Quality Control Of Preparations Research Articles

B-023 Workflow evaluation of the new Siemens Atellica CI Analyzer

Abstract Background The Atellica® CI Analyzer, Model 1900 is an integrated clinical chemistry and immunoassay analyzer that has the same user interface, general workflow, and planned test menu to that of the larger Atellica® Solution. Atellica CI Analyzer also shares the same reagents and consumables as the Atellica Solution. The purpose of this study was to evaluate workflow performance of the Atellica CI Analyzer in a routine-like clinical laboratory setting. Methods The study was conducted at four international laboratory facilities over a four-month period. Basic throughput of the Atellica CI Analyzer was evaluated at each site by testing quality control (QC) and remnant anonymized patient samples using an 8:2 mixture of chemistry (ion selective electrolytes [IMT], clinical chemistry analytes) and immunochemistry assays. Additionally, the impact of interrupting routine testing for STAT high-sensitivity cardiac troponin samples was also evaluated. Daily, weekly, and monthly maintenance activities were observed, and data collected through direct observations, time and motion studies, and system run logs. Results The Atellica CI Analyzer aspirated patient samples in as little as two minutes (mins) with the time to first result for the mixed assay worklist ranging from 1 to 12 mins from the time of first barcode read. Across the four sites, the time to last result for the mixed assay worklist (average n=495 test results per site) ranged from 52 to 65 mins. The average turn around time (TAT) for high-sensitivity troponin was 9 mins from barcode read. Daily maintenance and QC activities for the Atellica CI Analyzer are comprised of both automated and manual activities. The average daily maintenance hands-on time was 3.6 min, ranging from 1.6 to 6.4 mins across the four sites. Daily QC preparation required <5 mins of hands-on time. The total average hands-on time to complete weekly maintenance for the Atellica CI Analyzer was 7.5 min. Conclusions The Atellica CI Analyzer demonstrated consistent system performance across all four study sites. Implementation of the Atellica CI Analyzer has the potential to increase laboratory efficiency given the minimal hands-on time required for daily and weekly maintenance activities and short TATs.

Characterization of Structure-Surface Correlations in Ointments Using Surface Tensiometry within the Concept of an Integrated Analytical Approach.

In recent years, integrated data analysis has proven to be a valuable method for investigating complex systems, whether artificial or natural. The integrated analytical approach allows the simultaneous integration of data acquired from different analytical techniques employed for the same sample at the same time, leading to an expansion of the amount of information available. Surface tensiometry is a technique that was recently introduced in the Integrated Analytical Approach for investigating pharmaceutical dosage forms for topical application. Therefore, studies of rheological characterization, release, and skin permeation can be integrated with surface tensiometry measurements to develop chemical and rheological-surface correlation models, providing a new method for the quality control and process control of semisolid preparations. In this context, the aim of this research is to validate the utility of surface tensiometry measurements in the Integrated Analytical Approach and utilize these data to gain insights into the structure-surface correlation. The preparations chosen for this study were a PEG-gel, a lipogel, and an O/W cream containing carnitine as a model drug. The formulations were characterized using rheological measurements and evaluated for their carnitine release performance. Furthermore, surface tensiometry measurements were performed to rapidly and noninvasively assess the influence of carnitine on the surface properties of the semisolid preparations investigated. Our work demonstrated a close correlation between surface energy and structural data, showing the importance of surface tensiometry contribution in the noninvasive and rapid evaluation of the presence of carnitine in semisolid formulations.

Systematic Review of Platelet-Rich Plasma in Medical and Surgical Specialties: Quality, Evaluation, Evidence, and Enforcement.

Background: Platelet-rich plasma (PRP) is widely used in various medical and surgical specialties for its regenerative properties, including aesthetics (facial rejuvenation, hair restoration, and skin tightening) and orthopedics (treatment of tendinitis and osteoarthritis). However, the inconsistent literature on PRP's efficacy and safety leads to critical knowledge gaps. This systematic review evaluates quality control measures in PRP preparation and application and explores the regulatory environment governing its clinical use. Methods: Following PRISMA guidelines, a comprehensive search was conducted across multiple databases, including PubMed, EMBASE, and Web of Science, for studies published from January 2020 to April 2024. The review included randomized controlled trials (RCTs) involving human participants undergoing PRP treatment for aesthetic or regenerative purposes. Key parameters such as the PRP preparation methods, platelet concentration, and quality control measures were analyzed. The study protocol was registered with PROSPERO (ID: CRD42024557669). Results: Out of 75 RCTs involving 5726 patients, the review identified significant variability in PRP preparation methods and application techniques, including differences in centrifugation protocols and platelet concentration levels. A new evidence-based scoring system, the William-Eqram Scoring System for PRP Quality Reporting (WESS-PQR), was proposed to address these inconsistencies. Correlation analysis revealed a strong positive correlation (r = 0.79) between proper temperature control during preparation and PRP efficacy. Initial platelet count assessment showed a moderate positive correlation (r = 0.57) with efficacy. Conclusions: Standardized PRP preparation protocols and robust regulatory frameworks are urgently needed to ensure the safety and efficacy of PRP treatments. The proposed WESS-PQR scoring system can serve as a valuable tool for clinicians and researchers, promoting consistency and reliability in PRP applications.

Integrating deep learning and near-infrared spectroscopy for quality control of traditional Chinese medicine extracts

Extraction is a key fundamental step in producing most traditional Chinese medicine (TCM) products. Influenced by factors such as herbs and production techniques, the quality of TCM extracts may vary significantly, leading to high variability between batches and unstable quality of the products. Currently, high-performance liquid chromatography (HPLC) and other analytical methods have been employed for the quality control of TCM extracts, but these methods are time-consuming, environmentally unfriendly, and complicated in sample pre-treatment, which cannot meet the needs of actual production. Therefore, a rapid and effective method for the quality analysis and control of TCM extracts is urgently needed. In this study, the traditional Chinese medicine Radix Gentianae Macrophyllae (RGM) was taken as the research object, and a quantitative analysis model for the active ingredients loganic acid (LA) and gentiopicroside (GPS) was constructed based on near-infrared (NIR) spectroscopy, combining with convolutional neural network (CNN) and gated recurrent unit (GRU). Moreover, the multi-task mean square error (MTMSE) loss function proposed in this paper was used to train the model to ensure the prediction accuracy for different tasks. Meanwhile, this model integrated Bayesian optimization to automatically find the optimal hyperparameters without manual involvement. The results showed that the CNN-GRU model had higher prediction accuracy compared with CNN, BP, and PLS models. In addition, the feasibility of the CNN-GRU model was comprehensively analyzed. Finally, the feature extraction process of the CNN-GRU model was visualized to enhance the interpretability. This research creatively integrated deep learning with near-infrared spectroscopy to achieve rapid and accurate analysis of the active ingredient content of TCM extracts, providing new ideas and methods for quality control of TCM preparations.

Identification of chemical components in Qinggu San reference sample of classial prescription based on UHPLC-Q/Orbitrap HRMS combined with molecular network technology

The method of ultra-high performance liquid chromatography-quadrupole-electrostatic field orbitrap high-resolution mass spectrometry(UHPLC-Q/Orbitrap HRMS)combined with molecular network was developed in this study for rapidly analyzing the chemical components of the Qinggu San reference sample of classical prescription. Firstly, an ACQUITY UPLC BEH Shield RP_(18) column(2.1 mm×100 mm, 1.7 μm)was used, and acetonitrile and 0.1% formic acid were taken as the mobile phases for gradient elution. The flow rate was 0.4 mL·min~(-1), and the column temperature was 30 ℃. Under these conditions, the mass spectrum data were collected in both positive and negative ion modes of the heated electrospray ionization source. Subsequently, the mass spectrum data of the Qinggu San reference sample were uploaded to the Global Natural Products Social Molecular Network(GNPS)platform for calculation and analysis, and a visual molecular network was built with Cytoscape 3.8.2 software. On this basis, the chemical components of the Qinggu San reference sample were identified by fragmentation regularity of standard compounds, retention time, accurate relative molecular weight of HR-MS, characteristic fragment ions information, literature, and databases. Finally, a total of 105 chemical components were identified and speculated in the Qinggu San reference sample, including 19 iridoid glycosides, 23 flavonoids, 15 phenylpropanoids, 11 triterpene saponins, and 37 other components. Meanwhile, two of these components are potential new compounds. The method used in this study not only achieved rapid and accurate identification of chemical components in the Qinggu San reference sample and provided a scie-ntific basis for the study of pharmacological substances and quality control of Qinggu San compound preparations but also provided a refe-rence for the rapid identification of chemical components in traditional Chinese medicine compound preparations.

APPLICATION OF MODERN METHODS OF ANALYSIS FOR DETERMINATION OF POLLUTION AND IDENTIFICATION OF PLANT RAW MATERIALS

Quality control of herbal preparations is an important component to ensure the effectiveness and safety of their use. Phytochemical medicines are made from medicinal plant materials that may contain unwanted chemical compounds, so careful quality control must be performed to ensure their safety and efficacy. The success of quality control of herbal materials requires an integrated approach, i.e. a combination of various techniques and methods that allow analyzing the main classes of compounds. Various methods of analysis are used to overcome these difficulties. Today, the main chemical methods for determining the quality of medicinal products are chromatographic, in particular gas chromatography (GC), often combined with mass spectrometry (MS), liquid chromatography (HPLC), thin-layer chromatography (TLC), column chromatography (CC). Besides, HILIC is the optimal method for the analysis of polar and ionized compounds that are too strongly retained on polar stationary phases and/or poorly separated by standard chromatographic methods. TLC/HPTLC methods are traditionally used by the SPhU and the European Pharmacopoeia for identification of herbs and detection of impurities by visual assessment, as well as for semi-quantitative determination of compounds when comparing the intensity of the spot in the zone of the tested solution with spots in the zones of reference compounds. The mentioned methods have still remained the most acceptable for the identification of herbs, which is explained by the unique chromatographic profile of each plant or extract based on it. At the same time, the instrumental method of HPLC has advantages due to the possibility of quantitative determination of substances that fluoresce in UV or visible light. Nowadays, the direction of scientific research devoted to the optimization of the previously described analytical methods and the development of new ones for the identification of both herbs and herbal materials, as well as herbal remedies, becomes relevant. In addition, the development of methods for the quantitative determination of herbal compounds is a relevant scientific and practical direction.

The effect of ozone sterilization technology on the quality of Ganmaoling Granule based on HPLC fingerprint, chemometric analyses and multi-component content determination

Ganmaoling Granule (GMLG) is one of the most effective Chinese Patent Medicines (CPMs) which is applied to relieve the uncomfortable symptoms caused by the common cold. In this study, high-performance liquid chromatography (HPLC) combined with chemometric analyses and multi-component content determination were performed to preliminary investigate the effect of ozone sterilization technology on the quality of GMLG. The methodology validation and similarity analysis results showed that the analytical method was capable of complying with the demand of HPLC fingerprints, and 80 batches of GMLGs before and after ozone sterilization in four process stages had a high degree of similarity based on the values of similarity analysis (SA) was greater than 0.98. The results of hierarchical cluster analysis (HCA) and principal component analysis (PCA) showed that the GMLGs before and after ozone sterilization were divided into two categories, and the same batch of GMLGs was clustered into the same group. Meanwhile, the contents of linarin, caffeine, chlorpheniramine maleate and acetaminophen between 24 batches of GMLGs before and after ozone sterilization had no statistically significant differences (P > 0.05), which met the requirements of “Drug Standard of the People’s Republic of China”. In conclusion, the ozone sterilization technology had no obvious influence on the quality of GMLGs in four process stages, which provided a reference for the quality control of GMLG and other Chinese-western medicine compound preparations.

Monosaccharide composition analysis by 2D quantitative gsHSQCi

The physicochemical properties and biological activities of polysaccharides depend on their structures. Monosaccharide composition analysis is indispensable for the structural characterization of polysaccharides and is helpful in the quality control of polysaccharide preparation. Here, using a model mixture and tamarind seed polysaccharide as examples, we demonstrated that a quantitative 2D NMR method, gsHSQCi (three gradient-selective Heteronuclear Single Quantum Coherence spectra acquired with incremented repetition times, i = 1, 2, 3) can directly quantify a variety of monosaccharides in solution with adequate precision and accuracy, requiring no derivatization, postprocessing steps and column separation. Both anomeric and non-anomeric signals of monosaccharides can be utilized for content determination. More accurate quantification of fructose in a mixture containing nine monosaccharides is obtained, which is difficult to achieve by quantitative 1D 1HNMR and the common PMP-HPLC method (high-performance liquid chromatography through pre-column derivatization with 1-phenyl-3-methyl-5-pyrazolone) due to the peak overlapping and the poor derivatization efficiency, respectively. The results also revealed that Na[Fe(EDTA)] can serve as a proper relaxation-enhancing agent for saccharide samples to save experimental time. We expect that this approach can be applied as an alternative to analyzing the monosaccharide composition and be helpful in interpreting the structure of polysaccharides.

Pharmaceutical Preparation of Amrita Guggulu and its Clinical Efficacy on Vatarakta

This study scrabbles about into the pharmaceutical preparation of Amrita Guggulu, a traditional Ayurvedic formulation known for its therapeutic properties. The focus of the research is on assessing the clinical efficacy of Amrita Guggulu in managing Vatarakta, a condition characterized by vitiated Vata as well as Pitta and associated with inflammatory joint disorders. The pharmaceutical preparation involves meticulous formulation techniques, ensuring the quality and potency of the final product. Standardization parameters include the selection of authentic raw materials, adherence to traditional preparation methods and quality control measures. Clinical Trial Design: The clinical trial was designed as a randomized, double-blind study to assess the efficacy of Amrita Guggulu in patients diagnosed with Vatarakta. Participants were randomly assigned to either the treatment group receiving Amrita Guggulu group A or group B. A comprehensive clinical trial was conducted to evaluate the efficacy of Amrita Guggulu in patients diagnosed with Vatarakta. Key parameters such as joint pain, inflammation in joint, tenderness, burning sensation in affected area, skin rashes and tingling sensation were selected for the study. Overall improvement was assessed using standardized tools and patient-reported outcomes. Result: Preliminary findings indicate promising results, suggesting that Amrita Guggulu may play a significant role in alleviating symptoms associated with Vatarakta. The observed effects include a reduction in joint pain, improved joint function, and decreased inflammatory markers. Conclusion: This research contributes valuable insights into the pharmaceutical preparation of Amrita Guggulu and highlights its potential as an effective intervention for Vatarakta. On the basis of this clinical trial, we can say that S. Uric acid is not the confirmatory parameter for the decision of Vatarakta (gout). Further studies and long-term observations are recommended to solidify these findings and establish Amrita Guggulu as a viable therapeutic option in managing inflammatory joint disorders.

Bio-derived solvent based salt-responsive system for simultaneous extraction and in-situ enrichment of polysaccharides and phenolics from Carthamus tinctorius L. flower

The utilization of bio-derived solvents holds immense promise in the extraction of natural products. In the present study, a systematic evaluation was conducted to assess the performance of bio-derived solvents in simultaneously extracting polysaccharides and phenolic substances from Carthamus tinctorius L. flower. Among them, ethyl lactate (24.7%) exhibited superior efficacy. A comprehensive investigation was also conducted on the salt response behavior of ethyl lactate and its in-situ enrichment efficiency for polysaccharides and phenolics, demonstrating that the recovery yield, enrichment factor, and separation factor can be finely tuned by manipulating the system composition. Based on these findings, we have developed a highly efficient ultrasound-assisted method that is responsive to salt and enables simultaneous extraction and in situ enrichment of polysaccharides and phenolics. In comparison with the method in Chinese Pharmacopoeia (2020), the extraction yield of Carthamus tinctorius L. flower quality markers is increased by more than 1.14 times, while the extraction time is shortened by over 4 times. Additionally, the amount of solvent used is reduced by a factor of 5.73, eliminating the need for methanol and corrosive HCl that are harmful to the environment. The findings of this study will provide crucial theoretical guidance for the application of bio-derived solvents, demonstrating significant potential in terms of quality control and large-scale preparation of natural medicines.

Application of process analysis technology in traditional Chinese medicine manufacturing industry

In the traditional Chinese medicine(TCM) manufacturing industry, quality control determines the safety, effectiveness, and quality stability of the final product. The traditional quality control method generally carries out sampling off-line testing of drugs after the end of the batch production, which is incomprehensive, and it fails to find the problems in the production process in time. Process analysis technology(PAT) uses process testing, mathematical modeling, data analysis, and other technologies to collect, analyze, feedback, control, and continuously improve the critical quality attributes(CQA) in all aspects of the production of TCM preparations in real time. The application of PAT in the TCM manufacturing industry is one of the research hotspots in recent years, which has the advantages of real-time, systematic, non-destructive, green, and rapid detection for the production quality control of TCM preparations. It can effectively ensure the stability of the quality of TCM preparations, improve production efficiency, and play a key role in the study of the quantity and quality transfer law of TCM. Commonly used PAT includes near-infrared spectroscopy, Raman spectroscopy, online microwave, etc. In addition, the establishment of an online detection model by PAT is the key basic work to realize intelligent manufacturing in TCM production. Obtaining real-time online detection data through PAT and establishing a closed-loop control model on this basis are a key common technical difficulty in the industry. This paper adopted systematic literature analysis to summarize the relevant Chinese and foreign literature, policies and regulations, and production applications, and it introduced the development trend and practical application of PAT, so as to provide references for accelerating the application of PAT in the TCM manufacturing industry, the intelligent transformation and upgrading, and high-quality development of the TCM industry.

Malaria Slide Bank to Strengthen and Improve the Quality of Malaria Diagnosis: A National Slide Repository in India.

Malaria elimination is one of the top health care priorities in India, necessitating accessible and accurate diagnosis for effective treatment. A malaria slide bank in India is a collection of quality-controlled malaria-positive and -negative slides and is considered a vital asset for quality diagnosis. The collection of blood samples, preparation of blood smears, staining, quality control, molecular characterizations, and slide validation were carried out according to standard operating procedures in accordance with the WHO reference laboratory. The true count and parasite density per microliter were computed in accordance with WHO guidelines. Over 27 months, 48 batches (8,196 slides) were prepared. Overall, the majority of slide batches were Plasmodium vivax (45.9%; 22/48), followed by Plasmodium falciparum (25%; 12/48), malaria-negative infections (25%; 12/48), and mixed infections (4.1%; 2/48). All 48 batches passed internal validation by WHO-certified level-1 microscopists. For a batch, the true count was the median of the validators' counts (range, 111-280,795 parasites/µL). Except for mixed infections, the PCR results agreed with the verified microscopy results. Malaria slide bank slides would be a valuable tool for quality control, assurance, and microscopist training.

Edukasi Pengenalan Apoteker Cilik dan DAGUSIBU Pada Siswa SDN 4 di Desa Bahomoleo Kecamatan Bungku Tengah Kabupaten Morowali

Pharmacists are pharmaceutical graduates who have completed pharmacy education and have taken the pharmacist oath, carrying out pharmaceutical work including the manufacturing, quality control of pharmaceutical preparations, security, procurement, storage, distribution, or dispensing of drugs, drug management, prescription drug services, drug information services, as well as drug development, drug substances, and traditional medicines. Currently, the empowerment of health education programs and health services at an early age, especially at the elementary school level, has begun to develop. Children need to receive a lot of information about various professions to increase their insights and stimulate their learning spirit. Based on this, education activities of Junior Pharmacists (Apoteker Cilik) and DAGUSIBU (acronym for Obtaining, Using, Storing, and Disposing of drugs properly) were conducted for elementary school students to introduce the pharmacist profession and educate them on obtaining, using, storing, and disposing of drugs properly. The education was conducted for 5th and 6th-grade students at SDN 4 Bungku Tengah, Morowali, Central Sulawesi, involving 60 students. The method of this activity was through PowerPoint presentations, selection of speakers and materials for Junior Pharmacists and DAGUSIBU, and evaluation of education through question and answer sessions on the material. The evaluation results showed a positive outcome, namely an increase in knowledge about the pharmacist profession and proper drug DAGUSIBU.

[Artículo traducido] Detección y reducción de errores en la elaboración de la nutrición parenteral mediante control gravimétrico y de producto

ObjectiveTo analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. MethodsAll errors detected through quality control in the compounding of pediatric and adult parenteral nutrition between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. ResultsA total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (p < 0.05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (−0.59%) and product-related errors (−0.12%) (p < 0.05). ConclusionsComprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

An Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometric Method for the Simultaneous Determination of Eighteen Marker Compounds in the Traditional Herbal Formula Bopyeo-Tang.

Bopyeo-tang (BPT), comprising six medicinal plants, has been used for the treatment of respiratory diseases such as pulmonary fibrosis and chronic obstructive pulmonary disease. In this study, we developed and validated a quantitative method for the quality assessment of BPT using ultra-performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS). Eighteen marker compounds were separated on an Acquity UPLC BEH C18 reversed-phase column (2.1 mm × 100 mm, 1.7 μm) via gradient elution with a 0.1% aqueous formic acid-acetonitrile mobile phase. The multiple-reaction monitoring mode was used to improve analysis speed and accuracy. The coefficients of determination, limits of detection, and limits of quantitation of the 18 marker compounds were 0.9991-0.9996, 0.36-24.45 μg/L, and 1.07-73.35 μg/L, respectively. The recovery was 85.19-110.25%, and the relative standard deviation of precision was ≤9.01%. When applied to a typical BPT sample, the method revealed a range of concentrations from below the quantitative limit (one compound only) to a maximum of 3.20 mg/freeze-dried g. This method will be used for quality control of BPT preparations.

Validation of the efficacy of pooled serum for serum glucose inhouse quality control material in comparison with commercial internal quality control in clinical chemistry laboratory

BackgroundThis study aimed to create an in-house glucose quality control material for humans, addressing the challenge of obtaining high-cost commercially prepared quality control materials in developing countries. MethodsAn in-house quality control material for glucose was prepared using a pooled serum sample and analyzed using a fully automated chemistry analyzer following the ISO 80 guidelines. The mean, standard deviation (SD), and coefficient of variance were calculated from the first 30 days of measurement, and the variability was checked over eight months using SPSS software. The study used Pearson's correlation with a 95% confidence interval and a P-value less than 0.05, which was statistically significant. ResultsThe average mean ± SD of human serum glucose was 185.2 ± 8.4 mg/dL, indicating that the precision between each measurement was better. The prepared in-house quality control material was stable for approximately five months without any significant change in the serum glucose concentration (mg/dl) (p-value<0.05). ConclusionsThe study suggests that room-temperature, 2–8 °C, and −20 °C to −30 °C storage of human serum samples for glucose analysis is a viable option, with stable glucose concentrations for up to 30 days. Pooled serum is a cost-effective method for in-house quality control, especially in resource-limited laboratories.

Application and development of electronic sensing technologies represented by electronic nose in modern traditional Chinese medicine preparations

Odor is one of the important indicators evaluating the quality of traditional Chinese medicines. Research data has shown that there are increasing methods available for evaluating the odors of traditional Chinese medicines. Compared with conventional odor sensing techniques, electronic noses stand out for their convenience, high speed, and objectivity. The progress in the pharmaceutical technology of traditional Chinese medicines has provided new formulas and dosage forms for the innovative development in this field. The electronic nose with versatility can be customized to be equipped with a variety of cross-sensors, which can well satisfy the needs of the traditional Chinese medicine preparation technology. This study summarizes the characteristics, application status, and representative products of the current electronic nose, and analyzes the application and feasibility of electronic nose in the production of traditional Chinese medicine preparations based on the current status of odor evaluation. This review is expected to provide new methods, techno-logies, and ideas for electronic nose to play its unique role in the whole-process quality control and pharmaceutical process of traditional Chinese medicine preparations.

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control

ObjectiveTo analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. MethodsAll errors detected through quality control in the compounding of pediatric and adult parenteral nutritions between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. ResultsA total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (P < .05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (−0.59%) and product-related errors (−0.12%) (P < .05). ConclusionsComprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

Dose Determination and Administration of Bacterial Extracellular Vesicles for In Vivo Preclinical Studies.

Essentially all bacteria secrete nano-sized (~20-200nm) bacterial extracellular vesicles (bEVs) loaded with proteins, lipids, glycans, and nucleic acids. bEVs facilitate interactions among cells of the same species, different microbial species, and even with cells of multicellular organisms in the context of colonization or infection. Their interactions with host organism immune cell receptors vary depending on the producing bacterial species and are now being harnessed for the development of bEVs as a potential immunotherapeutic platform. Both basic/mechanistic and preclinical therapeutic development studies are thus increasing in number and require implementation of methods for multiparametric analytical characterization as well as in vivo administration in preclinical animal models of disease. We summarize a variety of analytical methods that can be used to calculate bEV dose for preparations made from diverse bacterial sources (including sterility testing, total protein concentration, particle concentration, and lipopolysaccharide concentration). We also describe basic methodology for intravenous administration of bEV preparations via tail vein injection in laboratory mice. Throughout the description of methodology, we highlight potential pitfalls and alternatives to further equip the reader for troubleshooting should challenges arise. Robust and reproducible characterization is a prerequisite of bEV preparation quality control and consistent dosing during preclinical development. This will allow for more streamlined testing of candidate therapeutic bEVs within a given research laboratory, and furthermore facilitate reproducibility of findings across laboratories.

Analysis Quality Control in Project Development Warehouse PT Santos Jaya Abadi Sidoarjo Using the Process Decision Program Chart Method

&lt;p dir="ltr"&gt;&lt;span&gt;Abstract: &lt;/span&gt;&lt;span&gt;The rapid development of the construction world today, competition in the construction world is also increasingly fierce so that assurance and control of quality are demanded higher. One form of realization in facing competition and meeting these demands is the preparation of quality control. The purpose of this study is to determine the implementation of quality control in warehouse construction projects and to determine the risk analysis of existing structural work so that quality control can be implemented better. This research begins with data collection through a questionnaire method distributed to construction project workers, with respondents being the project managers to workers. Furthermore, the collected questionnaire data was analyzed using BIM SPSS and the &lt;/span&gt;&lt;span&gt;process decision program chart &lt;/span&gt;&lt;span&gt;method. The results of the analysis show that the implementation of warehouse construction projects, especially in column and beam structure work, has a percentage of 76%, and in-floor plate work has a percentage of 72%. So that quality control is carried out effectively and level risk at a medium risk level.&lt;/span&gt;&lt;/p&gt;