Journal of AOAC International最新文献

{"title":"Rapid Dual-Gene Detection of Burkholderia gladioli and Subspecies Cocovenenans in Fresh Noodles and Tremella Using CRISPR-Cas12a/Cas13a.","authors":"Xurong Yao, Mansi Luo, Jianzhao Huang, Langjun Zhou, Binbin Zhang, Zhisen Liang, Xiuying Li","doi":"10.1093/jaoacint/qsae084","DOIUrl":"10.1093/jaoacint/qsae084","url":null,"abstract":"<p><strong>Background: </strong>Burkholderia gladioli pv. cocovenenans is a notable foodborne pathogen that poses a significant risk to food safety. Contaminated food requires distinct classification and treatment procedures for non-pathogenic B. gladioli and its pathogenic subspecies cocovenenans. Hence, establishing a rapid and sensitive detection method to distinguish them is necessary.</p><p><strong>Objective: </strong>In this study, we aimed to establish a method combining the CRISPR-Cas12a/Cas13a (Clustered regularly short palindromic repeats-CRISPR associated proteins 12a and 13a) dual system with recombinase-aided amplification for rapid, specific, and sensitive detection of non-pathogenic B. gladioli and pathogenic subspecies cocovenenans in food.</p><p><strong>Methods: </strong>First, an RAA (Recombinase-aided amplification)-CRISPR-Cas12a/Cas13a method was developed, and its feasibility was assessed. Next, specificity was analyzed using 23 strains of B. gladioli and 5 non-target strains. Following this, sensitivity was evaluated by preparing gradient dilutions of B. gladioli pv. cocovenenans bacterial solutions. Finally, real food test samples, including fresh noodles and tremella artificially contaminated with B. gladioli pv. cocovenenans, were utilized for method validation and sensitivity comparison.</p><p><strong>Results: </strong>The established RAA-CRISPR-Cas12a/Cas13a method exhibited high specificity and achieved 100% accuracy in detecting species B. gladioli and its subspecies cocovenenans. This rapid method could be finished within 45 min with a detection limit of 100 CFU/mL (Colony-forming units per millilter) for bacterial concentration. Additionally, it achieved detection limits of 102 CFU/g for fresh noodles and 103 CFU/g for tremella.</p><p><strong>Conclusion: </strong>The rapid RAA-CRISPR-Cas12a/Cas13a method demonstrated high specificity and sensitivity in detecting and distinguishing species B. gladioli and subspecies cocovenenans in both food test samples and post-cultivation colonies.</p><p><strong>Highlights: </strong>The RAA-CRISPR-Cas12a/Cas13a method presented in this study offers a novel molecular approach for the rapid, accurate, and sensitive detection of B. gladioli and its subspecies cocovenenans in foods.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"116-122"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"End Column Reverse Chromatography as a Novel Approach for Enhanced Separation: A Pilot Study.","authors":"Mostafa Soliman","doi":"10.1093/jaoacint/qsae080","DOIUrl":"10.1093/jaoacint/qsae080","url":null,"abstract":"<p><strong>Background: </strong>Currently, the most popular technique in gas chromatography (GC) is \"temperature programming,\" where the temperature increases from the start of the injection. This leads to faster elution of analytes compared to isothermal methods. However, isothermal methods are considered optimal for separating compounds with similar retention times. Another interesting technique that provides higher resolution is dynamic thermal gradient gas chromatography (TGGC), where separations are achieved as a decreasing thermal gradient. This gradually decreases the positive gas velocity. Nevertheless, it was proven that GC techniques with negative velocity gradients do not improve the resolution of compounds with nearly identical retention times.</p><p><strong>Objective: </strong>Optimizing a new GC approach to combine both the short time from positive temperature ramps programming, and the enhanced separation of the negative ramps of the TGGC, a model under the name of \"end column reverse chromatography\" (ECRC).</p><p><strong>Methods: </strong>The process simply consists of two steps: the first is a normal positive ramp from the start of the injection, and the second step is a negative thermal ramp at a time that is around the retention time of the first eluting peak. This will decrease the solute velocity almost solely for the second compound, leading to relatively enhanced separation.</p><p><strong>Results: </strong>The optimized ECRC method increased the resolution of two isomers (trans- and cis-chlordane) from 1 (slightly overlapping) in the case of temperature programming to 2.78 as shown in this study. This comes at the expense of the width and intensity of the peaks, where the intensity decreased about 17 and 12% for cis- and trans-chlordane, and the peak width increased with 37 and 77% for the same compounds, respectively.</p><p><strong>Conclusions: </strong>ECRC is a novel model for enhanced separation that comes with some drawbacks.</p><p><strong>Highlights: </strong>It can be an alternative approach to get a fast GC method with enhanced separation for isomers.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"112-115"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of Enzytec™ Liquid Citric Acid for Enzymatic Determination of Citric Acid in Selected Foods and Beverages: First Action 2024.02.","authors":"Markus Lacorn, Thomas Hektor","doi":"10.1093/jaoacint/qsae075","DOIUrl":"10.1093/jaoacint/qsae075","url":null,"abstract":"<p><strong>Background: </strong>Due to its excellent acidifier, antioxidant, and preservative properties, citric acid is added to or is a constituent in a broad range of foods and beverages. Its measurement should be performed to assure the food quality specifications are met.</p><p><strong>Objective: </strong>To validate the performance of the Enzytec™ Liquid Citric acid test kit for the determination in food and beverages such as wines, juices, and tomato products.</p><p><strong>Methods: </strong>The kit contains two ready-to-use components, which makes handling very easy and suitable for automation. Citrate is cleaved into oxaloacetate and acetate by citrate lyase. Oxaloacetate reacts to L-malate by L-malate dehydrogenase and reduced nicotinamide adenine dinucleotide (NADH). Pyruvate, spontaneously formed from oxaloacetate, is converted by L-lactate dehydrogenase to L-lactate. The NADH consumed is equivalent to the amount of citric acid converted and is measured at a wavelength of 340 nm within 20 min.</p><p><strong>Results: </strong>The test is specific to citric acid and shows no relevant interferences. Limit of detection and limit of quantification are 15 and 40 mg/L, respectively when using a test volume of 100 µL. The linear measurement range is from 40 to 1000 mg/L citric acid. Trueness was evaluated using materials from FAPAS, NIST, LGC, and two control wines from the German Wine Analysts. Matrix interference was evaluated by spiking tomato ketchup, tomato paste, orange juice, and carbonated beverages and resulted in recoveries around 100%. Intermediate precision is between 6.2 and 8.5% for matrixes with extraction and below 4% for matrixes measured directly. For automation, three applications with different test volumes and different measurement ranges were validated. Linearity is given from 8 mg/L up to 5 g/L (depending on the test volume).</p><p><strong>Conclusions: </strong>The method is robust and accurate for manual and automated applications. The method was approved as an AOAC Official Method of Analysis℠.</p><p><strong>Highlights: </strong>The ready-to-use components of the test kit have a shelf life of at least 24 months from the date of manufacture.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"29-46"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11761966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Q-Marker Prediction of Astragali Complanati Semen Based on Fingerprint and Network Pharmacology.","authors":"Xiaozhou Jia, Weisheng Lv, Cuijie Wei, Yueyi Liang, Jie Yang, Xuxuan Hou, Zhenyu Li, Xiangdong Chen, Mei Wei, Dongmei Sun","doi":"10.1093/jaoacint/qsae077","DOIUrl":"10.1093/jaoacint/qsae077","url":null,"abstract":"<p><strong>Background: </strong>Astragali Complanati, known in Chinese as Shayuanzi, is a common medicinal material in traditional Chinese medicine, mainly used for tonifying the kidney, supporting yang, consolidating essence, reducing urine, and other diseases.</p><p><strong>Objective: </strong>The ultra performance liquid chromatography (UPLC) fingerprint of Astragali Complanati Semen (ACS) was established, and the Q-markers of ACS were analyzed by network pharmacology.</p><p><strong>Methods: </strong>First, a UPLC fingerprint detection method was established for ACS, and the common peaks were identified by UPLC-MS/MS. The \"component-target-pathway\" network relationships of characteristic components of ACS were constructed by network pharmacology, and the potential quality markers (Q-markers) were predicted.</p><p><strong>Results: </strong>A total of 24 common peaks were identified from the UPLC fingerprint of ACS, and 12 chromatographic peaks were identified by UPLC-MS/MS. A total of 12 Q-markers candidate components were screened out. Through network pharmacological analysis, it is predicted that myricetin 3-O-β-D-xylopyranosyl-(1-2)-[α-L-rhamnopyranosyl-(1-6)]-β-D-glucopyranoside, myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside, myricetin 3-β-D-glucopyranoside, cannabiscitrin, laricitrin-3-O-glucoside, leucoside, complanatoside B, complanatuside, complanatuside 6''-malonate, clycosin, rhamnocitrin 3-O-β-D-apiofuranosyl(1→2)-β-D-glucopyranoside, and 3-O-[5'''-O-feruloyl-beta-D-apiofuranosyl(1'''->2'')-beta-D-glucopyranosyl] rhamnocitrin are the Q-markers of ACS.</p><p><strong>Conclusion: </strong>The method established in this study was accurate, reliable, simple, and practical and could be used as a reference method for ACS quality detection. Twelve Q-markers selected by network pharmacology could provide support and references for ACS QC.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"78-89"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of Soybean GMO Events Using Two Multiplex Droplet Digital PCR Assays.","authors":"Tigst Demeke, Monika Eng","doi":"10.1093/jaoacint/qsae082","DOIUrl":"10.1093/jaoacint/qsae082","url":null,"abstract":"<p><strong>Background: </strong>Detection methods for GMO events are required because of regulatory compliance requirements. Efficient detection and quantification of GMO events saves time and resources. Multiplex digital PCR (dPCR) allows detection and quantification of more than one GMO event at the same time.</p><p><strong>Objective: </strong>The study used two tetraplex droplet digital PCR (ddPCR) assays for the detection of 19 soybean GMO events.</p><p><strong>Methods: </strong>Two multiplex dPCR assays were developed and optimized for the detection of 19 soybean GMO events. The first tetraplex ddPCR assay contained four element-specific targets commonly found in GMO plants (P-35S, T-nos, tE9, and Pat). The second event-specific tetraplex ddPCR assay targeted four soybean GMO events that are not detected with the element-specific tetraplex ddPCR (CV127, DP305423, MON87701, and MON87751).</p><p><strong>Results: </strong>The element-specific tetraplex ddPCR assay detected all the expected 15 soybean GMO events. The element-specific tetraplex ddPCR assay also detected selected soybean GMO events at the 0.01% level. The event-specific tetraplex ddPCR assay was successfully used to quantify the four soybean GMO events at the 0.1, 1, 2, and 5% levels. The event-specific tetraplex ddPCR assay also detected the four soybean GMO events at the 0.01% level.</p><p><strong>Conclusions: </strong>The two tetraplex ddPCR assays can be used for the detection of 19 soybean GMO events.</p><p><strong>Highlights: </strong>An element-specific tetraplex ddPCR assay was used to detect 15 soybean GMO events, and an event-specific tetraplex ddPCR assay was used to detect and quantify four soybean GMO events that are not detected by the element-specific ddPCR assay.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"23-28"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11761968/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modernizing USP Melatonin Liquid Chromatographic Analyses for Increased Throughput and Reduced Environmental Impact.","authors":"Jinchuan Yang, Paul D Rainville, Stephanie N Harden","doi":"10.1093/jaoacint/qsae098","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae098","url":null,"abstract":"<p><strong>Background: </strong>Melatonin supplements are often used to alleviate jetlag and other sleep-depletion related disorders. Recent studies found large inconsistencies between labeled values and actual contents of melatonin within products, which has led to concerns over the quality of melatonin supplements. In order to facilitate the quality control testing of melatonin supplements, an improved and more modern approach to the liquid chromatographic analysis of melatonin is required. In addition, growing public concern over the environmental footprint of analytical laboratories exacerbates the need to modernize legacy analytical procedures with more eco-friendly or greener approaches.</p><p><strong>Objective: </strong>This study aims to optimize the routine liquid chromatographic analyses that are prescribed in the US Pharmacopeia (USP) melatonin monograph on a High Performance Liquid Chromatography (HPLC) system without fundamentally modifying the methods.</p><p><strong>Method: </strong>The melatonin assay and the melatonin related compounds (impurities) test were optimized on a C18 column packed with 2.5 µm particles. The column length and the gradient elution parameters were adjusted following the guidelines on Adjustment of Chromatographic Conditions in USP General Chapter <621>. The mobile phase compositions were optimized to meet the system suitability requirements that were specified in the USP melatonin monograph. The flow rate was optimized for better separation efficiency.</p><p><strong>Results: </strong>The optimized HPLC methods not only met the USP system suitability requirements in relative retention time (RRT), resolution, and relative standard deviation (RSD), but also demonstrated excellent linearity, sensitivity, accuracy, precision (repeatability), and would have a lower environmental impact.</p><p><strong>Conclusions: </strong>The optimized HPLC methods for assay of melatonin and test of its related compounds achieved significantly increased throughput and a reduced environmental impact, without fundamentally modifying the methods.</p><p><strong>Highlights: </strong>The optimized HPLC methods are significantly faster and more eco-friendly. These methods can be implemented on HPLC systems without a full re-validation.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of the QuEChERSER Method for 245 Pesticides and Environmental Contaminants in Barley and Hemp by Low-Pressure GC: Comparison of Triple Quadrupole MS/MS and Orbitrap HRMS for Qualitative and Quantitative Analysis.","authors":"Nicolás Michlig, Steven J Lehotay","doi":"10.1093/jaoacint/qsae093","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae093","url":null,"abstract":"<p><strong>Background: </strong>Monitoring labs are a fundamental link in the food safety chain, and regulatory demands in a competitive economy call for analytical methods that are simpler, faster, more rugged, and broader in scope. The QuEChERSER mega-method introduced in 2021 meets these monitoring needs, which includes high sample throughput, automated cleanup of extracts, and fast low-pressure gas chromatography (LPGC).</p><p><strong>Objective: </strong>The goal of this work was to extend the QuEChERSER method to additional matrices and more analytes using LPGC, including comparison of the analytical performances of two different mass spectrometric (MS) analyzers: triple quadrupole tandem MS/MS and orbital ion trap (orbitrap) high-resolution (HR)MS.</p><p><strong>Methods: </strong>The QuEChERSER mega-method was validated for 245 pesticides and environmental contaminants in barley grains and hemp pellets using automated instrument top sample preparation (ITSP) coupled with LPGC-MS/MS or LPGC-HRMS (orbitrap).</p><p><strong>Results: </strong>Targeted MS/MS detection proved to be more sensitive than orbitrap using full data acquisition, leading to lower limits of quantification (LOQs) with more analytes yielding acceptable recoveries (70-120%) and repeatabilities (RSDs <20%). In barley, 89% of the compounds met validation criteria in MS/MS and 74% in HRMS, which in hemp were 81% and 66%, respectively. Qualitatively, orbitrap HRMS yielded 1% false positives compared to 3-4% in MS/MS, but due to the higher LOQs, the rates of false negatives were 14-17% in orbitrap vs. 6-10% in MS/MS for the different matrices.</p><p><strong>Conclusion: </strong>The QuEChERSER mega-method including ITSP+LPGC coupled with MS/MS or orbitrap analysis is a robust approach for multiple applications. In the comparison, MS/MS outperformed the orbitrap in terms of sensitivity, but the orbitrap advantages of easier method development, greater selectivity, and possibility for nontargeted/retrospective analysis permit even broader expansion of analytical scope in the future.</p><p><strong>Highlights: </strong>ITSP+LPGC- MS/MS or HRMS (orbitrap) analysis as part of the QuEChERSER mega-method is a useful and efficient way to monitor for contaminants in foods.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142683994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proof of Concept: Autonomous Machine Vision Software for Botanical Identification.","authors":"Nathan Stern, Jonathan Leidig, Gregory Wolffe","doi":"10.1093/jaoacint/qsae091","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae091","url":null,"abstract":"<p><strong>Background: </strong>HPTLC is a widely used and accepted technique for identification of botanicals. Current best practices involve subjective comparison of HPTLC-generated images between test samples and certified botanical reference materials based on specific bands.</p><p><strong>Objective: </strong>This research was designed to evaluate the potential of cutting-edge machine vision-based machine learning techniques to automate identification of botanicals using native HPTLC image data.</p><p><strong>Method: </strong>HPTLC images from Ginger and its closely related species and common adulterants were used to create large, synthetic datasets using a deep conditional generative adversarial network. This synthetic dataset was used to train and validate a deep convolutional neural network capable of automatically identifying new HPTLC image data. Performance of both neural networks was evaluated over time using appropriate loss functions as an indicator of their progress during learning. Validation of the overall system was measured via the accuracy of the learned model when applied to real HPTLC data.</p><p><strong>Results: </strong>The machine vision system was able to generate realistic synthetic HPTLC images that were successfully used to train a deep convolutional neural network. The resulting learned model achieved high-accuracy identification from HPTLC images corresponding to Ginger and six other related species.</p><p><strong>Conclusions: </strong>A proof-of-concept HPTLC image-based machine vision system for the identification of botanicals was proven to be feasible and a fully working prototype was validated for several species related to Ginger.</p><p><strong>Highlights: </strong>This use of an autonomous machine-vision system for botanical identification removed the subjectivity inherent to human-based evaluation. The learned model also accurately evaluated botanical HPTLC images significantly faster than its human counterpart, which could save both time and resources.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FraMiTrACR: A Sustainable and Economical Technology for Analytical Sample Preparation.","authors":"Jan-Michael Steils, Alexander Kaluza, Klaus Schöne, John Cashman, Christian Baumgartner, Maren Lang, Melina Kraus","doi":"10.1093/jaoacint/qsae092","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae092","url":null,"abstract":"<p><strong>Background: </strong>There are several globally recognized methods for preparing laboratory samples. Of these, the QuEChERS and QuPPe methods are commonly used for food laboratory sample preparation. As an alternative, we developed the fractionation method using FraMiTrACR.</p><p><strong>Objective: </strong>We present a life cycle assessment for the QuEChERS-, QuPPe- and FraMiTrACR methods. Our objective was to collect data to evaluate the carbon footprint of each method. However, as the ecological factors alone do not inform suitability of any given method, we also evaluated economic factors.</p><p><strong>Methods: </strong>Our life cycle assessments followed ISO 14040/44 to determine the carbon footprint of each method. Also, we have analyzed existing data to support our comparison of all three methods.</p><p><strong>Results: </strong>The mass of consumables and packaging for our FraMiTrACR method was observed to decrease by 45% and 34% from those required for the QuPPe and QuEChERS methods, respectively. Furthermore, we calculated a 43% reduction in carbon footprint when using FraMiTrACR compared to QuPPe and a 31% reduction compared to QuEChERS. In addition, we determined that our method offers time savings >87% and >71% compared to QuEChERS and QuPPe, respectively. The main economic benefit of FraMiTrACR comes from 84% and 70% labor cost savings compared to QuEChERS and QuPPe, respectively. The laboratory using fractionation method can process 320 samples with FraMiTrACR within 8 hours, an 87% increase in potential compared to QuEChERS and a 71% increase compared to QuPPe.</p><p><strong>Conclusions: </strong>Fractionation using FraMiTrACR is a more sustainable method for analytical sample preparation, offering the same quality of results and far-reaching economic advantages.</p><p><strong>Highlights: </strong>In comparison, FraMiTrACR uses up to 45% less consumables and packaging by weight and a reduction in kg CO2eq of up to 43%. In addition, the fractionation method offers up to 85% time savings and up to an 84% reduction in labor cost per sample.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Alternative Microbiological Validation for an Online Water Bioburden Analyzer.","authors":"Olivia L Venhuizen, Cynthia E Martindale, Feng Jin Liew, James Cannon, Arundhati Samanta, Mike J Scaramozzino","doi":"10.1093/jaoacint/qsae050","DOIUrl":"10.1093/jaoacint/qsae050","url":null,"abstract":"<p><strong>Background: </strong>The Mettler-Toledo 7000RMS analyzer is a bio-fluorescent particle counter (BFPC) used to monitor real-time bioburden results from purified water (PW).</p><p><strong>Objective: </strong>Validation of the analyzer using 13 microorganisms and a low-intensity, fluorescent, polystyrene bead.</p><p><strong>Methods: </strong>During the execution of the validation, a laboratory water system that met PW quality standards was connected to the 7000RMS, and a syringe pump was used to introduce various concentrations of microorganisms and fluorescent polystyrene beads to the analyzer. Samples were collected and tested via the traditional membrane filtration (MF) method and the colony-forming unit (CFU) plate count results were compared to the auto-fluorescent unit (AFU) of the 7000RMS analyzer. The validation study was designed to follow the guidance in United States Pharmacopeia (USP) Chapter <1223>, European Pharmacopeia (EP) Chapter 5.1.6, and parenteral drug association (PDA) Technical Report 33. Concepts and strategies were adapted from EP Chapter 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests, EP Chapter 10.2, EP Chapter 2.6.1 Sterility, USP Chapter <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests, USP Chapter <71> Sterility Tests, and Japanese Pharmacopoeia (JP) General Information Chapter G8 Water: Quality Control of Water for Pharmaceutical Use.</p><p><strong>Results: </strong>All pre-determined validation acceptance criteria for accuracy, specificity, precision, LOD, LOQ, linearity, and range were met.</p><p><strong>Conclusions: </strong>The 7000RMS demonstrated performance equivalence to the MF method per USP <1223> but characteristically lacked correlation to the CFU.</p><p><strong>Highlights: </strong>This validation approach highlights the superior capabilities of the 7000RMS when compared against the traditional compendial MF testing method for PW.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"997-1017"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141452477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}