Audit MicroControl General Chemistry Linearity Kit and biological samples were diluted and analyzed in duplicate. The LOQ was determined by diluting the calibrator material to produce a value at the low end of the reportable range. Diluted material was tested six times. The LOD was determined by assaying the appropriate blank 10 times. The reference interval was determined by analyzing 21 plasma samples. Correlation between the two ADVIA 1800 analyzers was determined by assaying 10 samples on both analyzers once. The carry-over of the assay was determined by analyzing the high-level quality control material followed by the low-level quality control material. Recovery was determined by analyzing a pair of test samples in duplicate that have been spiked and diluted. The proportional error between the two test samples was calculated. Stability of plasma samples was tested on wet ice, refrigerated, and frozen (at -70°C) for various durations of storage. Results Measurement of LAC in rat plasma met the acceptance criteria for precision, accuracy, linearity of dilution, limit of quantitation, carry-over, recovery, and stability. For intra-assay precision in specimen and control material, the %CV was within ±20%. The inter-assay precision %CV was within ±20%. The total error observed (TEobs) was within ±20% for accuracy and the obtained mean of the control material was within the manufacturer’s acceptable range. For linearity of dilution, the coefficient of determination was ≥ 0.9000, the slope was within 1.00 ± 0.25, and TEobs for each plasma and linearity kit dilution was ≤20%. The LOQ was set at the lowest concentration for which the TEobs was within ±20%. The LOD was calculated by adding the mean concentration obtained and three times the standard deviation. The reference interval was set to the 2.5th to 97.5th percentile interval using Excel software. The carry-over was acceptable at ≤2%. Correlation between the two ADVIA 1800 analyzers was determined to describe any bias in result interpretation. Recovery was acceptable as the proportional error was within ±20%. Stability at all storage conditions was found to be acceptable with a mean %difference within ±20%. Conclusions LAC in rat plasma met the acceptance criteria for all required validation parameters. The ADVIA 1800 analyzer can be used for preclinical studies to test LAC in rat plasma.

Xanthan gum ink based on Lycium ruthenicum anthocyanin as an indicator of color change for monitoring freshness of cold fresh meat

The continuous development of intelligent food packaging has led to an increased focus on using freshness-indicating inks, which could provide a high level of quality control and consumer experience. This study aimed to further promote the application of xanthan gum ink in food freshness indication by optimizing its performance in screen printing. A novel freshness-indicating ink was prepared using Lycium ruthenicum anthocyanin (LRA) as the core indicator, glucose as the pigment carrier, soybean oil as the linker, and xanthan gum (XG) as the thickener. Scanning electron microscopy (SEM) demonstrated that the ink was uniformly distributed on paper using screen printing. Rheological and particle size analyses revealed that the incorporation of XG significantly enhanced the interaction force between droplets in the ink system. Further tests on viscosity, fineness, and initial dryness indicated that XG, a natural microbial polysaccharide with excellent stability, could effectively improve the flowability of the ink. Specifically, at a 0.3 % XG content, the ink exhibited a unimodal particle size distribution with an average particle size of 851.02 nm and a zeta potential of −27 mV. This indicated the ink system was stable and uniform, with optimal rheological properties and printing suitability. Furthermore, the printed freshness indication labels exhibited a significant change in color as the freshness of the refrigerated meat changed. This study develops a natural and safe method for monitoring the freshness of refrigerated meat and provides an optimized idea for applying indicator inks.

Quantification of asciminib by LC-MS/MS method in human plasma: Validation and stability studies

An accurate, sensitive, and linear liquid chromatographic tandem mass spectrometric method was developed for the quantification of asciminib in human plasma. Voriconazole, internal standard (IS), and asciminib were isolated from the plasma samples by C18-cartridges. Chromatographic isolation was processed with Atlantis/dC18 (2.1 × 100 mm, 3 μm) stationary phase and a mobile solvent system of formic acid (0.1%) and methyl alcohol (20:80, v:v), conveyed at a 0.7 ml/minute flowing rate. Analytes were quantified by ionization in a positive approach with electrospray ionization at the mass transitions of (m/z): asciminib, 450.11/239.09, and voriconazole (IS), 350.3/281.1. No interference by constituents of plasma blank or other components was detected. The association between asciminib concentration levels and their respective peak response fractions to voriconazole was rectilinear between 39.0 and 1,586.0 ng/ml. Intraday and interday precisions were ≤4.79% for asciminib. The interday bias was between −4.28% and 5.76%, and the intraday bias was −3.75% and 4.53%. The mean measured extraction recovery of asciminib was 99.06%. The recovery of IS was 98.34%. Asciminib was subjected to long-term, bench-top, freeze-thaw, short-term stability, dry extract, auto-sampling, and stock solution stability at Low quality control and High quality control levels, and it was stable at all these conditions. The established technique can be utilized for the regular quantification of asciminib in plasma samples in industries, forensic laboratories, and clinical research organizations.

A high-throughput LC-MS/MS assay for piperaquine from dried blood spots: Improving malaria treatment in resource-limited settings

BackgroundMalaria is a parasitic disease that affects many of the poorest economies, resulting in approximately 241 million clinical episodes and 627,000 deaths annually. Piperaquine, when administered with dihydroartemisinin, is an effective drug against the disease. Drug concentration measurements taken on day 7 after treatment initiation have been shown to be a good predictor of therapeutic success with piperaquine. A simple capillary blood collection technique, where blood is dried onto filter paper, is especially suitable for drug studies in remote areas or resource-limited settings or when taking samples from children, toddlers, and infants. MethodsThree 3.2 mm discs were punched out from a dried blood spot (DBS) and then extracted in a 96-well plate using solid phase extraction on a fully automated liquid handling system. The analysis was performed using LC-MS/MS with a calibration range of 3 – 1000 ng/mL. ResultsThe recovery rate was approximately 54–72 %, and the relative standard deviation was below 9 % for low, middle and high quality control levels. The LC-MS/MS quantification limit of 3 ng/mL is sensitive enough to detect piperaquine for up to 4–8 weeks after drug administration, which is crucial when evaluating recrudescence and drug resistance development. While different hematocrit levels can affect DBS drug measurements, the effect was minimal for piperaquine. ConclusionA sensitive LC-MS/MS method, in combination with fully automated extraction in a 96-well plate format, was developed and validated for the quantification of piperaquine in DBS. The assay was implemented in a bioanalytical laboratory for processing large-scale clinical trial samples.

The position of the Queen Elisabeth Rehabilitation hospital (KEI) in the chain of Integrated Care

Introduction: Governments put health-system strengthening as priority. They particularly strive for person-centred health-systems. Integrated Care is seen as the way forward to achieve this. To improve patient experience and health outcomes, healthcare should be organised ‘horizontally’ around the patient and should be ‘vertically’ integrating services in various levels and settings. The Queen Elisabeth Rehabilitation hospital (KEI), encompassing 165 beds, wants to play a role in better healthcare for patients with specific and complex rehabilitation needs (cardiopulmonary, locomotor and neurological) and strives to centre its services on the needs of the patients, their families and the broader community.
 Methods and aim: In order to formulate a well-articulated strategic plan, KEI critically scrutinised its current work by studying available data. Since KEI developed a high level quality control management-plan, data from 2021 could be extracted from the patients records and analysed.
 Results: KEI, driven by a holistic vision on rehabilitation (medical, functional, social and psychological) intensively puts efforts in interdisciplinary team-integration (specialist-physicians, dietitians, occupational, speech- and language-, physiotherapists, psychologists, nurses, assistant nurses) supported by electronical patient-records and grounded in patient-participation. Also preventive (mostly ambulatory) coaching is offered (e.g. smoking cessation, tackling malnutrition and obesity). Patients admitted to KEI in 2021 (n= 1215) were transferred from hospitals (9% university-hospitals/83% non-university), from home (7%) and from nursing-homes (1%). They are discharged towards home (74%), nursing-homes (11%) or back to a hospital (11%). After discharge, extensive ambulatory follow-up was conducted with 2178 ambulatory consultations. This means that KEI extensively collaborated and exchanged information with stakeholders in the region: regional hospitals, primary care, nursing-homes. To fulfil its supra-regional task, KEI collaborates also with university-hospitals throughout Flanders. Several official agreements and care pathways are in place to organise al this collaboration. 
 Discussion and conclusion: Aiming to improve patients/informal caregivers’ experiences, KEI developed pre- and post-trajectories, which is only possible through well-integrated care and good cooperation with other facilities, e.g. acute hospitals, care for the older persons (nursing-homes, assisted-living facilities) and primary care. KEI has expanded this diversity within the own facilities, but also with other partners. In this way, KEI is today playing a local as well as a supra-regional role, but strives to upgrade his part as legitimate, recognized, complementary and responsible partner in transversal collaboration towards integrated between micro-, meso-and macro-level. Although Integrated Care is an explicit task the Flemish government directed towards rehabilitation-hospitals, it is hard to really integrate care around the needs of patients and informal caregivers, mainly because of insufficient ‘vertical integration’ since services are not organized under one management umbrella. The locoregional acute hospital networks in development might be a step forward since they allow the formation of alliances and arrangements on a local level, though rehabilitation-hospitals are not part of it. Several challenges still lie ahead such as the search for a common reason of being, i.e. understanding the needs from a population health goals; common mission and strategy; joint funding and planning with shared outcomes. Also strong leadership with trust in each other and clear governance arrangements are needed.

Integration of The Lean Six Sigma Model in The Distribution of Goods to Minimize Delivery Delays at PT. AMA

PT. AMA is a company operating in the goods distribution industry (cement-non-cement). A problem that is the focus of research at PT. AMA is a delay in delivery by the company's fleet. In this research, the method used is the integration of the Lean Six Sigma model which combines the philosophy of waste reduction from Lean and the high-level quality control approach from Six Sigma where with the help of research using Visual Stream Mapping to visualize the company's operational processes to identify in more depth the root of the problems that cause there is a delay in the delivery of goods. Which results in a total lead time of 770 minutes and value-added time of 420 minutes with an error rate of 22% and a Six Sigma value of 2.29. Proposed improvements to the new goods distribution operational system using the 5W-1H method analysis. The results of the research that has been carried out show that the integration of the Lean Six Sigma model significantly reduces waste, optimizes a distribution process and increases on-time delivery.

Deep eutectic solvent-based ferrofluid for vortex-assisted liquid-liquid microextraction of nonsteroidal anti-inflammatory drugs from environmental waters

A novel ferrofluid of Fe3O4 nanoparticles and a deep eutectic solvent (DES) composed of menthol and pentanoic acid was introduced as a green microextraction medium. The ferrofluid was successfully used as an extractant for vortex-assisted liquid-liquid microextraction (VALLME) of nonsteroidal anti-inflammatory drugs (NSAIDs) in environmental waters prior to their determination by HPLC-DAD. Once the ferrofluid was dispersed in the sample by vortex agitation, phase separation could be easily achieved by placing a neodymium magnet next to the tube, which eliminated the centrifugation step and simplified the operational procedure. As a result, the sample pretreatment took only ≈2 min. The experimental parameters, including pH, nanoparticle amount, ferrofluid volume, vortex time, salt amount, and disruptive solvent type and its volume, were optimized stepwise. The method showed linear behavior for all NSAIDs from 5 to 100 μg/L, with limit of detection values and enrichment factors in the ranges of 1.68–2.05 μg/L and 38.9–50.6, respectively. Intra- and Inter-day accuracies obtained from the analysis of spiked river, lake, and tap water samples at low and high-quality control levels (20 and 80 μg/L) ranged from 90.3% to 108.0%, with relative standard deviations less than <12.3%. The results of this study demonstrate that the use of DES-based ferrofluid in VALLME can be considered a simple, environmentally friendly, and reliable alternative for the determination of NSAIDs in environmental waters.

B-002 Method Validation of Cystatin-C in the Serum of Dogs

Abstract Objective The objective of this study is to validate the new Siemens Cystatin-C reagent for analysis of dog serum on the ADVIA 1800 analyzers. Methodology The ADVIA 1800 analyzer was used in the validation of Cystatin-C in Dog serum. Whole blood samples were collected in tubes free of anti-coagulant and centrifuged for 10 min at 2400 rpm. Serum was separated after centrifugation using appropriate separation techniques. Testing disciplines for the validation included intra-assay precision, inter-assay precision, accuracy, linearity, limit of quantitation (LOQ), limit of detection (LOD), reference interval, carryover, correlation, and stability. Intra-assay was determined by analyzing two biological samples and the three quality control levels of BioRad Liquichek Immunology Control 10 consecutive times (in duplicate) within a single run. Analysis of two biological samples and three levels of BioRad Liquichek Immunology Control six times for six days over a 10-day period was conducted to determine inter-assay precision. Accuracy was calculated using the data from the inter-assay precision testing. Specimen samples and Siemens Cystatin C-2 Calibrator were diluted and analyzed in duplicate for linearity. To determine LOQ calibrator was diluted to produce a value at the low end of the reportable range and tested six times within the same run. LOD was determined by assaying the appropriate blank 10 times within the same run. The reference interval was determined by analyzing 21 serum samples. Through analyzing 10 serum samples on both ADVIA 1800 analyzers correlation between analyzers could be determined. The carry-over of the assay was determined by analyzing the high-level quality control material followed by the low-level quality control material three consecutive times. Stability of serum samples was tested at room temperature, refrigerated, and frozen (at −20°C) for various durations of storage. Results The measurement of Cystatin-C in Dog serum met the acceptance criteria for intra-assay precision, inter-assay precision, accuracy, linearity of dilution, LOD, LOQ, carry-over, and stability as articulated in the results. The intra-assay precision and inter-assay precision in specimen and control material %CV was within ±20%. For accuracy the total error observed (TEobs) was within ±20% and the mean was within the acceptable range specified by the manufacturer. For linearity of dilution, the coefficient of determination was ≥0.9000 and TEobs for each dilution was lower than ±20%. The LOD was calculated by adding the mean concentration and 3 times the standard deviation. LOQ was set at the lowest concentration measured at which the %CV, %bias, and TEobs was within ±20%. The reference interval was set to the 2.5th to 97.5th percentile interval. The carry-over was accepted as it was ≤2%. Correlation between the two ADVIA 1800 analyzers was determined to describe any bias in result interpretation. Stability was found to be acceptable at all storage conditions with a mean difference within ±20%, except freeze/thaw #2. Conclusion Cystatin-C in Dog serum met the acceptance criteria for all required validation parameters. The ADVIA 1800 analyzer can be used for preclinical studies to test Cystatin-C in dog serum.

B-001 Method Development of C-Reactive Protein in the Serum of Non-Human Primates

Abstract Objective The objective of this study is to validate C-Reactive Protein (CRP) measurement in Non-Human Primate (NHP) serum using the ADVIA 1800 analyzer. Methods CRP was validated in NHP serum using the ADVIA 1800 analyzer. Validation testing included intra-assay precision, inter-assay precision, accuracy, linearity of dilution, limit of quantitation (LOQ), limit of detection (LOD), reference interval, carry-over, correlation, and stability. Samples were collected into tubes containing no anti-coagulant. Intra-assay precision was determined by analyzing two biological samples and the two quality control levels of Bio-Rad Lyphochek Immunology Plus Control 10 consecutive times (in duplicate) within a single run. Inter-assay precision was determined by analyzing two biological samples and the two quality control levels of Bio-Rad Lyphochek Immunology Plus Control six times for six days over a 10-day period. Accuracy was calculated using the data obtained from the inter-assay precision testing. For linearity of dilution, calibrator material and diluted specimen samples were analyzed in duplicate. The LOQ was determined by diluting the low-level calibrator material to produce a value at the low end of the reportable range. Diluted material was tested six times within the same run. The LOD was determined by assaying the appropriate blank 10 times within the same run. The reference interval was determined by analyzing 21 serum samples. Correlation between the two ADVIA 1800 analyzers was determined by assaying 10 samples on both analyzers once. The carry-over of the assay was determined by analyzing the high-level quality control material followed by the low-level quality control material. Stability of serum samples was tested at room temperature, refrigerated, and frozen (at -20°C) for various durations of storage. Results Results show that measurement of CRP in NHP serum met the acceptance criteria for intra-assay precision, inter-assay precision, accuracy, linearity of dilution, limit of quantitation, carry-over, and stability. For intra-assay precision in specimen and control material, the %CV was within ±20%. The inter-assay precision for specimen and control material %CV was within ±20%. The total error observed (TEobs) was within ±20% for accuracy in control material and the obtained mean was within the acceptable range specified by the manufacturer. For linearity of dilution, the coefficient of determination was ≥0.9000 and TEobs for each dilution and calibrator level was lower than 20%. The LOQ was set at the lowest concentration for which the TEobs was within ±20%. The LOD was calculated by adding the mean concentration obtained and three times the standard deviation. The reference interval was set to the 2.5th to 97.5th percentile interval using Excel software. The carry-over was acceptable as it was ≤2%. Correlation between the two ADVIA 1800 analyzers was determined to describe any bias in result interpretation. Stability at all storage conditions was found to be acceptable with a mean %difference within ±20%. Conclusion CRP in NHP serum met the acceptance criteria for all required validation parameters. The ADVIA 1800 analyzer can be used for preclinical studies to test CRP in NHP serum.

Research progress in quality control of Bufonis Venenum in preparations

Bufonis Venenum, an animal medicinal material, is widely used for treating cardiovascular diseases and pain induced by rheumatics or malignant tumors. In view of the high activity and high toxicity, it is of great significance to pay attention to the quality control of Bufonis Venenum to ensure the safety and effectiveness of its preparations. China's drug standards involve 102 preparations(474 batch numbers) containing Bufonis Venenum approved for sale, including 14 preparations in the Chinese Pharmacopoeia(2020 edition) and 68 preparations in the standards issued by the Ministry of Health Drug Standard of the People's Republic of China. Bufonis Venenum is mostly used in pill and powder preparations in the form of raw powder, with the main functions of clearing heat, removing toxin, relieving swelling and pain, replenishing qi, activating blood, opening orifice, and awakening brain. Except the high level of quality control for Bufonis Venenum in the preparations in the Chinese Pharmacopoeia(2020 edition), the quality control standards of Bufonis Venenum in other preparations are low or even absent. Therefore, it is urgent to conduct research on the improvement of quality standards for the preparations containing Bufonis Venenum. This study retrieved the reports focusing on the quality evaluation and quality control of the preparations containing Bufonis Venenum from CNKI, PubMed, and Web of Science. Qualitative and quantitative analysis methods for 64 preparations containing Bufonis Venenum have been reported, mainly including thin-layer chromatography, HPLC fingerprint, and multi-component content determination. The index components mainly involved bufadienolides, such as gamabufalin, arenobufagin, bufotalin, bufalin, cinobufagin, and resibufogenin. According to the literature information, this paper suggests that attention should be paid to the correlations between the analysis methods and detection indexes of medicinal materials, decoction pieces and preparations, the monitoring of indole alkaloids, and the content uniformity inspection for further improving the quality standards for the preparations containing Bufonis Venenum.

Simultaneous determination of eight antiepileptic drugs and two metabolites in human plasma by liquid chromatography/tandem mass spectrometry

AbstractEpilepsy is one of the most prevalent neurological conditions and antiepileptic drugs are the mainstay of epilepsy treatment. High variation in pharmacokinetic profiles of several antiepileptic drugs highlights the importance of therapeutic drug monitoring to estimate pharmacokinetic properties and consequently individualize drug posology. In this work, a simple, rapid and robust liquid chromatography-tandem mass spectrometry method was developed for simultaneous quantification of carbamazepine and its metabolite carbamazepine-10,11-epoxide, gabapentin, levetiracetam, lamotrigine, oxcarbazepine and its metabolite mono-hydroxy-derivative metabolite, phenytoin, topiramate, and valproic acid in human plasma for therapeutic drug monitoring. d6-Levetiracetam, d4-gabapentin and d6-valproic acid were used as internal standards. After addition of internal standards along with two-step protein precipitation and dilution sample preparation, plasma samples were analyzed on a C18 column using a gradient elution in 5 min without interference. The calibration curves were linear over a 100-fold concentration range, with determination coefficients (r2) greater than 0.99 for all analytes. The limit of quantification was 0.5 μg mL−1 (0.1 μg mL−1 for oxcarbazepine, 2 μg mL−1 for levetiracetam, and 10 μg mL−1 for valproic acid) with precision and accuracy ranging from 3% to 9% and from 94% to 112%, respectively. Intra- and inter-day precision and accuracy values were within 15% at low, medium and high quality control levels. No significant matrix effect was observed in the normal, hemolyzed, lipemic, and hyperbilirubin blood samples. This method was successfully used in the identification and quantitation of antiepileptic drugs in patients undergoing mono- or polytherapy for epilepsy.

КРАФТОВЕ ВИРОБНИЦТВО ЯК ДЖЕРЕЛО РОЗВИТКУ ТУРИСТИЧНОЇ ГАЛУЗІ РЕГІОНУ

Due to pandemic and full-scale war in Ukraine the work of shops, shopping centers, catering companies is restricted; also many enterprises are closed, unemployment rate is too high. This situation results in decreasing the quality of recreation and stopping tourist travelling. However, tourist industry enables people to receive positive impressions, broaden outlook, learn new culture and history. Moreover, it fosters the income of population, region and country to grow. The development of craft business can help to reach the pre-war and pre-quarantine returns from the tourist business. That is why the study of peculiarities, features and activities of craft production is relevant. The purpose of research is to analyze the range of goods in craft production available in the south of Ukraine. The research is aimed for defining impact of above-mentioned goods on the advancement of other spheres of economic activity. From SWOT-based analysis of craft business the fact arises that the demand on natural and unique products is increasing with the competition between craft producers. It should be stressed that there are some legislative restrictions; and certification approving the product quality is needed. Craft production is characterized by flexibility, usage of high-quality raw materials, original recipe, high level of quality control, fast response on changes in consumers’ demand, possible business relocation. But there exist some problems: manual labor, lack of technological processes automation, prevailed creative process over commercial one. The most developed trends of craft production in the south of Ukraine are bread and bakery, confectionery, alcohol drinks, dairy, meet, vegetable products and cheese. The region has a potential to provide the raw materials base for the production of these goods. The production of craft goods positively affects the development of gastronomic tourism. In craft brewery one can try tasteful beer and authentic Ukrainian cuisine. Visiting wineries and historical places, small museums, for example, museums of old agricultural implements, machines, rural kitchen utensils will promote the advance of eno- and ethnotourism. It is common knowledge that wine is served with sweets, cheese, sausages, bakery. This will encourage craft producers to gain profits and attract new tourists to the region. Production of craft goods is the key to the development of other economic spheres.

A Case Study of Human Milk Banking with Focus on the Role of IoT Sensor Technology

Human milk is the biological norm for newborn nutrition, with breast milk from the mother being recognized as the best source of nutrition for infant health. When the mother’s milk is unavailable, donor human milk is the best alternative for infants with low birthweights. Growing recognition of the benefits of donor human milk has led to increasing global interest in monitoring and controlling human milk’s quality to fulfil the need for donor human milk. In response to this need, the REAMIT project proposed to adapt and apply existing innovative technology to continuously monitor and record human milk quality and signal potential milk quality issues. IoT sensors and big data technology have been used to monitor conditions that may increase spoilage (such as temperature and humidity) in the transportation stage. The sensors were installed in the insulated bags used to transport the milk from the donor’s home or hospital to the human milk bank and vice versa. The temperature and humidity were collected every 30 min, whilst the GPS locator sent data every 2 min. The data are collected in the cloud using GPRS/CAT-M1 technology. An algorithm was designed to send alerts when the milk temperature is above the prespecified threshold specified by the organisation, i.e., above −20 °C. The experience showed evidence that IoT sensors can efficiently be used to monitor and maintain quality in supply chains of high-quality human milk. This rare product needs a high level of quality control, which is possible with the support of smart technologies. The IoT technology used can help the human milk supply chain in five different aspects, namely by reducing waste, assuring quality, improving availability, reducing cost and improving sustainability. This system could be extended to various supply chains of rare and precious commodities, including further medical supplies such as human blood and organs, to completely avoid waste and ensure total quality in supply chains.

LC–MS/MS Method for Determination of Non-opioid Analgesics Adulterants in Herbal Medicines

The increased use of herbal medicines necessitates their quality and safety assurance. Among of other factors affecting herbal medicines is adulteration with conventional drugs that can potentially contribute to human health effects. This stimulate the high level of quality control that can be done by having strengthened analytical capacity. The present study developed a high throughput method for the determination of five (5) non-opioid analgesics namely acetaminophen, caffeine, acetylsalicylic acid, ibuprofen and diclofenac. A developed method was validated for its selectivity, sensitivity, linearity, accuracy, precision, recovery, matrix effects and stability. The results showed a good linear relationship with the concentration of the analytes over wide concentration ranges (0.001–10.00 µg/mL) with a coefficient of determination, R2 ≥ 0.9931. The limit of detection (LOD) and limit of quantification (LOQ) for each compound were within the range of 0–3.7 µg/mL. The intra-precision of the method was expressed as relative standard deviation and was less than 9.5% with varying matrix effect from 68.56 to 138.88%. The absolute recoveries ranged from 59.63 to 107.10%. Among 132 collected samples, 21% were adulterated with caffeine and acetylsalicylic acid. The method developed met the ICH guidelines for detection and quantification of acetaminophen, caffeine, acetylsalicylic acid, diclofenac and ibuprofen in HM. Elimination of adulteration by introducing measures like setting education programmes for practitioners are recommended.

The challenges confronting the growth of sustainable prefabricated building construction in Australia: Construction industry views

The construction industry has played a huge role in sustaining the economy of Australia during the ongoing Covid-19 pandemic. However, construction activities tend to be limited due to the restrictions on travel, transport, and workforce availability which in turn affects the lack of materials and workforce for construction. On the other hand, the prefabricated construction method is known to provide a sustainable solution to reduce the labour and material demand. However, prefabricated construction methods are less preferred over traditional construction in Australia. This is due to the lack of knowledge on the benefits, limitation, design and construction of the prefabricated construction. Therefore, in this study, the authors have conducted a survey to identify the construction industry views on the prefabricated construction in terms of sustainability, technical, cultural, economic, practical and other aspects. A total of 310 construction professionals responded, and the data were analysed using both qualitative (thematic) and quantitative (Severity index) analyses. Results revealed that reduced construction time, high levels of quality control, and reduced on-site noise and disruption were the major benefits when using prefabricated construction compared to traditional construction. The restrictions and limitations of transport; reduced on-site design flexibility; and shortage of specialised workforce hindered the growth of prefabricated construction. These survey results also highlighted that production and manufacturing of prefabricated construction are not affected significantly by the Covid-19 pandemic. Furthermore, significant amount of traditional, residential and commercial construction projects were replaced by prefabricated construction during Covid-19 pandemic, suggesting a future growth in prefabricated construction in Australia.

Comparison of Domestic and International Technical Standards: Study on Improvement of Quality Control of Halogenated Fire Extinguishing Agents

Recently, the National Fire Protection Association (NFPA) announced the revised standards for halogen compound fire extinguishing facilities (NFPA 2001). Characteristically, it is strengthening the quality control standards for halogenated fire extinguishing agents, by presenting specific standards regarding the effects of not only their main ingredient, but also their additional ingredients on the human body. However, in Korea, halogen compound fire extinguishing agents used for firefighting purposes are managed by designating “purity” as the sole criteria for inspection. Considering that halogen compounds utilized for other purposes in Korea are undergoing quality control through various inspections for the safety of humans and the environment, it is evident that a higher level of quality control is required for halogen compounds used for firefighting purposes. Therefore, we would like to suggest a specific improvement plan to enhance safety while using halogenated fire extinguishing agents, through the comparative analysis of inspection criteria, and acceptance standards of corresponding domestic and foreign standards.

A Curriculum Model for Multidisciplinary Training of Midwife Sonographers in a Low Resource Setting.

In many low-resource settings, less than 5% of pregnant women can access ultrasound during pregnancy. Thus, gestational age is often difficult to determine, multiple pregnancies are diagnosed late and foetal and pregnancy-related anomalies can go undetected. A pilot solution was designed beyond the traditional approach of increasing numbers of qualified radiologists, gynaecologists and sonographers. An innovative Human Resource for Health (HRH) task sharing, and maternal child health (MCH) workforce training and capacity building initiative was designed, involving development and testing of a curriculum to train midwife sonographers via a teleradiology innovation platform and a partnership between specialist radiologists, sonographers and midwives. The setting was a tertiary-level private university hospital in Nairobi with implementation in three outreach locations. Direct oversight, support and supervision of specialist radiologists and ultrasonographers effectively addressed issues of quality and safety across the 3-week training period and project implementation. Concepts from sociocultural learning theory informed an initial interactive e-learning module for each midwife at their respective site. Midwives were introduced to ultrasound equipment with a series of didactic and interactive lectures delivered by an expert sonographer at the tertiary hospital teaching site. Lectures were supported by hands-on practical experience, role modelling and mentoring over a four-week period. Assessments included both written examination and practical assessment with an exit examination requiring demonstration of competency in both written and practical format. Final confirmation of scanning accuracy was confirmed with post-delivery verification of results. The pilot was highly successful with an image interpretation accuracy of 99.63% for the midwives. Lessons from this initiative provides guidance in the curriculum development process along with a curriculum outline; pedagogical framework; teaching methods; assessment processes; credentialing; resourcing; and other considerations in scaling up the program. Importantly, the paper details processes for maintaining a high level of quality control and patient safety.

The Potential of Iodine and Iron Double-Fortified Salt Compared with Iron-Fortified Staple Foods to Increase Population Iron Status

The potential of double-fortified salt (DFS) to improve population iron status is compared with the potential of iron-fortified wheat flour, maize flour, rice grains, and milk products. The potential for a positive impact on iron status is based on reported efficacy studies, consumption patterns, the extent of industrialization, and whether there are remaining technical issues with the fortification technologies. Efficacy studies with DFS, and with iron-fortified wheat flour, maize flour, and rice, have all reported good potential to improve population iron status. Iron-fortified milk powder has shown good impact in young children. When these foods are industrially fortified in modern, automated facilities, with high-level quality control and assurance practices, high-quality raw materials, and a wide population coverage, all vehicles have good potential to improve iron status. Relative to other fortification vehicles, fortification practices with wheat flour are the most advanced and iron-fortified wheat flour has the highest potential for impact in the short- to medium-term in countries where wheat flour is consumed as a staple. Liquid milk has the least potential, mainly because an acceptable iron fortification technology has not yet been developed. Maize is still predominantly milled in small-scale local mills and, although the extruded rice premix technology holds great promise, it is still under development. Salt has a proven record as an excellent vehicle for iodine fortification and has demonstrated good potential for iron fortification. However, technical issues remain with DFS and further studies are needed to better understand and avoid color formation and iron-catalyzed iodine losses in both high- and low-quality salts under different storage conditions. There is currently a risk that the introduction of DFS may jeopardize the success of existing salt iodization programs because the addition of iron may increase iodine losses and cause unacceptable color formation.

A sort of validated Bioanalytical method developed for the estimation of Etoposide and Cisplatin in rat plasma by using two different advanced liquid chromatographic techniques like HPLC and UPLC and its application in bioequivalence studies

An easy, quick, precise, active and reproducible reverse method high performance liquid chromatography (RP-HPLC), as well as Ultra pressure liquid chromatography (UPLC) unique technique, was developed for the bioanalytical method of Etoposide and Cisplatin with Oxaplatin as an internal standard. Chromatographic analysis was performed using HPLC was Waters Alliance e-2695, and UPLC was Waters Acquity UPLC by using x-bridge phenyl 150x4.6mm, 3.5µ column and therefore the mobile phase containing 0.1% triethylamine and acetonitrile at a ratio out of 60:40 v/v. The flow rate was 1 ml/min, and analytes were detected at 283 nm employing a photodiode array detector at ambient temperature in both liquid chromatographic systems. The proposed biological method was proved in both HPLC and UPLC with USFDA guidelines. USP tailing is 1.1, 1.02 for etoposide and 1.16, 1.05 for Cisplatin in HPLC and UPLC. USP plate count is 4794, 3884 for Etoposide and 9289, 14487 for Cisplatin. The calibration curve under accumulation set of 5-100 ng/ml of etoposide and 10-200 ng/ml of Cisplatin in both HPLC and UPLC. The accuracy of low, middle and high-level quality control samples are taken in 50%, 100% and 150% levels. Stability study was administered altogether conditions are bench top, wet extract and auto sampler, freeze-thaw, short term stability and in long term stability. This is the advanced technique established to the straightforward, economical, suitable, precise, accurate and stable method for the analysis of Etoposide and Cisplatin and study of its stability and pharmacokinetic studies using rat plasma.