Strict Quality Standards Research Articles

Regulation and Safety of Cosmetics: Pre- and Post-Market Considerations for Adverse Events and Environmental Impacts

Cosmetic products have been increasingly regulated, particularly in Europe. With the introduction of the cosmetic regulation in 2013, stricter quality standards were implemented, surpassing those set by the 1976 legislation. The primary objective of these regulations is to safeguard consumer safety during the use of cosmetic products. Despite these advancements, certain regulatory gaps remain, indicating the need for more effective measures to enhance human and environmental health protection. Considering the aforementioned, this work aims to provide an overview of the current Cosmetics Regulation, highlighting the weakest cornerstones that represent the missing link keeping the core objective from being achieved. While there is ongoing reliance on historical data from animal studies, efforts are actively underway to replace these methods with new new approach methodologies for risk assessment. Additionally, regulatory authorities continue to improve environmental considerations in the assessment process. These measures, along with enhanced surveillance systems, are gradually addressing existing gaps and contributing to a more robust regulatory framework that balances market access with consumer safety. Legally non-compliant—or perhaps compliant but unknowingly dangerous—products may be used by people who relativize them as inherently safe, leading to adverse events. Whether caused by an underlying disease or purely by the chemical’s toxicity, these may never come to the attention of the authorities as they are generally under-reported, making it unfeasible to implement corrective or preventive measures to address their root cause. To illustrate, non-compliant products that have been detected by the Portuguese authority, INFARMED, I. P., from January 2018 to September 2023 are discussed, which were found to be potentially dangerous to human health and, therefore, withdrawn from the market.

Lost vegetables, lost value: Assessment of carrot downgrading and losses at a large producer organisation

Retailers usually impose strict private quality standards on fresh fruit and vegetable products, mainly focused on cosmetic features. At the supplier level, this generates a stream of suboptimal products that cannot be sold on the fresh market. This article studies the impact of these standards on suppliers by means of a direct quantification conducted in 2023 in the carrot supply chain of an Italian Producer Organisation. 34.64% of the carrots processed in terms of mass is downgraded because of non-compliance with the standards imposed by retailers, while 12.57% is lost at the primary stage due to food safety reasons. Downgrading occurs as a result of cosmetic imperfection (33.28% of mass) or because carrots are out-of-size (66.72%). The downgraded carrots are re-processed for industry, generating an additional loss of 15.27% of mass along the way. The economic loss linked to downgrading would account for 22.05% of potential turnover if no cosmetic quality standards were applied. By modelling a series of hypothetical scenarios, this article discusses the impact on the producer if the private quality standards imposed by retailers were more flexible.

Application of Statistical Process Control in Automotive Manufacturing

This research looks at how “statistical process control”, or SPC, is used in the automotive sector and highlights how it can improve production efficiency, lower defect rates, and improve process quality. SPC is crucial to the monitoring and control of the complex assembly processes and strict quality standards that define the automobile sector. The efficiency of several SPC methods, including control charts and process capability analysis (Cp and Cpk), in preserving process stability and fulfilling quality criteria is assessed in this study. The study shows how these technologies may detect process variations and direct appropriate adjustments to optimize output using simulated data analysis. The results highlight how crucial SPC is to attaining consistent product quality and reliability, which raises performance and safety requirements in the automotive sector.

Bridging the Gap: Quality by Design as a Catalyst for Enhanced Quality Management Systems in Biopharmaceutical Manufacturing.

The document emphasizes the importance of addressing key issues in Quality Management Systems (QMS) to stay competitive and provide high-quality goods and services in a dynamic market. It highlights the need to adopt novel quality management techniques for long-term success. The fundamentals of Quality by Design (QbD) are discussed, tracing back to pioneers like Joseph M. Juran and the Six Sigma concept for effective implementation. QbD is described as a systematic approach focusing on risk management, Quality Target Product Profile (QTPP), and Critical Quality Attributes (CQAs) to create products meeting predetermined quality standards. QbD incorporates quality concepts into the development and production processes. Its goal is to guarantee the quality of the product by determining and managing important factors. Manufacturers can be flexible with it while still adhering to strict quality standards. It signifies a change in the industry's paradigm.

Novel manufacturing process of pneumococcal capsular polysaccharides using advanced sterilization methods.

Pneumococcal disease is caused by Streptococcus pneumoniae, including pneumonia, meningitis and sepsis. Capsular polysaccharides (CPSs) have been shown as effective antigens to stimulate protective immunity against pneumococcal disease. A major step in the production of pneumococcal vaccines is to prepare CPSs that meet strict quality standards in immunogenicity and safety. The major impurities come from bacterial proteins, nucleic acids and cell wall polysaccharides. Traditionally, the impurity level of refined CPSs is reduced by optimization of purification process. In this study, we investigated new aeration strategy and advanced sterilization methods by formaldehyde or β-propiolactone (BPL) to increase the amount of soluble polysaccharide in fermentation supernatant and to prevent bacterial lysis during inactivation. Furthermore, we developed a simplified process for the CPS purification, which involves ultrafiltration and diafiltration, followed by acid and alcohol precipitation, and finally diafiltration and lyophilization to obtain pure polysaccharide. The CPSs prepared from formaldehyde and BPL sterilization contained significantly lower level of residual impurities compared to the refined CPSs obtained from traditional deoxycholate sterilization. Finally, we showed that this novel approach of CPS preparation can be scaled up for polysaccharide vaccine production.

Assessment of Lycopene Levels in Dried Watermelon Pomace: A Sustainable Approach to Waste Reduction and Nutrient Valorization

Watermelon suffers substantial post-harvest losses owing to strict quality standards, resulting in 20–30% of the crop being left unharvested. This study investigated the potential of valorizing dried watermelon pomace (DWP), a byproduct of watermelon juice extraction, focusing on its lycopene content—a potent antioxidant. This study assessed lycopene stability in DWP from four watermelon cultivars (Perla Nera®, Gavina®, Crimson Sweet, and Asahi Miyako) under different storage conditions (vial-sealed and vacuum-sealed). The lycopene content in freshly prepared DWP samples ranged from 0.734 to 1.572 mg/g db. The results indicated that vacuum-sealed samples exhibited significantly slower lycopene degradation than vial-sealed samples, highlighting the impact of air exposure on lycopene stability. After 90 days of storage, lycopene content in vacuum-sealed samples ranged from 0.214 to 1.234 mg/g db, while that in vial-sealed samples ranged from 0.013 to 0.731 mg/g db. Furthermore, this study assessed the effect of pretreatments with ascorbic acid (pretreatment A) and a mixture of ascorbic and citric acids (pretreatment B) on lycopene stability. Pretreatment B showed superior effectiveness, yielding higher lycopene levels than pretreatment A (p < 0.05). The stabilizing effects of ascorbic acid and citric acid were attributed to their antioxidant properties and their roles as pH regulators and chelators.

Manajemen Zero Antara Standard Kualitas Dan Dimensi Kualitas

This study aims to explore the concept of zero management in the context of quality standards and related quality dimensions. The research method used is theoretical research, which aims to develop a conceptual framework and theoretical understanding of zero management. The quality standards and quality dimensions used in this study are derived from existing literature. The results of the research indicate that zero management has significant potential to improve product and process quality through the elimination of defects and operational efficiency. The study also finds that the successful implementation of zero management is highly dependent on organizational commitment, adequate training, and the use of appropriate quality management tools. The conclusion of this study is that integrating zero management with strict quality standards and a deep understanding of quality dimensions can lead to significant improvements in overall organizational performance. This research contributes theoretically by offering a new perspective on how zero management can be applied and optimized in managerial practice.

Chemical-Saving Potential for Membrane Bioreactor (MBR) Processes Based on Long-Term Pilot Trials.

Membrane bioreactors (MBRs) have gained attraction in municipal wastewater treatment because of their capacity to meet strict water quality standards and support water reuse. Despite this, their operational sustainability is often compromised by high resource consumption, especially regarding the use of chemicals for membrane cleaning. This study explores innovative membrane-cleaning strategies to enhance the sustainability of MBR processes. Through long-term pilot trials at Stockholm's largest wastewater treatment plant, this study showed that alternative cleaning strategies can reduce chemical use by up to 75% without sacrificing treatment performance. The results further suggest that these alternative strategies could result in cost reductions of up to 70% and a reduction in environmental impacts by as much as 95% for certain indicators. Given that MBRs play a crucial role in addressing increasing treatment demands and advancing circular water management, the outcomes of this study are beneficial for the broader adoption of MBR processes. These results also have implications for existing installations, offering a pathway to more sustainable wastewater treatment. Moreover, the presented cleaning strategies provide significant opportunities for lowering operational costs and reducing the environmental footprint of new and existing MBR installations.

Hybrid Machine Learning Models for Fine-grained Air Quality Forecasting

Air pollution has become a major environmental issue that is causing many deaths each year and putting the environment and human health at serious risk. It causes the greenhouse effect, contributes to global warming, and increases the risk of lung cancer and other diseases that affect the respiratory system, including allergies. Setting and upholding strict air quality standards is essential to effectively combating air pollution. The air quality index (AQI) is a measurement used to determine the amount of pollutants in the atmosphere. By utilizing the capabilities of machine learning algorithms, precise forecasting of the fine-grained AQI is made feasible. To predict the AQI, a number of algorithms have been used, including logistic regression, decision tree regression, KNN, SVR, and linear regression. This project's main goal is to create models with machine learning algorithms and determine which model is best for AQI prediction.

Afflatoxine Effect on Livestock Health: A Review

Aflatoxins have been the cause of numerous deaths in livestock and it also the cause for economic losses. Aflatoxins belong to a group of mycotoxins that are produced by fungi species (molds) as they grow on their substrates. The major ones are aflatoxins B1, B2, G1 and G2, thus named depending on their fluorescence under blue and green light. Aspergillus parasiticus can synthesize AFB1, AFB2, AFG1, and AFG2. AFB1=AFM1>AFG1>AFB2=AFM2>AFG2 from strongest to weakest in terms of toxicity. Pigs so affected became lethargic, did not eat, and eventually became hypothermic, icteric, and had blood in their feces. Acute aflatoxicosis is characterized by an acute hepatotoxic disease that manifests itself with depression, anorexia, jaundice, hemorrhages, edema of the lower extremities, abdominal pain and vomiting. Chronic exposure leads liver cancer. The major target organ for aflatoxins in animals is the liver. Aflatoxins are probably not major causes of livestock disease and low productivity, but are contributing factors which are likely to become more important as livestock production intensifies. The animal feeds most likely to be contaminated are maize, cottonseed, and groundnuts. These feeds are at high risk for aflatoxin contamination. Aflatoxins cannot be detected by sight or smell in contaminated food or feed. Aflatoxins are not eliminated by boiling, cooking, or by processing into compound feeds. Animal source foods, especially milk, may also contain aflatoxins if animals eat contaminated feeds. This is often the case with milk; carry-over rates are relatively high, consumption is high, and milk is often given to infants and young children who are most at-risk for negative health outcomes related to aflatoxin exposure. Affected animals may exhibit reduced feed consumption, weight loss, and reduction in production. The more significant effects in cattle may occur when animals consume lower levels of aflatoxins and chronic effects appear such as reduced reproductivity, immunosuppression, and reduced feed efficiency. An increase in dietary protein protects against adverse effects of the toxin. Feeding of extra vitamins, A and K could also decrease the detrimental effects of aflatoxins. The prevention ways are removing the sources; promotes better agricultural and storage techniques; have good resources for testing and early diagnosis; strict food quality standards; General awareness and personal protection; Better livestock feeding & management.

A novel insecticide, isocycloseram, shows promise as an alternative to chlorpyrifos against a direct pest of peanut, Diabrotica undecimpunctata howardi (Coleoptera: Chrysomelidae).

Larvae of the southern corn rootworm (SCR) Diabrotica undecimpunctata howardi Barber (Coleoptera: Chrysomelidae) are primary pests of peanut in the Virginia-Carolina region of the United States, and are relatively sporadic pests in southern states such as Georgia, Alabama, and Florida. Peanuts have strict quality standards which, when they are not met, can diminish crop value by more than 65%. Management of direct pests like SCR is therefore crucial to maintaining the economic viability of the crop. The soil-dwelling nature of SCR larvae complicates management due to difficulties associated with monitoring and predicting infestations. Nonchemical management options are limited in this system; preventative insecticide applications are the most reliable management strategy for at-risk fields. Chlorpyrifos was the standard product for larval SCR management in peanut until its registration was revoked in 2022, leaving no effective chemical management option for larvae. We tested a novel insecticide, isocycloseram, for its ability to reduce pod scarring, pod penetration, and non-SCR pod damage in field studies conducted in Suffolk, Virginia in 2020-2022. Overall injury was low in 2020 and 2022, and in 2022 there was not a significant effect of treatment. In 2021, 2 simulated chemigation applications of isocycloseram in July significantly reduced pod scarring and overall pod injury relative to chlorpyrifos and the untreated control. Our results suggest that isocycloseram may become an effective option for managing SCR in peanut, although more work is needed to understand the mechanisms by which it is effective as a soil-applied insecticide.

Model-Matching Control for Low Switching Frequency Converters Unifying Different Performance Requirements

This paper presents an active damping control for LCL-filtered grid-connected converters to meet strict grid codes and power quality standards. The control strategy allows unifying into a single design procedure different requirements demanded by system operators. A model-matching approach is used to set the reference tracking and disturbance rejection transfer functions separately, which provides an additional degree of freedom to the converter control design. On the other hand, the measurement stage and digital implementation effects are considered in the control design to maximize the control bandwidth. The proposed control strategy uses a reduced number of sensors and is able to compensate unbalanced and distorted grid voltage conditions; it presents a systematic design and is formulated in the discrete-time domain, enabling a direct digital implementation. Performance assessment and comparison of different control strategies are performed using eigenvalue and transient response analyses. The effectiveness and advantages of the proposed strategy are validated through an experimental setup.

The influence of biomedical engineering in India

This comprehensive analysis delves into various crucial facets of biomedical engineering, covering cutting-edge technologies, creative methodologies, and ethical dilemmas. Quality Management Systems (QMS) play a pivotal role in maintaining precision, safety, and efficacy in lab experiments and biomedical product development, ensuring adherence to strict quality standards through guidelines like Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Advancements in medical imaging, from X-ray CT to molecular imaging, are revolutionizing disease diagnosis and treatment across multiple medical fields. Biomaterials and tissue engineering hold immense potential in regenerative medicine, addressing challenges like immune rejection and implant wear to meet diverse healthcare needs. Biomechanics and rehabilitation engineering merge biomechanical principles with assistive technologies to empower individuals with disabilities and improve their daily autonomy. Biomedical sensors, devices, and nanotechnology are driving personalized healthcare solutions, enhancing disease management through wearable and implantable technologies. Regulatory policies in India underscore the importance of strict regulations for medical devices and therapeutics to ensure safety and efficacy. Overall, this review highlights the transformative impact of biomedical engineering on healthcare advancements and societal well-being through responsible innovation and ethical practices.

Improving the Packaging Quality of Surgical Suture Products at PT. XYZ with the Application of the Six Sigma Method and Failure Mode Effect Analysis (FMEA)

The medical industry today upholds strict quality standards for medical products, including surgical sutures. PT XYZ, a leading manufacturer in this sector, faces challenges in mitigating surgical suture product defects. This research focuses on the packaging of surgical suture products produced by PT XYZ, with a focus on the production period from January to March. During this time period, there was a significant level of packaging production defects. The aim of future research is to improve the quality of packaging for surgical suture products. Specifically, it aims to identify the causes of defects in PT The Six Sigma method, using DMAIC, will be used in this research. The Define stage combines tools such as the Supplier, Input, Process, Output, and Customer (SIPOC) diagram, along with Critical to Quality (CTQ) identification. The Measure stage involves calculations using the P control chart, C control chart, DPMO, and sigma level. During the Analysis phase, a thorough analysis of the causes of failure is carried out using tools such as Pareto diagrams, fishbone diagrams, and Failure Mode Effects Analysis (FMEA). Moving to the Improve stage, FMEA identifies high-risk defects, including torn cartons, inconsistent colors, and damp cartons. Therefore, the proposed defect repair involves analysis of 5W 1H cartons. The results of the analysis provide alternative solutions such as increasing the frequency of replacing cutting tools on mold cutting machines, using cleaning aids on molding machines, and improving environmental monitoring SOPs in factories. An additional suggestion is to include antiseptic wet wipes in each carton of surgical suture products. After making improvements in the Improve stage, the final Control stage is carried out to assess the impact of the proposed changes on the company. The results show a positive impact, with an increase in the sigma value to 3.670.

The system for determining the technical acceptability of construction products – the experience of Europe and Asia

Determining the technical acceptability of construction products becomes a determining factor that shapes trade, innovation and safety standards. The article reviews the system of determining the technical acceptability of the EU and some Asian countries. The European experience, embodied by the CE marking system, establishes a uniform approach in the EU member states. The importance of studying the European experience is emphasized by the orientation of Ukraine towards joining the EU, which will be facilitated by the transition of the construction sector to European standards. European countries have harmonized standards, such as the EN series, which begin with basic requirements for construction products. CE marking combined with conformity assessment procedures ensures compliance with strict quality and safety standards. Competent authorities have successfully addressed the role of third-party verification, while the Construction Products Regulation (CPR) has a level of regulatory oversight. This experience offers Ukraine a model of harmonization, promoting the creation of a single market and strengthening international confidence in its construction products. Asian countries, each with its own regulatory field, exemplify diverse approaches to determining technical acceptability. Countries such as Japan and China emphasize adherence to national standards and certification processes. The Japanese JIS standards and the JIS mark together with the Construction Quality Assurance (CQA) system are technical compliance standards not only in construction. Understanding the nuances of approaches in Asia gives Ukraine knowledge about adapting its own systems to regional requirements. The study of international approaches to the construction of a system for determining the technical acceptability of construction products and structures will contribute to international trade, ensuring the quality and safety of products, and innovations. Cross-border projects and the attraction of foreign investments contribute to the introduction of international practices that meet global standards. The introduction of the European system for determining the technical acceptability of building materials, which corresponds to the best international practices, not only the competitiveness of Ukrainian construction products, but also thanks to the global standardization of the construction industry, the economic integration of sustainable development, the experience of Europe and Asia allow to create a road map to ensure technical acceptability of construction products.

Evaluasi Kualitas Air Minum di Kampus Universitas Siliwangi Menggunakan Parameter Fisika, Kimia, dan Mikrobiologi

Every person has a fundamental need to drink water. However, the environment today presents conditions—like the clean water crisis—that every person needs to be aware of. Compared to other water demands, drinking water must meet strict quality standards because it will enter the body. As a result, in order to assess the drinking water quality in the vicinity of Siliwangi University Tasikmalaya using Peraturan Menteri Kesehatan Republik Indonesia Nomor 492/MENKES/PER/IV/2010, research must be conducted. In this investigation, three types of water samples were collected from a single drinking water source: spring water, filtered water, and water that has undergone ultraviolet (UV) light processing. In this investigation, chemical, physical, and biological characteristics were taken into consideration. The three samples' chemical and physical parameters results surpass the quality standards. Nevertheless, the three samples did not comply with the standard of quality microbiologically.

Specifics of creating clinical abstract of biospecimens

One technology that helps overcome the problem of low research reproducibility is biobanking, which involves maintaining strict quality standards at all stages. In addition to data on the biosample (detailed documentation on sampling, transportation, preparation and subsequent storage), one of the key points is the availability of information about the donor (patient). The aim of this article was to analyze creating clinical abstract of biospecimens, combining data from various biobanks and assessing the possibilities of electronic medical records and other modern technologies for this. The search for publications was carried out in the PUBMED, eLIBRARY.RU, RSCI databases. One approach to creating a clinical description is the targeted collection of information by a specially trained employee. Primary information is most often taken from the individual records of the study participant, which are developed and approved when planning work. An alternative method is the use of electronic medical records and other documents that collect information during the assessment and treatment of patients. There are also mixed types of clinical data collection, a prime example of which is the UK Biobank. Completeness, structure, and standardization are essential characteristics of clinical description associated with biospecimens. Various standards are currently being developed to unify clinical description, making biobanks and collections more available to external researchers and organizations, which is necessary for collaboration and more efficient use of stored biospecimens. Harmonization of clinical description methodology between different biobanks open up broad boundaries for large- scale research within personalized and translational medicine.

Image quality assessment of retinal fundus photographs for diabetic retinopathy in the machine learning era: a review.

This study aimed to evaluate the image quality assessment (IQA) and quality criteria employed in publicly available datasets for diabetic retinopathy (DR). A literature search strategy was used to identify relevant datasets, and 20 datasets were included in the analysis. Out of these, 12 datasets mentioned performing IQA, but only eight specified the quality criteria used. The reported quality criteria varied widely across datasets, and accessing the information was often challenging. The findings highlight the importance of IQA for AI model development while emphasizing the need for clear and accessible reporting of IQA information. The study suggests that automated quality assessments can be a valid alternative to manual labeling and emphasizes the importance of establishing quality standards based on population characteristics, clinical use, and research purposes. In conclusion, image quality assessment is important for AI model development; however, strict data quality standards must not limit data sharing. Given the importance of IQA for developing, validating, and implementing deep learning (DL) algorithms, it's recommended that this information be reported in a clear, specific, and accessible way whenever possible. Automated quality assessments are a valid alternative to the traditional manual labeling process, and quality standards should be determined according to population characteristics, clinical use, and research purpose.

Application of Machine Learning Algorithms to Classify Peruvian Pisco Varieties Using an Electronic Nose.

Pisco is an alcoholic beverage obtained from grape juice distillation. Considered the flagship drink of Peru, it is produced following strict and specific quality standards. In this work, sensing results for volatile compounds in pisco, obtained with an electronic nose, were analyzed through the application of machine learning algorithms for the differentiation of pisco varieties. This differentiation aids in verifying beverage quality, considering the parameters established in its Designation of Origin". For signal processing, neural networks, multiclass support vector machines and random forest machine learning algorithms were implemented in MATLAB. In addition, data augmentation was performed using a proposed procedure based on interpolation-extrapolation. All algorithms trained with augmented data showed an increase in performance and more reliable predictions compared to those trained with raw data. From the comparison of these results, it was found that the best performance was achieved with neural networks.

Enhanced Simultaneous Nitrogen and Phosphorus Removal Performance of the AGS-SBR Reactor Based on the Effects of the C/N Ratio and Microbial Community Change

In recent years, the development of AGS technology will likely lead to a new direction in wastewater treatment development in the future. Traditional sewage treatment technology has been unable to meet the increasingly strict quality standards of wastewater treatment and limited land requirements. AGS technology may be a new method to replace traditional sewage treatment technology. However, the stable operation of AGS technology is a major obstacle to the popularization and development of this technology. The C/N ratio is an important parameter affecting the stability and simultaneous nitrogen and phosphorus removal of AGS technology. In order to enhance the nitrogen and phosphorus removal capacity of a low-load aerobic granular sludge SBR (AGS-SBR) system, changes in the morphology, EPS, and simultaneous removal of organic matter, nitrogen, and phosphorus in the AGS system were studied by regulating different C/N ratios (20, 15, 10, 5). The changes in the microbial community in the system were deeply analyzed by high-throughput sequencing technology. The results showed that different C/N ratios have a significant effect on the nitrogen removal rate of AGS but have little effect on the removal rate of organic matter and phosphorus. When the C/N ratio was reduced to 10, it was conducive to the stability of the low-load AGS-SBR system. An effective C/N ratio promoted the secretion of EPS by microorganisms, and the increase in the PN value contributed to the stability of the granular sludge, which became smooth and compact. The main functional genus in the system were norank_f__Saprospiraceae, Tetrasphaera, Ellin6067, and Pseudomonas. In addition, the simultaneous nitrogen removal performance of the system was significantly improved.