Industry Guidelines Research Articles

Quantification of Sofosbuvir in Human Plasma: RP-HPLC Method Development and Validation

Sofosbuvir, a potential inhibitor of the nucleotide analog of hepatitis C virus (HCV) NS5B polymerase, is used to treat hepatitis C and marketed under brand name Sovaldi. This study was aimed to develop and validate a simple, sensitive and precise RP-HPLC method for the estimation of sofosbuvir in human blood plasma using quinine sulfate as internal standard (ISTD). Separation was achieved using Shimadzu-HPLC system equipped with Gracesmart RP-C 18 (250 mm � 4.6 mm, 5 �m) column eluted at a flow rate of 0.5 mL/min and detected at 260 nm. The mobile-phase composition was optimized to be ammonium formate (pH 3.0; 10 mM) and acetonitrile (67 : 33, % v/v). The retention times of sofosbuvir and quinine sulfate were found to be 13.60 and 8.39 min, respectively. The proposed method was linear over a range from 20 to 1200 ng/mL. Liquid–liquid extraction technique was applied for the extraction of drug and ISTD from human plasma using TBME – DCM (80 : 20, % v/v) mixture. The proposed method was validated as per bioanalytical method validation guidelines for industry.

El medio ambiente sostenible de la mano del desarrollo económico

El desarrollo económico de una nación está claramente determinado por un manejo efectivo de sus recursos para la producción, desarrollo y crecimiento y por lo tanto asociamos que el progreso de uno afecta el avance del otro.Las investigaciones científicas nos demuestran además, que el calentamiento global ha sido causado por el afán por las riquezas de las industrias, por lo que es perentorio que los gobiernos incluyan políticas de acción y preservación, claras y universales para cualquier nación, sin dejar de involucrarnos personalmente en nuestro accionar en materia de competitividad y consumismo. La República Dominicana con un desarrollo económico en continuo crecimiento, ha establecido dentro de sus políticas de desarrollo acciones que fomenten el consumo sostenible y que promuevan la conservación de nuestros recursos naturales asegurando de esta manera la continuidad de esta evolución y sobre todo estableciendo los lineamientos para que las nuevas industrias y la generación entrante, tengan un soporte estructural sostenido en todos los renglones que afectan el buen desarrollo de esta isla. Al menos en teoría, la Republica Dominicana está a la vanguardia de las tendencias globales con políticas públicas enfocadas al desarrollo sostenible. Para mencionar algunos casos recientes la constitución de 2010 incluye e incorpora premisas importantes para el tema ambiental, la creación del Consejo Nacional para el Cambio Climático y el Mecanismo de Desarrollo Limpio, la estrategia nacional de desarrollo 2030, la Ley de Bioseguridad 219-15 y la Ley de Biodiversidad 333-15, y algunos proyectos de Ley como Pagos por Servicios Ambientales y la Ley de Agua que actualmente cursan los estamentos legislativos dominicanos. Sin embargo, es pertinente que este desarrollo sostenible se alimente con una realidad que debemos incorporar, una perspectiva a largo plazo que apuntale al manejo de estos recursos y que enfatiza en la solidaridad hacia las actuales y futuras generaciones defendiendo la equidad intergeneracional.

Polish and German Industry Guidelines in the Scope of Preparation of Certified Translations in a Contrastive Approach ‒ Practical Implications for Drawing Certified Translations of Polish and German Court Judgments

Abstract In the paper, the author undertakes a contrasting comparison of Polish industry guidelines for the preparation of certified translations contained in the Sworn translator’s code with the following German guidelines: Richtlinien und Hinweise für die Anfertigung von Urkunden-übersetzungen and Empfehlungen für die Anfertigung bestätigter/ beglaubigter Übersetzungen. Next, the results of the above comparison are referred to the certified translation of Polish and German court judgments.

Application of functional safety to electrical power equipment and systems in process industries

In process industries, the application of functional safety in preventing major incidents is a well-established practice. The functional safety standard IEC 61511 (IEC, 2016) is applied to the safety instrumented system (SIS) protection layers to avoid the undesired events or reduce the likelihood of the events or impacts due to failures in the process, process equipment, or its control system including human interactions. However, there are risks of catastrophic incidents due to electrical equipment failures as well. Therefore, one should not underestimate the importance of the management, design, installation, operation, and maintenance of electrical power systems and protection devices. Regulatory authorities, in some countries, require the owners or operators to address the risks that arise from electrical equipment failure.The risk-based assessment, allocation of safety functions to protection devices, the establishment of integrity requirements, design, installation, operation, and maintenance of electrical protection devices must be managed like the protection layers for the process units. This paper focusses on the application of IEC 61511 to the protection of electrical equipment and systems, available industry guidelines, and the unique challenges in implementing the functional safety standards. The paper guides the electrical engineers with an example risk assessment, identification of protection device and its safety integrity level (SIL), verification of the reliability of the protection device and establishing a maintenance and operation program.

Enhancing the quality attributes of salad dressing by incorporating Gac aril as a biologically active ingredient

Abstract Gac aril (GA) contains a very high level of lycopene, giving it exceptional antioxidant properties. Based on the superior properties of GA, the aim of this work was to fortify salad dressings with the lycopene from GA and monitor their stability during storage. The salad dressings were produced by incorporating different amounts of GA (0% to 20%, g/100 g) in the formulations. An increase in GA content caused a marked increase in the soluble fibre, lycopene and total phenolic contents while the fat content and the caloric value decreased. The firmness and viscosity also decreased with increasing GA content. The sensory evaluation revealed that the GA could be added to salad dressings up to a level of 20% and still be accepted by the consumer. It was verified the GA antioxidant effect in the salad dressing compared to that in the sample without GA, as evidenced by the peroxide value (POV), thiobarbituric acid-reactive substances (TBARS), p-anisidine value (p-AV) and total oxidation value (Totox V). The protective effects were approximately 1.75, 2.58, 5.14 and 7.58 times higher than those in the control sample for the samples containing 5%, 10%, 15% and 20% GA, respectively. It was concluded that GA could be used as an alternative source of lycopene, polyphenol compounds and dietary fibre, to enrich salad dressings. This work could be used as a guideline for industry to develop high value-added salad dressings.

Understanding the Amino Acid Profile of Whey Protein Products

BACKGROUND: The South African dietary supplement market will undergo a period of transition within the next few years due to the establishment of the South African Health Products Regulatory Authority (SAHPRA), which has superseded the former Medicines Control Council (MCC). While regulatory steps are yet to be fully outlined, products such as whey protein, regarded as food, will be governed by the Department of Health R429 draft Regulations Relating to the Labelling and Advertising of Foods. The guideline provides for the minimum value of essential amino acids (plus cysteine and tyrosine) per gram of protein that products claiming to contain protein will be required to comply with. Determining the compliance levels of whey protein products currently available will assist in establishing the readiness of the dietary supplement industry for regulation, and provide an indication of the overall state of the industry.OBJECTIVES: To determine the amino acid profile of whey protein powder and compare analysed content to manufacturer stated content.To compare analysed amino acid content to the Department of Health R429 draft Regulations Relating to the Labelling and Advertising of Food template amino acid profile.METHOD: 15 of the best-selling whey protein products available in South Africa were selected for amino acid analysis. Tested amino acid content were compared to the label stated claim and the amino acid reference pattern, as stated in the Department of Health R429 draft Regulations Relating to the Labelling and Advertising of Foods.RESULTS: Sixty percent (60%) of products tested were non-compliant with the Department of Health R429 draft Regulations Relating to the Labelling and Advertising of Foods. Of the 15 products tested, 11 were manufactured in South Africa, with 8 being non-compliant to the guideline amino acid profile. Considerable variance was noted in the manufacturer stated and the tested amino acid content (ranging from 16–48% variance).CONCLUSION: Many of the whey protein products available in South Africa are not compliant to proposed industry guidelines. The considerable variance noted highlights the need for greater oversight of the industry with clearly defined regulatory procedures.

Enhancing near infrared spectroscopy models to identify omega-3 fish oils used in the nutraceutical industry by means of calibration range extension

The high demand for omega-3 fish oil nutraceuticals (dietary supplements) is due to the numerous health benefits contributed by the polyunsaturated fatty acids. The nutraceutical industry is required to follow good manufacturing practice standards in order to ensure label claims and prevent adulteration. It is vital that the quality control procedures will be able to detect adulterated products. It is thus necessary to ensure that the analytical techniques are adequate by using validated methods. The qualification or identification of natural fish oils is a difficult task due to overlapping concentration ranges of polyunsaturated fatty acids and other similar properties. Gas chromatography is the prescribed technique in the nutraceutical industry for analysis of omega-3 fatty acids, but it is time-consuming and costly. Near infrared spectroscopy is a rapid and cost-effective technique which can replace the prescribed method if it is proven to be equivalent, through validation, to the criteria as prescribed by the pharmacopoeias and other industry guidelines. In this study, near infrared spectroscopy in combination with chemometrics was considered as an alternative method to gas chromatography to identify various commercial fish oils and to quantify the polyunsaturated fatty acids. Identification methods were developed for nine commercial omega-3 fish oils by using spectral libraries. Quantitative near infrared methods were developed for arachidonic acid, docosahexaenoic acid and eicosapentaenoic acid in fish oils expressed as mg.g−1 as well as % area using partial least squares regression and independent validation by superimposing datasets with mutual properties. Based on the statistics in terms of standard error of calibration, R2, standard error of prediction and r of the polyunsaturated fatty acid models, the near infrared method was equivalent to the prescribed gas chromatography methods, and precision results obtained were also within the prescribed criteria. Near infrared spectroscopy and chemometrics can be used for conclusive identification and quantification of omega-3 fish oils, thereby minimizing the risk of adulteration. The method also complied with the prescribed pharmaceutical method validation criteria, and therefore was proven as an alternative method to gas chromatography for the nutraceutical industry.

Cystatin C Is a More Reliable Biomarker for Determining eGFR to Support Drug Development Studies.

Glomerular filtration rate (GFR) is routinely used as a surrogate endpoint for the development of investigational drugs in clinical trials. GFR and staging of chronic kidney disease are typically assessed by measuring the concentration of endogenous serum biomarkers such as albumin and creatinine. However, creatinine is subject to high biological variability, and levels of creatinine do not rise until nearly 50% of kidney function is damaged, leading to inaccurate chronic kidney disease staging and false negatives. A newer biomarker for GFR, cystatin C, has been shown to be subject to less biological interference and more sensitive to early declines in kidney function. Cystatin C has also been shown to outperform creatinine as an indicator of true GFR and to add information about the occurrence of acute kidney injury. Comparison studies of cystatin C and creatinine continue to demonstrate its increased accuracy and sensitivity for changes in true GFR. While challenges remain for use of cystatin C, international agencies and working groups continue to validate cystatin C as a biomarker and accompanying GFR estimating equations for diagnostic and drug development use. In this review, we summarize these comparison studies, regulatory and industry guidelines, and clinical trial case studies for use of cystatin C in drug development.

Preharvest Farming Practices Impacting Fresh Produce Safety.

Advancements in agriculture and food processing techniques have been instrumental in the development of modern human societies. Vast improvements in agronomic practices, handling, and processing have allowed us to produce and preserve mass quantities of food. Yet despite all these innovations and potentially as a consequence of these mass production practices, more and more outbreaks of human pathogens linked to raw and processed foods are identified every year. It is evident that our increased capacity for microbial detection has contributed to the greater number of outbreaks detected. However, our understanding of how these events originate and what agronomic, packaging, and environmental factors influence the survival, persistence, and proliferation of human pathogens remains of scientific debate. This review seeks to identify those past and current challenges to the safety of fresh produce and focuses on production practices and how those impact produce safety. It reflects on 20 years of research, industry guidelines, and federal standards and how they have evolved to our current understanding of fresh produce safety. This document is not intended to summarize and describe all fruit and vegetable farming practices across the United States and the rest of the world. We understand the significant differences in production practices that exist across regions. This review highlights those general farming practices that significantly impact past and current food safety issues. It focuses on current and future research needs and on preharvest food safety control measures in fresh-produce safety that could provide insight into the mechanisms of pathogen contamination, survival, and inactivation under field and packinghouse conditions.

Safety performance indicators : a questioning diversity

Safety performance evaluation is an important issue of industrial risk management. If this statement is well accepted by the community, how to evaluate this performance does not meet consensus. The traditional incident-based approach has been shaken in 2007, after the Texas City refinery explosion. Accident report has pointed out confusion between personal safety and process safety, and between lagging and lagging indicators. Large number of thoughts and discussions has emerged regarding the use of safety performance indicators to measure level of risk. An indicator can be defined as a measurement, qualitative or quantitative, which provides information, in a specific objective of interpretation, in a particular context, for a specific actor. Almost 10 years after the Texas City accident, literature is now enriched with many proposals of set of indicators, emerging from scientific articles and industrial guidelines. Faced with this diversity of sources and management tools, we highlight the following question. What are the criteria for comparison, differentiation, and selection of these tools? Our study is based on an in-depth analytical review of the literature. As a result, several criteria seem to emerge: models used to design indicators, object of study, objectives of interpretation, terms of implementation and revision, actors affected by the outcome, and terms to validate the scientific relevance and operational feasibility. Multiplication of tools gradually improves the monitoring and driving of safety. However, our study shows that several criteria for indicators still need to be discussed, both theoretically and practically.

A conceptual framework of sustainable development strategy as “corporate responsibility” in manufacturing industry

AbstractPrevious studies have mentioned that there are market‐oriented corporate responsibility strategies, stakeholder‐oriented corporate responsibility strategies, and sustainable development‐oriented corporate responsibility strategies. Those strategies are in the form of corporate responsibility to the people, to the planet, and to profit (widely known as the triple bottom line). The very crucial challenge faced by the manufacturing industry today involves environmental degradation and depletion of natural resources, both of which can be overcome by implementing sustainable development‐oriented strategies. In this study, data were obtained from sampling three manufacturing industry companies in East Java, Indonesia. The respondents selected for the survey included top management and employees. From the results of the survey review and descriptive analysis, the researchers created a framework of the concept of sustainable development as corporate responsibility for the manufacturing industry. There are three steps in the methodology: strategic thinking, model arrangement, and variable definition. Arranging the model itself also involves three steps, identifying: “what is the problem,” “boundaries,” and “components.” The strategy model is in the form of a conceptual framework and strategy map, which are easily adapted as a guideline for the manufacturing industry. The model was tested using the Conceptual Framework for Strategic Sustainable Development and General Structural Component Analysis statistics. The conceptual model in this work used the five perspectives of responsibility applied within the manufacturing industry, which address the environment, social welfare, the intrinsic value of direct financial gain (in this context, this refers to competitive advantage), technology development, and performance management. Further research is needed to break down the conceptual framework and strategy map into more detailed, technical guidance.

APPLICATION OF 3D ECHOCARDIOGRAPHY GUIDANCE FOR WATCHMAN DEVICE IMPLANTATION

The Watchman device is a left atrial appendage (LAA) occlusion device, which is an effective alternative to oral anticoagulants in the prevention of thrombus formation in patients with atrial fibrillation (AF). Industry guidelines recommend standard 2D transesophageal echocardiography (TEE) images

Teaching Tip: The Development of an Interactive Computer-Based Training Program for Timely and Humane On-Farm Pig Euthanasia.

With extensive knowledge and training in the prevention, management, and treatment of disease conditions in animals, veterinarians play a critical role in ensuring good welfare on swine farms by training caretakers on the importance of timely euthanasia. To assist veterinarians and other industry professionals in training new and seasoned caretakers, an interactive computer-based training program was created. It consists of three modules, each containing five case studies, which cover three distinct production stages (breeding stock, piglets, and wean to grower-finisher pigs). Case study development was derived from five specific euthanasia criteria defined in the 2015 Common Swine Industry Audit, a nationally recognized auditing program used in the US. Case studies provide information regarding treatment history, clinical signs, and condition severity of the pig and prompt learners to make management decisions regarding pig treatment and care. Once a decision is made, feedback is provided so learners understand the appropriateness of their decision compared to current industry guidelines. In addition to training farm personnel, this program may also be a valuable resource if incorporated into veterinary, graduate, and continuing education curricula. This innovative tool represents the first interactive euthanasia-specific training program in the US swine industry and offers the potential to improve timely and humane on-farm pig euthanasia.

Preliminary Investigation into Urinary 1-Hydroxypyrene as a Biomarker for Polycyclic Aromatic Hydrocarbons exposure among Charcoal Workers in Ogun and Oyo States, Nigeria.

BackgroundUrinary 1-hydroxypyrene (1-OHP) has been widely used as a biomarker of polycyclic aromatic hydrocarbons (PAHs) in occupationally exposed workers. The objective of this study is to investigate the concentration of urinary 1-OHP among charcoal workers as subjects and non-charcoal workers as controls.MethodsEarly morning urine samples were collected from 68 persons (25 charcoal workers in Igbo-Ora, 20 charcoal workers in Alabata, and 23 non-charcoal workers) who volunteered to participate in this study. 1-OHP determination in urine samples was carried out using high performance liquid chromatography after hydrolysis. Descriptive and inferential statistics were used for data analysis at p < 0.05.ResultsThe mean urinary 1-OHP concentration (μmol/mol creatinine) among charcoal workers at Igbo-Ora and Alabata and non-charcoal workers were 2.22 ± 1.27, 1.32 ± 0.65, and 0.32 ± 0.26 (p < 0.01). There existed a relationship between respondent type and 1-OHP concentration. Charcoal workers were 3.14 times more at risk of having 1-OHP concentrations that exceed the American Conference of Governmental Industrial Hygienists guideline of 0.49 μmol/mol creatinine than non-charcoal workers (relative risk = 3.14, 95% confidence interval: 1.7–5.8, p < 0.01).ConclusionCharcoal workers are exposed to PAHs during charcoal production and are at risk of experiencing deleterious effects of PAH exposure. Routine air quality assessment should be carried out in communities where charcoal production takes place. Assessment of urinary 1-OHP concentration and use of personal protective equipment should also be encouraged among charcoal workers.

Space use by 4 strains of laying hens to perch, wing flap, dust bathe, stand and lie down.

The laying hen industry is implementing aviary systems intended to improve welfare by providing hens with more space and resources to perform species-specific behaviors. To date, limited research has examined spatial requirements of various strains of laying hens for performing key behaviors and none has been conducted within an alternative housing system. This study investigated the amount of space used by 4 strains of laying hens (Hy-Line Brown [HB], Bovans Brown [BB], DeKalb White [DW], and Hy-Line W36) to perform 5 different behaviors in the litter area of a commercial-style aviary. Hens were recorded standing [S], lying [L], perching [P], wing flapping [WF], and dust bathing [DB] on an open-litter area with an outer perch between 12:00 and 15:00 at peak lay (28 wk of age). Still images of each behavior were analyzed using ImageJ software for 16 hens per strain, and maximum hen length and width were used to calculate total area occupied per hen for each behavior. Brown hens required, on average, 89.6cm2 more space for S (P≤0.021) and 81.5cm2 more space for L (P≤0.013) than white hens. White hens used, on average, 572cm2 more space to perform WF than brown hens (P≤0.024) while brown hens used 170.3cm2 more space for DB than white hens (P≤0.022). On average, hens of all strains were wider while perching than the 15cm commonly recommended per hen (e.g., DW: 18.03; HB: 21.89cm), and brown hens required, on average, 3.38cm more space while perching than white hens (P≤0.01). Brown and white hens occupy different amounts of space when performing key behaviors. These differences, along with factors such as behavioral synchrony, clustering, and preferred inter-bird distances associated with these behaviors, should be considered when creating industry guidelines, crafting legislation and designing and stocking laying hen facilities to ensure hens can fulfill their behavioral needs.

Technical and safety challenges in emerging trends of near-field wireless power transfer industrial guidelines

Wireless power transfer (WPT) has reached commercialization stage in consumer electronics and manufacturing industry. New initiatives by industry for expanding the scope of wireless charging in extended short-range and mid-range applications for portable electronics and electric vehicles and are actively underway. In this article, the author addresses some technical challenges in near-field WPT applications on consumer electronics and electric vehicles. In addition, he shares his views on some of the emerging topics about recently proposed industrial guidelines. It is hoped that this article will arouse more interests and discussions on these emerging guidelines among the research and industrial communities so that future industrial standards will cater for all key aspects of user friendliness, health and safety.

A Study on the Effectiveness of Sales and Distribution Channel of Kansai Narolac Paints Ltd. Chhattisgarh

This Research Paper aims to study the distribution channels, sales network and service patterns of the paint sector through an analytical of Kansai Nerolac paints Company. The paper also tries to bring out the shortcomings, if any, in the present system and thus recommends suggestions to improve the same. The research paper also gives insights into the various financial terms, norms of the sales and service departments as per the guidelines of the paint industry.

Local fatigue strength assessment of induction hardened components based on numerical manufacturing process simulation

Induction hardening as common heat treatment process for highly-stressed automotive components significantly affects the surface layer properties leading to a compressive residual stress condition and a local hardening of the material. The beneficial effect of the post-treatment is generally well investigated and already implemented in industrial applicable guidelines by considering nominal fatigue strength enhancement factors. However, as the fatigue strength improvement essentially depends on the applied manufacturing process parameters, the resulting local material properties and the local load stress distribution, an elaborated numerical fatigue assessment procedure based on a manufacturing process simulation of a notched round specimen is presented in this paper. Thereby, a two-dimensional axi-symmetric model is set-up, whereby the inductive heating process is performed in COMSOL® and the subsequent quenching process in SYSWELD®. The resulting axial residual stress condition at the notch area of the specimen reveals a sound accordance to X-ray measurements. Finally, a local fatigue strength assessment based on the local strain approach is shown. Herein, manufacturing dependent residual stress states are considered as mean stresses on the basis of the damage parameter by Smith, Watson, and Topper. The estimated fatigue data points agree well to results of four-point bending fatigue tests, which basically prove the applicability of the presented fatigue design methodology.

In-company Situation and Development Strategy for Chinese Domestic Third-Party Logistics Providers (3PLPs)

With the rapid growth of logistics, it is important to gain further insight into the strategic benefits of logistics services. The study examines In-company situation of domestic 3PLPs. Based on the discussed background, the study analyses domestic 3PL companies in China Finally, the study recommends specific strategies to strengthen competitive power of global 3PLPs in China. This study provides a theoretical foundation for academics and also practical guidelines for logistics services industry

The Case Study on Korean Domestic In-company Third-Party Logistics Providers (3PLPs)

With the rapid growth of logistics, it is important to gain further insight into the strategic benefits of logistics services. The study examines the current situation of Korean domestic 3PLPs. Based on the discussed this, the study surveys In-company situation of Korean domestic 3PLPs. Finally, the study gets the survey results that common features of Korean domestic 3PLPs.This study provides a theoretical foundation for academics and also practical guidelines for logistics services industry