End Of Shelf Life Research Articles

Analysis of Transfusion-Transmitted Bacterial Infections according to German Hemovigilance Data (2011–2020)

Introduction: Following the first assessment of the effects of safety measures taken against transfusion-transmitted bacterial infections (TTBI), the Paul-Ehrlich-Institut (PEI) decided to newly analyze risk minimization measures (RMM) using German hemovigilance data from 2011 to 2020, focusing on blood components, recipients, and bacterial strains. Materials and Methods: The PEI assessed the imputability of all reported serious adverse reactions (SAR) relying mainly on microbiological test results. Reporting rates (RR) of suspected, confirmed, and fatal confirmed TTBI were calculated and compared to the previous reporting 10-year period (2001–2010) using Poisson regression to estimate RR ratios (RRR). Furthermore, details on blood component age, patients’ medical history, and bacterial pathogenicity were collected. Results: With respect to the previous 10-year period, the number of suspected TTBI increased (n = 403), while fewer cases were confirmed (n = 40); the number of deaths remained more or less unchanged (n = 8). The RR for suspected TTBI were 7.9, 18.7, and 1.6 cases per million units transfused for red blood cells (RBC), platelet concentrates (PC), and fresh frozen plasma (FFP), respectively. RRR showed a statistically significant 2.5-fold increase in the RR for suspected TTBI after RBC administration from 2001–2010 to the period under review (p < 0.0001). The RR for confirmed TTBI were 0.4, 5.0, and 0.0 cases per million units transfused for RBC, PC, and FFP, respectively. Compared to the period 2001–2010, there was a statistically significant decrease in the RR of confirmed TTBI by half for PC (p = 0.0052). The RR for confirmed PC-caused TTBI with fatal outcome was 1.4 cases per million units transfused. Regardless of type of blood product transfused and outcome of SAR, the majority of TTBI occurred after administration of a product at the end of shelf life (40.0%) and to recipients of advanced age (median age: 68.5 years) and/or with severe immunosuppression (72.5%) due to decreased myelopoiesis (62.5%). 72.5% of the involved bacteria had a middle/high human pathogenicity. Conclusion: Despite a significant decrease in confirmed TTBI following PC transfusion in Germany after implementation of RMM, the current manufacture of blood products can still not prevent TTBI with fatal outcomes. As demonstrated in various countries, RMM like bacterial screening or pathogen reduction may measurably improve the safety of blood transfusion.

Microbiota profile of filleted gilthead seabream (Sparus aurata) during storage at various conditions by 16S rRNA metabarcoding analysis

The aim of the present work was to study the microbiota profile of gilthead seabream (Sparus aurata) fillets stored either aerobically or under Modified Atmosphere Packaging (MAP) conditions at 0, 4, 8 and 12 °C, via 16S rRNA metabarcoding sequencing. Throughout storage, sensory assessment was also applied to estimate fillets’ end of shelf-life. Results indicated that storage conditions strongly influenced the shelf-life of the fillets, since the sensorial attributes of air-stored samples deteriorated earlier than that of MAP-stored fillets, while higher temperatures also contributed to a more rapid products’ end of shelf-life. Metataxonomic analysis indicated that Pseudomonas was by far the dominant genus at the end of fillet’s shelf-life, in the vast majority of treatments, even though a sporadic but noteworthy presence of other genera (e.g, Shewanella, Carnobacterium, Brochothrix etc.) at the middle stages of MAP-stored fillets is also worth mentioning. On the other hand, a completely different profile as well as a more abundant bacterial diversity was observed at the end of shelf-life of MAP-stored fillets at 12 °C, in which Serratia was the most dominant bacterium, followed by Kluyvera, Hafnia, Rahnella and Raoultella, while Pseudomonas was detected in traces. The findings of the present work are very important, providing useful information about the spoilage status of gilthead seabream fillets during several storage conditions, triggering in parallel the need for further studies to enrich the current knowledge and help stakeholders develop innovative strategies that delay the growth of key spoiler players and consequently, retard spoilage course.

Survival of Naturally Contaminating Listeria monocytogenes in Commercial Mediterranean-Style Dry Fermented Sausages during Storage

The aim of the present study was the determination of Listeria monocytogenes, competitive microbiota, microbial hygiene indicators, and physicochemical parameters in the typical Mediterranean-style fermented sausages Salsiccia Sarda. A batch of Salsiccia Sarda (25 samples) naturally contaminated by L. monocytogenes and vacuum packaged after 24 days of ripening was included in the study. Fifteen samples stored at 8°C were analyzed after 13 days, after 90 days, and at the end of shelf life (after 180 days from vacuum packaging). Ten vacuum-packaged samples were stored at 12°C in a domestic fridge simulating temperature abuse and were evaluated at the end of the shelf life. Samples were subjected to physicochemical analysis (pH and water activity) and investigated for the presence and enumeration of L. monocytogenes. Competitive microbiota, lactic acid bacteria, coagulase-negative staphylococci, and microbial hygiene indicators (total mesophilic bacterial counts, Enterobacteriaceae, Enterococcuss spp., and Staphylococcus aureus) were determined in all the samples. Although a decreasing trend in L. monocytogenes prevalence was observed through the shelf life, the detection of this pathogen in fermented sausages confirms its ability to overcome hurdles of the manufacturing process. The results highlight the importance of the careful evaluation of the Salsiccia Sarda production process by food business operators to maintain unfavorable conditions for the growth of L. monocytogenes.

Effect of CoolBot cold storage and modified atmosphere packaging on the shelf life and postharvest quality of collards

Collard (Brassica oleracea var.acephala L.) is a nutritious leafy vegetable that is widely cultivated and consumed in Kenya. However, collard is highly perishable with a shelf life of one to two days at ambient conditions, which limits its consumption. Exploring storage options and packaging methods that can extend the shelf life of collards, can avert quantity and quality losses of the vegetable. This will ensure sustained income to producers and continued vegetable supply to consumers. The study aimed to evaluate the effectiveness of CoolBotTM Technology and Modified Atmosphere Packaging (MAP) as options to preserve quality and extend the shelf life of collards. Two experiments were conducted at Kabete and Juja sub-counties using freshly harvested collards from the University of Nairobi Kabete farm. In each experiment, homogenous batch of freshly harvested collards were first divided into four batches. The vegetable batches were then subjected to two storage options (CoolBotTM cold room; 5±2 °C, 75±20% RH, and ambient conditions; 25±10 °C, 50±15% RH), which were further split into two packaging treatments (packaged using Xtend® MAP, and unpackaged). The experimental layout was a 2 by 2 factorial arranged in a completely randomized design with three replications. Measurements were performed daily to determine cumulative weight loss, yellowing, wilting and color changes. Biochemical assay was also performed to determine the changes in vitamin C and beta-carotene content. Results show that CoolBotTM cold storage extended the shelf life of collards by 6 days without MAP and 13 days with MAP, in comparison to collards stored at ambient conditions. The slow rate of deterioration under CoolBotTM storage (with or without MAP) was evidenced by delayed yellowing, wilting, and reduced weight loss compared to ambient conditions, in the two experimental sites. The loss in vitamin C content was significantly higher (p ≤ 0.05) in collards under ambient conditions than those under CoolBotTM storage. In ambient conditions, unpackaged collards lost 77.7% of their vitamin C content while the packaged collards lost 57.7% by end of shelf life (day four). In CoolBotTM storage, packaged collards lost 18.4% whereas the unpackaged lost 26.3% of their initial vitamin C content. In CoolBotTM storage, packaged collards lost 26.2% while the unpackaged lost 44.1% of their initial Vitamin C by day seven. These results demonstrate a synergistic effect of CoolBotTM cold storage and MAP in preserving quality and extending the shelf life of collards. Key words: CoolBot Technology, Xtend, Collards, Postharvest Quality, Shelf life

Employment of cold atmospheric plasma in chilled chicken breasts and the analysis of microbial diversity after the shelf-life storage

Cold atmospheric plasma, featured as a non-thermal food processing technology has gained prominent attention for its practical application. The demand for chilled chicken has increased rapidly due to its nutritious value. However, chilled chicken often suffers from a short shelf life due to its susceptibility to spoilage. In this study, air- and nitrogen plasma were applied to investigate microbial inactivation effects and shelf-life extension of chilled chicken. Meanwhile, the microbial diversity of chicken breasts after air and nitrogen-CAP treatment and at the end of shelf-life was analyzed. Results illustrated that the inactivation effects of air plasma were more potent than that of nitrogen plasma, while nitrogen plasma could better maintain the sensory properties. Also, further investigation illustrated that air- and nitrogen-CAP could change the microbial community significantly. Both treatment time and working gases were essential experimental parameters that affected the microbial community composition.

Shelf-life studies of putative probiotic Lacticaseibacillus casei strains in milk and model yogurt.

Lacticaseibacillus casei are commonly utilized as probiotic in a wide-range of fermented and unfermented dairy products. The stability of probiotics in fermented dairy products during shelf-life is of concern due to low pH and high level of organic acids. The objective of this study is to evaluate L. casei for their ability to survive in a model yogurt and fluid milk; additionally, their impact on the pH, organic acids, and sensory attributes of these products was examined. The strain-to-strain differences in cell densities in yogurt and milk inoculated at a therapeutic level at the end of shelf-life were 1.2 and 1.4 log CFU/mL, respectively. Five of the strains examined increased the pH of the yogurt, while two strains were observed to reduce the pH. In milk, one strain raised the pH, while eleven strains reduced the pH. The levels of lactate, acetate, and formate in both the yogurt and milk were altered in a strain-specific manner. The results suggested that the metabolism by these strains differed significantly during the shelf-life. Careful strain selection is required to identify probiotic L. casei strains that will survive through shelf-life in either yogurt or fluid milk and not impact product quality.

TOPINAMBOUR MAIN COMPONENTS CONTENT DETERMINATION IN THE PROCESS OF STORAGE VIA ANALYTICAL AND PHYSICOCHEMICAL ANALYSIS METHODS

Paper is devoted to the study of topinambour's biologically active substances through analytical and physico-chemical analysis methods.&#x0D; In the course of experiment, content of inulin and vitamins in topinambour was determined, using methods of analytical chemistry, which was: inulin – 65,43 μg/100 g, vitamin C – 100,12 μg/100 g, beta-carotene – 55,26 μg/100 g.&#x0D; Change in inulin mass fraction in topinambour's raw material powder during its storage at different temperatures was investigated. During seven months topinambour tubers storing at different temperature conditions, the mass fraction of inulin was larger in altered into powder and dried raw materials - 60 %, then in freezer – 50 % and the smallest mass fraction was in refrigerator – 20 %.&#x0D; Сhange in ascorbic acid mass fraction by means of titrimetric analysis method was investigated. A sharp decrease of ascorbic acid content in tuber's powder was observed, it is due to vitamin inactivation under high temperatures in the process of raw materials drying. Content of ascorbic acid in cooled tubers (4 ± 2) °С to the end of shelf-life decreased by 60 %. The best results were obtained in frozen tubers (–20 ± 2) °C, content of ascorbic acid in them has changed 12–15 % compared to control sample.&#x0D; Beta-carotene content was determined by photocolorimetric method according to standard methods. Content of β-carotene decreased to a level 12 % by the end of shelf life in topinambour's tuber powder. In frozen tubers (–20 ± 2) °С content of β-carotene was accompanied by a decrease in the mass fraction of β-carotene throughout whole storage period and amounted to 60 %. The best results were obtained in tubers that overwintered in soil, vitamin's mass fraction in them decreased by only 10 %.&#x0D; When storing topinambour's tubers at different temperature conditions, proportion of vitamins is the highest in tubers that have overwintered in soil, then in the freezer and the lowest in the refrigerator.&#x0D; Recommendations on the method of topinambour's storage with maximum preservation of biologically active substances content were given. &#x0D; Dried topinambour's tuber powder is most suitable for long-term storage with minimal loss of inulin and beta-carotene, which allows to use this powder in the production of therapeutic and prophylactic drugs. &#x0D; When stored at temperatures (–20 ± 2) °C there is a sharp decrease in nutrients in the first two months and a further decrease is very slow. Such storage is expedient if it is necessary to keep tubers for a long time. For example, in production of topinambour's preparations it is necessary to provide а plant with raw materials for the winter. &#x0D; Storage in refrigerator at a temperature of (4 ± 2) °C is advisable for a short period of time. Decrease of inulin and vitamins content is not rapid, in such conditions it can be stored for two months. In the long period, tubers wither and pathogenic microflora begins to develop on them.&#x0D; The best indicators in all biologically active substances were stored in tubers that overwintered in the soil. Because the top layer in topinambour does not protect cells from decay processes, these processes are activated during digging, and tubers, that were left in the soil, continue to functionate, so cell apoptosis is not activated.

Shrimp (Penaeus monodon) preservation by using chitosan and tea polyphenol coating combined with high-pressure processing.

The present work investigated the effects of high‐pressure processing (200 and 400 MPa, 5 min) combined with chitosan‐tea polyphenol (1.5% and 0.5% [w/v], respectively) coating to improve the quality and stability of shrimp (Penaeus monodon) during 28 days of storage. The chemical (pH, TVB‐N, TBARS), microbiological, textural, chromatic characteristics, protein oxidation, and endogenous enzyme activities of shrimps were regularly evaluated. Results showed that the combination treatment exerted a better intense antimicrobial effect, stabilized shrimp's freshness, and resulted in lower pH and TVB‐N than the control sample. Also, combined treated samples had better oxidative stability than a single treatment until the end of shelf life. Although combination treatment had no significant effect on endogenous proteases, the combined use of 400 MPa high‐pressure and chitosan‐tea polyphenol coating was most effective in inhibiting the bacteria and improved the hardness and chromatic characteristics of shrimp within the storage.

Clinically proven specification setting for a meningococcal serogroup a conjugate vaccine

GSK is currently working to improve the commercial presentation of the licensed quadrivalent conjugate vaccine (Menveo) for use against meningococcal serogroup A, C, W, Y (MenACWY) infections. Menveo consists of a primary, lyophilized vial, containing the serogroup A antigen that is reconstituted with the content of a second, liquid, vial that contains the serogroup C, W, Y antigens, to give the final liquid MenACWY product.Since the MenA structure is prone to hydrolytic degradation in liquid formulations, we used mathematical models to rationally design a clinical Phase 2 development plan and provide end of shelf-life (EoSL) and release specification setting for the MenACWY liquid product.By using development and clinical stability data, statistical models were built and used to predict both the MenA free saccharide (FS) and O-Acetyl (OAc) content during long-term storage conditions at 5 °C and stressed (accelerated) stability studies at 15 °C, 22.5 °C, 25 °C, 37 °C and 50 °C. This approach allowed us to define an aging plan for the clinical material to reach at least the required levels of MenA FS and OAc levels at product EoSL. The clinical material was then exposed to a temperature of 22.5 ± 2.5 °C for 59 days to generate FS OAc content of about 35% and 40%, respectively, which was then delivered to the patients in the clinical trial.To the best of our knowledge, this work represents the first example in the field of vaccine research where statistical models have been used to rationally design tailored lots, with the goal of setting EoSL and release specification limits based on data collected on artificially aged clinical material, in which the FS and OAc levels tested were intended to support a product shelf-life of at least 24 months.

INVESTIGATION OF FLAVOUR PERMANENCE OF STRAWBERRY AND WATERMELON FLAVOURED CHEWING GUMS BY USING RETRONASAL AROMA TRAPPING DEVICE AND SENSORY ANALYSIS TECHNIQUES

Combining in vivo instrumental analysis with sensory evaluation techniques to analyze the release of volatile components from the gum matrix is gaining importance due to the flavour expectations of consumers. Besides consumers’ preferences and quality of flavourings determine the market value of chewing gums. In this study, strawberry and watermelon flavoured chewing gums were prepared and evaluated with both sensory evaluation and analytical techniques by using retronasal aroma trapping device and dynamic headspace analysis - DHA-GC/MS. Ethyl hexanoate and isoamyl acetate were chosen as flavour compounds for strawberry and watermelon flavoured gums to monitor in the study. The in vivo experiment with retronasal aroma trapping device showed that selected compounds were quite intense in the first 5 min of breath, and they were also detected in the 45th min of chewing. The flavour stability of the chewing gums was also monitored for 3 months. According to all sensory and instrumental analyzes, watermelon flavour was perceived as watermelon taste both at the 45th min and at the end of shelf life (equal to 12 months).

Use of a silver-based sanitizer to accelerate Escherichia coli die-off on fresh-cut lettuce and maintain produce quality during cold storage: Laboratory and pilot-plant scale tests

Outbreaks and product recalls involving romaine and iceberg lettuce are frequently reported in the United States. Novel technologies are needed to inactivate pathogens without compromising product quality and shelf life. In this study, the effects of a process aid composed of silver dihydrogen citrate, glycerin, and lactic acid (SGL) on Escherichia coli and Listeria monocytogenes concentrations on lettuce immediately after washing and during cold storage were evaluated. Sensory and quality attributes of fresh-cut iceberg lettuce were also evaluated. Laboratory results indicated that application of SGL solution for 30 s as a first step in the washing process resulted in a 3.15 log reduction in E. coli O157:H7 immediately after washing. For E. coli O157:H7 a significant difference between SGL treatment and all other treatments was maintained until day 7. On day zero, SGL led to a 2.94 log reduction of L. monocytogenes. However, there was no significant difference between treatments with or without SGL regardless of storage time. Pilot-plant results showed that samples receiving SGL spray followed by chlorinated flume wash exhibited a greater reduction (1.48 log) in nonpathogenic E. coli populations at the end of shelf life than other treatments (p < 0.05). Additional pilot plant tests were conducted to investigate the hypothesis that SGL residues could continue to impact microbial survival on the final washed lettuce. Results show that pathogens introduced subsequent to flume washing of lettuce pretreated with SGL solution were not affected by antimicrobial residues. The final quality and shelf life of flume washed lettuce were also unaffected by pretreatment with SGL. In conclusion, the results of this study demonstrate that this new technology has the potential to accelerate E. coli die-off on fresh-cut lettuce during cold storage and improve product safety, while not affecting quality throughout the shelf life of the finished products.

Volatile compositions of strawberry fruit during shelf life using pre and postharvest hexanal treatment

Changes in volatile compositions were determined in Rubygem strawberry variety related to pre and postharvest hexanal application during shelf life. For this concern, Rubygem variety was treated with hexanal vapor and spray applications which were, doses (0%, 0.01%, 0.02%) pre and postharvest after hexanal applications strawberry fruits were stored at 2°C and RH 90% conditions. Effects of hexanal spray and vapor applications of strawberry fruit volatile profiles were analyzed with HS-SPME/GC–MS techniques. Differences among treatments were identified in volatile compositions at 3 days intervals during 15 days of shelf life. The results showed that, hexanal application type and concentration effected the percentage of volatile composition of esters, ketones, terpens, alcohols, acids, aldehydes, and others during shelf life. The hexanal application form and concentration were effected the amount and composition of volatiles of Rubygem strawberry fruit. As a result, hexanal spray application has important effects on ester percentage, however, hexanal vapor treatment increased the alcohols percentage of strawberries at the end of shelf life. Practical applications Application of organic substances of hexanal pre and postharvest season has been successfully used due to their environmentally friendly effects. Hexanal is volatile gases, organic aldehydes which are the source of plant extract and used as food additives. There are many research on hexanal application to prevent microbial growth after harvest. In the present study, hexanal spray and vapor applications were used to determined the volatiles profile strawberries fruit during shelf life.

Comparative studies on the correlation of Campylobacter spp. at different stages in the broiler production chain

Knowing the Campylobacter spp. load at each stage of production can be helpful in selecting appropriate control methods. The aim of the present study was therefore to evaluate the quantitative contamination of broilers with Campylobacter spp. at different levels of production (pre-harvest, harvest, and post-harvest) by using the culture method, and to identify the types of samples that can accurately predict the contamination level of the meat. For this purpose, broilers from two different processors were examined. The data were statistically modeled to describe the Campylobacter spp. counts in the samples and to identify correlations between counts in the different sample types, including fecal samples before slaughtering, cecal content at slaughter, neck skin after chilling, cut meat pieces, and finally meat cuts at the end of shelf-life. The Campylobacter spp. counts in pooled fecal samples at pre-harvest level were generally lower than those in individual cecal samples after slaughtering. The results of the meat samples at slaughter level showed that skinless breast fillet samples were less contaminated than legs with skin and neck skin after chilling. The examination of samples at the end of shelf-life showed that breast fillets and legs had lower Campylobacter spp. counts compared to the samples at the beginning of the storage. From these results, it can be summarized that a simple calculation of Campylobacter spp. counts from fecal samples collected on the farm did not allow a direct prediction of Campylobacter spp. loads in cecal content or neck samples. The cecal samples on the other hand can be appropriate to predict Campylobacter spp. counts in neck skin and breast fillet samples.

Noninferior Red Cell Concentrate Quality after Repeated Air Rescue Mission Transport for Prehospital Transfusion

Background: Transfusion of red cell concentrates (RCCs) is an integral therapy after severe hemorrhage or trauma. Prehospital transfusion offers an immediate intervention in emergency cases. Air ambulance-based prehospital transfusion, already used in different countries, is currently established in Germany. Limited information is available for regulatory-compliant transport logistics of RCCs and their quality after repeated air rescue missions. Thus, the aim of this study was (i) to validate regulatory-compliant logistics and (ii) to assess product quality, analyzing biochemical parameters and RBC morphology. Study Design and Methods: Due to regulatory requirements, we adapted a rotation system of 1 day transport, 1 day quarantine storage and 1 day storage over the entire RCC shelf life. RCCs transported on air rescue missions (flight group) were compared against a control group, treated identically except for helicopter transport. RCCs were visually inspected, and their temperature was documented throughout the entire rotation cycles. RCCs at the end of shelf life (end point samples) were assessed for levels of hemoglobin, hematocrit, free hemoglobin, hemolysis, mean corpuscular volume, potassium and pH. In addition, morphological changes were assessed using flow morphometry. Results: In total 81 RCCs were assessed in the flight group and 50 in the control group. Within the flight group, 30 RCCs were transfused. RCCs were dispatched on average 11 times (7–13 times). The average flight time was 18.3 h (6.6–28.8 h). The rotation system ensured adherence to regulatory guidelines, especially compliance to storage conditions of +2 to +6°C of intermediate storage. Biochemical and morphological quality parameters did not exhibit any changes upon repeated air rescue missions. A correlation with respect to the flight time was not observed either. Discussion: The quality of RCCs after repeated air rescue missions is noninferior to control samples regarding biochemical and morphological parameters. The product quality is within German regulations for up to 42 days of storage. The logistics and maintenance of the thermal conditions are safe and feasible. Thus, a rotation system of RCCs offers a regulatory-compliant option to supply air rescue missions with RCCs to allow life-saving prehospital transfusions at the incident scene.

Effect of Different Coloured Plastics and Liners on Shelf Life of Loose Marigold Flowers

A study was carried to evaluate the effect of different coloured plastics and liners on shelf-life of loose marigold flower under ambient condition was at the laboratory of the Department of Floriculture and Landscape Architecture, College of Agriculture, Indira Gandhi Krishi Vishwavidyalaya, Raipur, during the year 2021–2022. The experiment was laid out in Complete Randomized Design with 3 replication and 16 treatments. The treatment comprised of different coloured plastics (Red, Opaque, Transparent and Green) and liners (Paper cutting, Paper straw and Bubble film) in different combination including control. The results revealed that among all the combination of different coloured plastics and different liners used treatment T7 (Transparent + Paddy straw) showed better quality in all parameters like physiological weight loss(2.26%, 34.20% and 47.10%), moisture content(82.33%,71.72% and55.01%), spoilage percentage(5.10%,12.37% and 25.19%), diameter of flower (5.81cm, 5.09cmand 4.40 cm), freshness index(4.68, 3.98 and 3.11 out of 5 score card), relative water content(83.00%,74.00% and 55.66%), shelf life(2.35 days) at 2nd, 4th and 6th days after storage respectively. When the spoilage of flower exceeded 50 percent, it was considered as the end of shelf life or storage life.

Compositional characteristics of dairy products and their potential nondairy applications after shelf-life

Many dairy products are discarded and useless after end of shelf-life, which causes economic and environmental challenges. The objective of this study was to study the compositional characteristics of some dairy products before and after shelf-life, and develop a process to utilize those dairy products after end of shelf-life in non dairy applications (cosmetic cream and soap). Several dairy products, such as sterilized milk, yogurt, soft cheese, hard cheese, cream, and butter were collected from markets in Egypt before shelf-life and after three months of shelf-life. Electrophoresis analysis was conducted to estimate the changes in the protein fractions of protein products (sterilized milk, yogurt, and cheese) before and after expiration. Also, gas chromatography (GS) was performed to compare the fatty acids of fat products (cream and butter) before and after end of shelf-life. Sterilized milk, yogurt, soft, and hard cheese were turned into powder (Expired dairy products powder; EDPP) to be used as a raw material in manufacturing of cosmetic creams. The fat was separated from cream, butter, and hard cheese (Expired dairy products fat; EDPF) to be utilized in making soap. The formulated cosmetic creams were examined in vitro. Functional properties of cream were determined, such as appearance, spreadability, irritancy, and pH. Additionally, the soap quality was tested after manufacture. We found that dairy products, such as milk, yogurt, and cheese after shelf-life can be utilized as raw materials for the production of cosmetic creams, as well as production of soap from butter and cream. The produced products were similar to those in commercial markets. This study is an endeavor to conquer the dairy industry challenges, which are considered a huge loss from the economic and environmental aspects.

Spoilage Investigation of Chill Stored Meagre (Argyrosomus regius) Using Modern Microbiological and Analytical Techniques.

Spoilage status of whole and filleted chill-stored meagre caught in January and July was evaluated using sensory, microbiological, 16S metabarcoding and Volatile Organic Compounds (VOCs) analysis. Based on the sensory analysis, shelf-life was 15 and 12 days for the whole fish taken in January and July, respectively, while 7 days for fish fillets of both months. For the whole fish, Total Viable Counts (TVC) at the beginning of storage was 2.90 and 4.73 log cfu/g for fish caught in January and July respectively, while it was found about 3 log cfu/g in fish fillets of both months. The 16S metabarcoding analysis showed different profiles between the two seasons throughout the storage. Pseudomonas (47%) and Psychrobacter (42.5%) dominated in whole meagre of January, while Pseudomonas (66.6%) and Shewanella (10.5%) dominated in fish of July, at the end of shelf-life. Regarding the fillets, Pseudomonas clearly dominated at the end of shelf-life for both months. The volatile profile of meagre was predominated by alcohols and carbonyl compounds. After univariate and multivariate testing, we observed one group of compounds (trimethylamine, 3-methylbutanoic acid, 3-methyl-1-butanol) positively correlating with time of storage and another group with a declining trend (such as heptanal and octanal). Furthermore, the volatile profile seemed to be affected by the fish culturing season. Our findings provide insights into the spoilage mechanism and give information that helps stakeholders to supply meagre products of a high-quality level in national and international commerce.

Randomized, double-blind, two-way crossover bioequivalence and adhesion study, in healthy women, of a transdermal contraceptive patch with a newly sourced adhesive component at the end of shelf life vs. the EVRA patch at the beginning of shelf life.

Objective: Evaluate bioequivalence, based on norelgestromin (NGMN) and ethinyl estradiol (EE) plasma concentrations, and adhesion of a transdermal contraceptive patch containing a newly sourced adhesive component (test) at end of shelf life (EOSL) vs. the marketed EVRA patch (reference) at beginning of shelf life (BOSL). Materials and methods: In this randomized, double-blind, two-way crossover study, healthy women received a single, 7-day application of test and reference patches in 4 sequences: two 11-day treatment periods separated by a 21-day washout. Assessments included NGMN and EE pharmacokinetics (PK), adhesion (per European Medicines Agency (EMA) 5-point scale), irritation potential and application-site reactions, and tolerability. Patches were bioequivalent if 90% CIs of geometric mean ratios (GMRs) of test/reference for Cmax, AUC168h, AUC0–tlast, and AUC∞ were 80 – 125%. Patch adhesion was comparable if ratios of geometric mean cumulative adhesion percentages were ≥ 90%. Results: 68 women were randomized, and 62 completed both treatments. 55 and 59 participants in the reference and test group, respectively, had patch adhesion ≥ 80% (EMA score 0 – 1) at end of treatment. Bioequivalence was demonstrated: GMRs for pharmacokinetic (PK) parameters ranged from 102.76 to 105.57% for NGMN and 93.78 – 94.80% for EE, and associated 90% CIs were fully within the bioequivalence acceptance range (80 – 125%) for both. The patches had comparable adhesion properties (GMR, 101.4% (90% CI: 99.2 – 103.6)) and incidences of treatment-emergent adverse events. Conclusion: NGMN-EE transdermal test patch at EOSL was bioequivalent to the marketed patch at BOSL, supporting widening the product’s shelf-life specification. Adhesive properties and safety profiles were comparable between patches.

Tracing Antibiotic Resistance Genes along the Irrigation Water Chain to Chive: Does Tap or Surface Water Make a Difference?

Irrigation water is well known as potential source of pathogens in fresh produce. However, its role in transferring antibiotic resistance determinants is less well investigated. Therefore, we analyzed the contribution of surface and tap water to the resistome of overhead-irrigated chive plants. Field-grown chive was irrigated with either surface water (R-system) or tap water (D-system), from planting to harvest. Water along the two irrigation chains as well as the respective plants were repeatedly sampled and screened for 264 antibiotic resistance genes (ARGs) and mobile genetic elements (MGEs), using high-capacity qPCR. Differentially abundant (DA) ARGs were determined by comparing the two systems. On R-chive, β-lactam ARGs, multidrug-resistance (MDR) determinants, and MGEs were most abundant, while D-chive featured DA ARGs from the vancomycin class. Diversity and number of DA ARGs was the highest on young chives, strongly diminished at harvest, and increased again at the end of shelf life. Most ARGs highly enriched on R- compared to D-chive were also enriched in R- compared to D-sprinkler water, indicating that water played a major role in ARG enrichment. Of note, blaKPC was detected at high levels in surface water and chive. We conclude that water quality significantly affects the resistome of the irrigated produce.

Potential Mitigation of the Covert Risk of Bacterial Contamination of RBC: Inactivation of Propionibacterium Acnes in RBC Using Amustaline and Glutathione

Background: Propionibacterium acnes is usually considered a commensal anaerobic non-pathogenic bacterium, which, originating from skin flora, is often found responsible for blood product contamination, including RBC. Various levels of risk are assigned to the different pathogens in RBC, with the bacterial risk of sepsis estimated to 1 in 2 million based on reported cases (Kleinman & Stassinopoulos, Transfusion 2015). RBC bacterial contamination is not assessed in routine practice and refrigerated storage is often given as the explanation for the lack of reported cases. In a recent study from the Canadian Blood Services (Kumaran D. et al ., Vox Sanguinis, 2017, 112(suppl),73) P. acnes was implicated in a severe transfusion reaction of a 59-year old patient suffering from acute leukemia. The patient recovered after antibiotic treatment, however this incident highlighted the risk associated with the transfusion of RBC components that are usually not tested for bacterial contamination. The same and related Propionibacterium- species were found to be contaminating 9/19 RBC components tested at outdate after day 43 of storage. Currently, only platelet components are routinely screened for the presence of bacteria in countries where bacterial culture screening has been adopted.A system for the broad spectrum inactivation of pathogens in RBCs is under development using the nucleic acid targeting technology that employs amustaline (S-303) and glutathione (GSH). The RBC recovery of the S-303/GSH treated RBC has been found to meet the FDA criteria and robust inactivation of various pathogens has been demonstrated, including emerging and established pathogens. Inactivation of bacteria by the system continues to be investigated.Methods and Results: In this study we used P. acnes acquired from the California State Health Department Services, identified after a case of sepsis and characterized through sequencing and MIDI analysis (CDHS 00A-6608). A highly concentrated bacterial stock (8.8 log10/mL) was generated by propagation in thioglycolate medium. It was then diluted 1:100 to a final titer of 6.6 log/mL into an RBC pool of two matched units prepared in AS-1 , that was subsequently split into two identical RBC units. One unit remained untreated (Control), while the parallel unit (Test) was treated using S-303 and GSH for ~20 h before an “exchange” step consisting of centrifugation and resuspension of RBC in SAG-M additive solution. Samples were harvested at 3 h and 20 h post-exchange for the Test unit and at 3 h and 20 h post-incubation for the Control unit. Test samples were screened by quantitative plate culture under anaerobic condition, while the Control samples were serially diluted to countable concentrations before similar culture screening. While bacterial titers remained unchanged in the Control unit, no viable bacteria were detected in the Test unit post-treatment, indicating a >6.6 log10/mL inactivation.Conclusion: The results of this study show that the covert risk of bacterial contamination in RBC components could be addressed by the pathogen reduction technology using S-303/GSH, even when bacterial titers far exceed the ones expected in refrigerated RBC at the end of shelf life. DisclosuresLu:Cerus Corporation: Employment. Goldbeck:Cerus Corporation: Employment. McCormack:Cerus Corporation: Employment. Bringmann:Cerus Corporation: Employment. Stassinopoulos:Cerus Corporation: Employment.