Risks of dairy derived excipients in medications for lactose intolerant and cow milk protein allergic patients.

The use of lactose and cow milk protein (CMP) as potential allergens in pharmaceuticals and their ability to cause allergic reactions remains a significant concern in medicine. Lactose, a common pharmaceutical excipient due to its inert, inexpensive, and stable properties, is found in many prescription-only and over-the-counter medications. However, despite their widespread use, individuals with lactose intolerance (LI) or cow milk protein allergy (CMPA) may experience adverse reactions to these excipients. This study investigated the prevalence of lactose and other dairy-derived ingredients in pharmaceuticals marketed in Portugal. Using the Summary of Product Characteristics (SmPC) from the INFOMED database, various medications, including analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), and antiasthmatics, were analyzed. Results showed a high prevalence of dairy-derived excipients, particularly in antiasthmatic drugs (62.6%) and NSAIDs (39%). Although CMP are not explicitly mentioned in SmPCs, the presence of lactose as an ingredient poses a risk of cross-contamination. The findings emphasize the need for healthcare professionals to be aware of potential allergens in medications and the importance of developing lactose-free alternatives to ensure the safety of patients with LI and CMPA. Further research is required to assess the safety and implications of lactose in medicines for these populations.

The combination of allicin with domiphen is effective against microbial biofilm formation.

Background: Microorganisms in biofilms are particularly difficult to control because of their increased survival and antibiotic resistance. Allicin and domiphen were employed to inhibit the microbial growth and biofilm formation of Staphylococcus aureus, Escherichia coli, and Candida albicans strains. Methods: Broth microdilution method and checkerboard assay were conducted to determine the efficacy of allicin combined with domiphen against S. aureus, E. coli, and C. albicans. Microbial biofilm formation was measured using the crystal violet staining method and fluorescence microscopy. And the total viable count of the biofilm cells on material surface after the treatment with antimicrobial reagents was calculated with the plate count technique. Results: The two drugs showed synergistic effects against the pathogens with a fractional bactericidal concentration of less than 0.38. The combination of 64 µg/mL allicin with 1 µg/mL domiphen dispersed over 50% of the biofilm mass of S. aureus, E. coli, and C. albicans. In addition, the drug combination reduced the total viable counts of E. coli and C. albicans biofilm cells on stainless steel and polyethylene surfaces by more than 102 CFU/mL. Conclusion: The combination of allicin and domiphen is an effective strategy for efficiently decreasing biofilms formation on various industrial materials surfaces.

Potential of Powder Rheology for Detecting Unforeseen Cross-Contamination of Foreign Active Pharmaceutical Ingredients.

Unexpected cross-contamination by foreign components during the manufacturing and quality control of pharmaceutical products poses a serious threat to the stable supply of drugs and the safety of customers. In Japan, in 2020, a mix-up containing a sleeping drug went undetected by liquid chromatography during the final quality test because the test focused only on the main active pharmaceutical ingredient (API) and known impurities. In this study, we assessed the ability of a powder rheometer to analyze powder characteristics in detail to determine whether it can detect the influence of foreign APIs on powder flow. Aspirin, which was used as the host API, was combined with the guest APIs (acetaminophen from two manufacturers and albumin tannate) and subsequently subjected to shear and stability tests. The influence of known lubricants (magnesium stearate and leucine) on powder flow was also evaluated for standardized comparison. Using microscopic morphological analysis, the surface of the powder was observed to confirm physical interactions between the host and guest APIs. In most cases, the guest APIs were statistically detected due to characteristics such as their powder diameter, pre-milling, and cohesion properties. Furthermore, we evaluated the flowability of a formulation incorporating guest APIs for direct compression method along with additives such as microcrystalline cellulose, potato starch, and lactose. Even in the presence of several additives, the influence of the added guest APIs was successfully detected. In conclusion, powder rheometry is a promising method for ensuring stable product quality and reducing the risk of unforeseen cross-contamination by foreign APIs.

Evaluating Effectiveness of Multi-Component Waste Plastic Bags on Bitumen Properties: Physical, Rheological, and Aging.

This study examines the applicability of an unknown composition waste plastic bag sample as bitumen modifier. The waste components were initially characterized to identify the type of plastics and the level of impurity. Asphalt binder performance was examined for rutting, thermal, and age resistance. The results revealed that the waste plastic bags, predominantly consisted of Low-Density Polyethylene (LDPE) and Linear Low-Density Polyethylene (LLDPE) and contained 6.1% impurities. The binder tests indicated that the waste plastic bags enhanced the rutting resistance of bitumen by one grade, with its modification more similar to LLDPE, rather than LDPE. The thermal degradation and aging properties of the modified binders demonstrated that the bitumen modified by the waste plastic bags exhibited slightly lower resistance to temperature and aging compared to virgin LDPE and LLDPE. This was attributed to the impurities contained in the waste plastic. In conclusion, the analyzed waste plastic bags proved to be suitable for use in binder modification, presenting a viable alternative to virgin LLDPE.

Comparison of permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs) - Evidence of a robust approach.

Permitted Daily Exposure Limits (PDEs) are set for Active Pharmaceutical Ingredients (APIs) to control cross-contamination when manufacturing medicinal products in shared facilities. With the lack of official PDE lists for pharmaceuticals, PDEs have to be set by each company separately. Although general rules and guidelines for the setting of PDEs exist, inter-company variations in the setting of PDEs occur and are considered acceptable within a certain range. To evaluate the robustness of the PDE approach between different pharmaceutical companies, data on PDE setting of five marketed APIs (amlodipine, hydrochlorothiazide, metformin, morphine, and omeprazole) were collected and compared. Findings show that the variability between PDE values is within acceptable ranges (below 10-fold) for all compounds, with the highest difference for morphine due to different Point of Departures (PODs) and Adjustment Factors (AFs). Factors of PDE variability identified and further discussed are: (1) availability of data, (2) selection of POD, (3) assignment of AFs, (4) route-to-route extrapolation, and (5) expert judgement and differences in company policies. We conclude that the investigated PDE methods and calculations are robust and scientifically defensible. Additionally, we provide further recommendations to harmonize PDE calculation approaches across the pharmaceutical industry.

Microbial dynamics of South Korean beef and surroundings along the supply chain based on high-throughput sequencing.

Microbiological safety and quality of beef is crucial as beef can serve as a reservoir for a variety of bacteria, including spoilage-related and foodborne pathogens. Controlling microbial contamination is a critical aspect of food quality and safety, but it is difficult to prevent as there are several potential sources of contamination from production to distribution. In this study, the microbiological ecology of cattle/beef and associated environmental samples (n = 69) were trace-investigated to reveal microbiome shifts in cattle/beef and possible cross-contaminants throughout the entire supply chain using 16S rRNA gene sequencing. Pseudomonas, Psychrobacter, and Acinetobacter, known as spoilage bacteria, opportunistic pathogens, or antibiotic-resistant bacteria, were the main microorganisms present in cattle/beef, and Staphylococcus became abundant in the final products. The dominance of Acinetobacter and Pseudomonas was noticeable in the slaughtered carcasses and slaughterhouse environment, indicating that the slaughterhouse is a critical site where hygienic practices are required to prevent further contamination. Taxonomic similarities between cattle/beef and several environmental samples, as well as diversity analysis, presented a high potential for microbial transmission. Source tracking identified environmental samples that primarily contributed to the microbiota of cattle/beef. Farm floor (48%), workers' gloves (73%), and carcass splitters (20%) in the slaughterhouse were found to be major sources influencing the microbiome of cattle/beef at the farm, slaughterhouse, and processing plant, respectively. These findings demonstrated the dynamics of bacterial communities in cattle/beef according to stage and detected potential contamination sources, which may aid in a better understanding and control of microbial transmission in beef production.

Comprehensive strategies for controlling Listeria monocytogenes biofilms on food-contact surfaces.

Listeria monocytogenes biofilms formed on food-contact surfaces within food-processing facilities pose a significant challenge, serving as persistent sources of cross-contamination. In this review, we examined documented cases of foodborne outbreaks and recalls linked to L. monocytogenes contamination on equipment surfaces and in the food production environment, provided an overview of the prevalence and persistence of L. monocytogenes in different food-processing facilities, and discussed environmental factors influencing its biofilm formation. We further delved into antimicrobial interventions, such as chemical sanitizers, thermal treatments, biological control, physical treatment, and other approaches for controlling L. monocytogenes biofilms on food-contact surfaces. This review provides valuable insights into the persistent challenge of L. monocytogenes biofilms in food processing, offering a foundation for future research and practical strategies to enhance food safety.

From wheat grain to flour: a review of potential sources of enteric pathogen contamination in wheat milled products.

The number of food safety issues linked to wheat milled products have increased in the past decade. These incidents were mainly caused by the contamination of wheat-based products by enteric pathogens. This manuscript is the first of a two-part review on the status of the food safety of wheat-based products. This manuscript focused on reviewing the available information on the potential pre-harvest and post-harvest sources of microbial contamination, and potential foodborne pathogens present in wheat-based products. Potential pre-harvest sources of microbial contamination in wheat included animal activity, water, soil, and manure. Improper grain storage practices, pest activity, and improperly cleaned and sanitized equipment are potential sources of post-harvest microbial contamination for wheat-based foods. Raw wheat flour products and flour-based products are potentially contaminated with enteric pathogens such as Shiga toxin-producing E. coli (STECs), and Salmonella at low concentrations. Wheat grains and their derived products (i.e., flours) are potential vehicles for foodborne illness in humans due to the presence of enteric pathogens. A more holistic approach is needed for assuring the food safety of wheat-based products in the farm-to-table continuum. Future developments in the wheat supply chain should also be aimed at addressing this emerging food safety threat.

Nasopharyngeal Carcinoma Cell Lines: Reliable Alternatives to Primary Nasopharyngeal Cells?

Nasopharyngeal carcinoma (NPC) is a type of cancer that originates from the mucosal lining of the nasopharynx and can invade and spread. Although contemporary chemoradiotherapy effectively manages the disease locally, there are still challenges with locoregional recurrence and distant failure. Therefore, it is crucial to have a deeper understanding of the molecular basis of NPC cell movement in order to develop a more effective treatment and to improve patient survival rates. Cancer cell line models are invaluable in studying health and disease and it is not surprising that they play a critical role in NPC research. Consequently, scientists have established around 80 immortalized human NPC lines that are commonly used as in vitro models. However, over the years, it has been observed that many cell lines are misidentified or contaminated by other cells. This cross-contamination leads to the creation of false cell lines that no longer match the original donor. In this commentary, we discuss the impact of misidentified NPC cell lines on the scientific literature. We found 1159 articles from 2000 to 2023 that used NPC cell lines contaminated with HeLa cells. Alarmingly, the number of publications and citations using these contaminated cell lines continued to increase, even after information about the contamination was officially published. These articles were most commonly published in the fields of oncology, pharmacology, and experimental medicine research. These findings highlight the importance of science policy and support the need for journals to require authentication testing before publication.

Antibacterial Activity of Oregano (Origanum vulgare L.) Essential Oil Vapors against Microbial Contaminants of Food-Contact Surfaces.

The antimicrobial effect of eight essential oils' vapors against pathogens and spoilage bacteria was assayed. Oreganum vulgare L. essential oil (OVO) showed a broad antibacterial effect, with Minimum Inhibitory Concentration (MIC) values ranging from 94 to 754 µg cm-3 air, depending on the bacterial species. Then, gaseous OVO was used for the treatment of stainless steel, polypropylene, and glass surfaces contaminated with four bacterial pathogens at 6-7 log cfu coupon-1. No viable cells were found after OVO treatment on all food-contact surfaces contaminated with all pathogens, with the exception of Sta. aureus DSM 799 on the glass surface. The antimicrobial activity of OVO after the addition of beef extract as a soiling agent reduced the Sta. aureus DSM 799 viable cell count by more than 5 log cfu coupon-1 on polypropylene and glass, while no viable cells were found in the case of stainless steel. HS-GC-MS analysis of the headspace of the boxes used for the antibacterial assay revealed 14 different volatile compounds with α-Pinene (62-63%), and p-Cymene (21%) as the main terpenes. In conclusion, gaseous OVO could be used for the microbial decontamination of food-contact surfaces, although its efficacy needs to be evaluated since it depends on several parameters such as target microorganisms, food-contact material, temperature, time of contact, and relative humidity.

Influence of a nanoscale coating on plucking fingers and stainless steel on attachment and detachment of Salmonella Enteritidis, Escherichia coli and Campylobacter jejuni.

Gastroenteritis caused by Campylobacter represents the most common reported foodborne bacterial illness worldwide, followed by salmonellosis. Both diseases are often caused by the consumption of contaminated, insufficiently heated poultry meat. This can result from contamination of the meat during the slaughtering processes. Food contact surfaces like stainless steel or plucking fingers contribute significantly to cross-contamination of poultry carcasses. Modification of these surfaces could lead to a reduction of the bacterial burden, as already proven by successful application in various food industry sectors, such as packaging.In this study, nanoscale silica-coated and uncoated stainless-steel surfaces and plucking fingers were compared on a pilot scale regarding attachment and detachment of Campylobacter jejuni, Salmonella Enteritidis and Escherichia coli.The bacteria did not adhere less to the coated plucking fingers or stainless-steel sections than to the uncoated ones. The coating also did not lead to a significant difference in detachment of Campylobacter jejuni, Salmonella Enteritidis and Escherichia coli from the investigated surfaces compared to the uncoated ones.Our study did not reveal any differences between the coated and uncoated surfaces with regard to the investigated bacteria. In order to achieve a better adaptation of the coating to slaughterhouse conditions, future studies should focus on its further development based on the investigation of specific coating parameters.

Analysis of two cross-contamination cases of Campylobacter jejuni foodborne disease in fragile subjects in the territory of a Local Health Authority in Tuscany, Italy.

Campylobacteriosis is the most reported foodborne disease in the European Union, with more than 100,000 confirmed cases annually. Human infection can be caused by a low infectious dose, and in fragile populations, the food disease can manifest itself in acute and severe forms. This study aims to analyze two cases of campylobacteriosis in fragile people caused by Campylobacter jejuni in 2023 in Tuscany and the actions of the Local Health Competent Authority. From the results of the related investigations, it was possible to attribute both cases of foodborne diseases to unsafe food management during preparation/administration. Given the peculiar characteristics of the etiological agent, it is necessary to focus the attention of the population, especially those who deal with fragile subjects, on the good hygiene practices to be followed both at home and in collective catering.

A comprehensive performance evaluation, comparison, and integration of computational methods for detecting and estimating cross-contamination of human samples in cancer next-generation sequencing analysis.

Cross-sample contamination is one of the major issues in next-generation sequencing (NGS)-based molecular assays. This type of contamination, even at very low levels, can significantly impact the results of an analysis, especially in the detection of somatic alterations in tumor samples. Several contamination identification tools have been developed and implemented as a crucial quality-control step in the routine NGS bioinformatic pipeline. However, no study has been published to comprehensively and systematically investigate, evaluate, and compare these computational methods in the cancer NGS analysis. In this study, we comprehensively investigated nine state-of-the-art computational methods for detecting cross-sample contamination. To explore their application in cancer NGS analysis, we further compared the performance of five representative tools by qualitative and quantitative analyses using in silico and simulated experimental NGS data. The results showed that Conpair achieved the best performance for identifying contamination and predicting the level of contamination in solid tumors NGS analysis. Moreover, based on Conpair, we developed a Python script, Contamination Source Predictor (ConSPr), to identify the source of contamination. We anticipate that this comprehensive survey and the proposed tool for predicting the source of contamination will assist researchers in selecting appropriate cross-contamination detection tools in cancer NGS analysis and inspire the development of computational methods for detecting sample cross-contamination and identifying its source in the future.

Distribution and characteristics of bacteria on the hand during oropharyngeal swab collection: Which handwashing points are affected?

AIMS: To identify the contaminated areas of the hand collection and analyse the distribution characteristics of bacteria in the hand after swab collection. DESIGN: This study used a cross-sectional design. METHODS: A cross-sectional study sampling 50 pairs of hands (sampling hand and auxiliary hand) of healthcare workers was performed. Ten samples were collected from each participant. The optimal hand hygiene rates and bacterial colony counts of the whole hand and different hand sections without hand hygiene were identified as the primary outcomes. RESULTS: The optimal hand hygiene rates of the sampling hand and auxiliary hand were 88.8% (222/250) and 91.6% (229/250), respectively. The lowest optimal hand hygiene rates for the sampling hand and the auxiliary hand were both on the dorsal side of the finger and the dorsum of the hand (86.0%, 86.0% vs. 90.0%, 86.0%); the optimal hand hygiene rates for both sites of the sampling hand were 86.0% (43/50), and the optimal hand hygiene rates for the auxiliary hand were 90.0% (45/50) and 86.0% (43/50). The bacteria colony counts did not differ between the sampling hands and auxiliary hand. CONCLUSIONS: The dorsal side of the finger and dorsum of the hand were the most likely to be contaminated during oropharyngeal swab collection. Therefore, it is essential to pay extra attention to hand hygiene care of these two sites during the collection process to minimize the risk of cross-contamination. REPORTING METHOD: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were adopted in this study.

Predictive modeling of Salmonella spp. growth behavior in cooked and raw chicken samples: Real-time PCR quantification approach and model assessment in different handling scenarios.

The increasing prevalence of Salmonella contamination in poultry meat emphasizes the importance of suitable predictive microbiological models for estimating Salmonella growth behavior. This study was conducted to evaluate the potential of chicken juice as a model system to predict the behavior of Salmonella spp. in cooked and raw chicken products and to assess its ability to predict cross-contamination scenarios. A cocktail of four Salmonella serovars was inoculated into chicken juice, sliced chicken, ground chicken, and chicken patties, with subsequent incubation at 10, 15, 20, and 25°C for 39 h. The number of Salmonella spp. in each sample was determined using real-time polymerase chain reaction. Growth curves were fitted into the primary Baranyi and Roberts model to obtain growth parameters. Interactions between temperature and growth parameters were described using the secondary Ratkowsky's square root model. The predictive results generated by the chicken juice model were compared with those obtained from other chicken meat models. Furthermore, the parameters of the chicken juice model were used to predict Salmonella spp. numbers in six worst-case cross-contamination scenarios. Performance of the chicken juice model was evaluated using the acceptable prediction zone from -1.0 (fail-safe) to 0.5 (fail-dangerous) log. Chicken juice model accurately predicted all observed data points within the acceptable range, with the distribution of residuals being wider near the fail-safe zone (75%) than near the fail-dangerous zone (25%). This study offers valuable insights into a novel approach for modeling Salmonella growth in chicken meat products, with implications for food safety through the development of strategic interventions. PRACTICAL APPLICATION: The findings of this study have important implications in the food industry, as chicken juice could be a useful tool for predicting Salmonella behavior in different chicken products and thus reducing the risk of foodborne illnesses through the development of strategic interventions. However, it is important to recognize that some modifications to the chicken juice model will be necessary to accurately mimic all real-life conditions, as multiple factors particularly those related to food processing can vary between different products.

Determination of four aminoglycoside antibiotics and spectinomycin in feed at cross-contamination level: Development and in-house validation of a LC-MS/MS method for enforcing EU Regulation.

Combating antimicrobial resistance is a top priority worldwide involving a concerted action by several high-level institutions and organisations in the health sector. To ensure that a meaningful progress is achieved, several campaigns and political initiatives have been launched targeting the health professionals, the industry, the farmers, and the general public. The Regulation (EU) 2019/4 on medicated feed contains provisions for the limitation and control of the contamination of non-target compound feed with 24 antimicrobials. The purpose of this work was to develop a reliable and effective method for the determination of four aminoglycoside antibiotics (apramycin, paromomycin, tobramycin and neomycin) and spectinomycin in feed at cross-contamination level, where an absolute lack of suitable methods was identified. Four candidate methods described in the literature failed to provide adequate recoveries of all analytes. Therefore, an in-depth investigation was carried out to identify the bottleneck variable. The optimised method was then in-house validated and showed performance features appropriate for the intended purpose. The selected compounds could be analysed by LC-MS/MS in five animal feeds with LOQs between 2.6 and 9.2 µg kg-1 for the AGs and between 28 and 86 µg kg-1 for spectinomycin. Using isotopically labelled internal standards, the recovery rates varied from 63 % to 103 % and the intermediate precision (RSDip) varied from 1.1 % to 14 %. This work represents a step forward in the reliable determination of antibiotics in compound feed as the developed method has shown to be precise and sensitive. It is expected that this method gains wide acceptance and can supplement the legislation with effective control tools for antibiotic residues.

Botanical Impurities in the Supply Chain: A New Allergenic Risk Exacerbated by Geopolitical Challenges.

BACKGROUND: The supply chains of food raw materials have recently been heavily influenced by geopolitical events. Products that came from, or transited through, areas currently in conflict are now preferentially supplied from alternative areas. These changes may entail risks for food safety. METHODS: We review the potential allergenicity of botanical impurities, specifically vegetable contaminants, with particular attention to the contamination of vegetable oils. We delve into the diverse types of botanical impurities, their sources, and the associated allergenic potential. Our analysis encompasses an evaluation of the regulatory framework governing botanical impurities in food labeling. RESULTS: Unintended plant-derived contaminants may manifest in raw materials during various stages of food production, processing, or storage, posing a risk of allergic reactions for individuals with established food allergies. Issues may arise from natural occurrence, cross-contamination in the supply chain, and contamination at during production. The food and food service industries are responsible for providing and preparing foods that are safe for people with food allergies: we address the challenges inherent in risk assessment of botanical impurities. CONCLUSIONS: The presence of botanical impurities emerges as a significant risk factor for food allergies in the 2020s. We advocate for regulatory authorities to fortify labeling requirements and develop robust risk assessment tools. These measures are necessary to enhance consumer awareness regarding the potential risks posed by these contaminants.

Re-Evaluating Cross-Contamination: Additional Trials on Co-Ventilation.

BACKGROUND: Medical equipment can become scarce in disaster scenarios. Prior work has reported that four sheep could be ventilated together on a single ventilator. Others found that this maneuver is possible when needed, but no one has yet investigated whether cross-contamination occurs in co-ventilated individuals. OBJECTIVE: Our goal was to investigate whether an infection could spread between co-ventilated individuals. METHODS: Four 2-L anesthesia bags were connected to a sterilized ventilator circuit that used heat and moisture exchange filters and bacterial and viral filters, as would be expected in this dire scenario. Serratia marcescens was inoculated into "lung" no. 1. After running for 24 h, each lung and three additional points in the circuit were cultured to see whether S. marcescens had spread. These cultures were examined at 24 and 48 h to assess for cross-contamination. This entire procedure was performed three times. RESULTS: S. marcescens was not found in lung no. 2, 3, or 4 or the three additional sites on the expiratory limb at 24 and 48 h in all three trials. CONCLUSIONS: Cross-contamination does not occur within 24 h using the described ventilator circuit configuration.

Poultry Food Assess Risk Model for Salmonella and Chicken Gizzards: III. Dose Consumed Step.

The Dose Consumed step of the Poultry Food Assess Risk Model (PFARM) for Salmonella and chicken gizzards was presented and compared to the Exposure Assessment step of Quantitative Microbial Risk Assessment (QMRA). The specific objectives were 1) to demonstrate the dose consumed step of PFARM for Salmonella and chicken gizzards; 2) to compare Salmonella dose consumed from cooked chicken gizzards to that from cross-contaminated and temperature-abused lettuce; 3) to determine if Salmonella dose consumed changed over time in a production chain; and 4) to compare PFARM and QMRA predictions of Salmonella dose consumed. The PFARM and QMRA were developed in an Excel notebook and simulated with @Risk. Salmonella prevalence and number data (P = 100) for chicken gizzards (56 g) and scenario analysis were used to address objectives 1, 2, and 4, whereas running windows of 60 consecutive chicken gizzard samples and scenario analysis were used to address objective 3. A lot size of 1,000 kg of chicken gizzards was simulated. Mean portion size was 168 g resulting in the simulation of 5,952 meals per lot. Of these, 3.69 ± 0.32% and 0.49 ± 0.07% (mean ± SD) resulted in Salmonella dose consumed of ≥1 per meal from cooked chicken gizzards and lettuce, respectively. However, the total Salmonella dose consumed per lot from cooked chicken gizzards (272 ± 27) was less (P ≤ 0.05) than from lettuce (6,050 ± 4,929) because of a few highly contaminated (>310 Salmonella) lettuce portions at consumption. Over time in the production chain, Salmonella prevalence and total dose consumed per lot changed (P ≤ 0.05) but the patterns differed. The QMRA predicted higher (P ≤ 0.05) Salmonella dose consumed per meal than PFARM. In part, this was because QMRA only simulated contaminated grams, whereas PFARM simulated contaminated and non-contaminated meals. However, other factors, which are discussed, also contributed to the overestimation of Salmonella dose consumed by QMRA.

Human intestinal enteroids and predictive models validate the operational limits of sanitizers used for viral disinfection of vegetable process wash water.

Vegetables are globally associated with a considerable number of foodborne outbreaks caused by viral infections, specifically human norovirus. In fresh produce industry, washing represents a critical step for food safety as process wash water (PWW) needs to be maintained at appropriate microbial quality to prevent water-mediated cross-contamination. This study aimed to explore the disinfection efficacy of chlorine (free chlorine, FC), chlorine dioxide (ClO2) and peracetic acid (PAA) in PWW against infectious human norovirus and Tulane virus (TV). First, we tested the extent of TV inactivation in baby leaf, bell pepper, and vegetables mix PWW and monitored the viral decay by cell culture. Then, inactivation kinetics were defined for infectious human norovirus exposed to FC, ClO2 and PAA in baby leaves PWW using the human intestinal enteroids (HIE) system. Finally, kinetic inactivation models were fitted to TV reduction and decay of sanitizers to aid the implementation of disinfection strategies. Results showed that >8 log10 human norovirus and 3.9 log10 TV were inactivated by 20 ppm FC within 1 min; and by 3 ppm ClO2 in 1 min (TV) or 5 min (norovirus). PAA treatment at 80 ppm reduced ca. 2 log10 TV but not completely inactivated the virus even after 20 min exposure, while 5 min treatment prevented norovirus replication in HIE. TV inactivation in PWWs was described using an exponential decay model. Taking these data together, we demonstrated the value of applying the HIE model to validate current operational limits for the most commonly used sanitizers. The inactivation kinetics for human norovirus and TV, along with the predictive model described in this study expand the current knowledge to implement post-harvest produce safety procedures in industry settings.