Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

UV and ambient light-induced modifications and related degradation of therapeutic proteins are observed during manufacturing and storage. Therefore, to ensure product quality, protein formulations need to be analyzed with respect to photo-degradation processes and eventually protected from light exposure. This task usually demands the application and combination of various analytical methods. This review addresses analytical aspects of investigating photo-oxidation products and related mediators such as reactive oxygen species generated via UV and ambient light with well-established and novel techniques.

Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic

Mechanical respirators typically use a plastic circuit apparatus to pass gases from the ventilator to the patient. Structural integrity of these circuits is crucial for maintaining oxygenation. Anesthesiologists, respiratory therapists, and other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade—the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.

Antibacterial and Freshness-Preserving Mechanisms of Chitosan-Nano-TiO2-Nano-Ag Composite Materials

With chitosan, nano-TiO2 and nano-Ag as raw materials, nano-TiO2 and nano-TiO2-Ag were modified by a surface modifier-sodium laurate. Chitosan (CTS), chitosan-nano-TiO2 (CTS-TiO2), and chitosan-nano-TiO2-nano-Ag (CTS-TiO2-Ag) composite materials and corresponding films were prepared by a solution co-blending method. Then, the antibacterial performances of the above three types of materials against Escherichia coli, Staphylococcus aureus, and Bacillus subtilis were compared. Moreover, potato and strawberry weight loss rates, peroxidase activity, and vitamin C contents after different film coating treatments were measured. Compared with CTS films, the CTS-TiO2-Ag and CTS-TiO2 composite films both showed better physical properties, and both demonstrated higher antibacterial effects, especially for E. coli. Measurement of physiological indices in fruits and vegetables showed that the freshness-preserving effect of CTS-TiO2-Ag coating films was the most significant. In all, the CTS-TiO2-Ag coating films can actively contribute to the storage of fruits and vegetables at room temperature, and better ensure product quality. Thus, such films are meaningful for research and development of new fruit freshness-keeping techniques and materials.

A Multidimensional Data Flow Driven-Based Quality Fluctuation Evaluation for Manufacturing Process

Real-time evaluation quality fluctuation is an important way to ensure product quality in manufacturing process. This study proposes a multidimensional data flow driven-based quality fluctuation evaluation. Firstly, the multidimensional decomposition and transition mode analysis is carried out to reveal the essence of quality fluctuation. Then, the technique uses hierarchical network architecture to model the process, and quality fluctuation network is built to track fluctuation evolution trend; then, the node relative entropy measure is defined to statistically analyze the change of net-node state fluctuation. Finally, a case study is used to verify the proposed quality fluctuation evaluation approach.

Intelligent Machine Vision Model for Defective Product Inspection Based on Machine Learning

Quality control is one of the industrial tasks most susceptible to be improved by implementing technological innovations. As an innovative technology, machine vision enables reliable and fast 24/7 inspections and helps producers to improve the efficiency of manufacturing operations. The accessible data by vision equipment will be used to identify and report defective products, understand the causes of deficiencies and allow rapid and efficient intervention in smart factories. From this perspective, the proposed machine vision model in this paper combines the identification of defective products and the continuous improvement of manufacturing processes by predicting the most suitable parameters of production processes to obtain a defect-free item. The suggested model exploits all generated data by various integrated technologies in the manufacturing chain, thus meeting the requirements of quality management in the context of Industry 4.0, based on predictive analysis to identify patterns in data and suggest corrective actions to ensure product quality. In addition, a comparative study between several machine learning algorithms, both for product classification and process improvement models, is performed in order to evaluate the designed system. The results of this study show that the proposed model largely meets the requirements for the proper implementation of these techniques.

Evaluation of the effectiveness of the activities of «KBhimmash named after A.M. Isaev» on quality assurance of rocket and space technology

В работе рассмотрены основные цели и задачи оценки эффективности деятельности организации по обеспечению качества ракетно-космической техники. Представлены результаты расчета показателей эффективности деятельности «КБхиммаш им. А.М. Исаева» по обеспечению качества продукции в 2019 году с использованием методики СТО ГК Роскосмос 1023-2019. Показано, что рассмотренная в статье методика позволяет проводить оценку эффективности деятельности «КБхиммаш им. А.М. Исаева» и разрабатывать рекомендации по повышению качества выпускаемой продукции. The paper considers the main goals and objectives of assessing the effectiveness of an organization to ensure the quality of rocket and space technology. Presented are the results of calculating the performance indicators of «KBhimmash im. A.M. Isaev» to ensure product quality in 2019 using the methodology of the STO GK Roscosmos 1023-2019. It is shown that the methodology considered in the article makes it possible to assess the effectiveness of the activities of «KBhimmash named after A.M. Isaev» and develop recommendations for improving the quality of products.

Edible Insects in Africa in Terms of Food, Wildlife Resource, and Pest Management Legislation

Entomophagy is an ancient and actually African tradition that has been receiving renewed attention since edible insects have been identified as one of the solutions to improve global nutrition. As any other foodstuff, insects should be regulated by the government to ensure product quality and consumer safety. The goal of the present paper was to assess the current legal status of edible insects in Africa. For that, corresponding authorities were contacted along with an extensive online search, relying mostly on the FAOLEX database. Except for Botswana, insects are not mentioned in national regulations, although the definitions for “foodstuff” allow their inclusion, i.e., general food law can also apply to insects. Contacted authorities tolerated entomophagy, even though no legal base existed. However, insects typically appear in laws pertaining the use of natural resources, making a permit necessary (in most cases). Pest management regulation can also refer to edible species, e.g., locusts or weevils. Farming is an option that should be assessed carefully. All this creates a complex, nation-specific situation regarding which insect may be used legally to what purpose. Recommendations for elements in future insect-related regulations from the food hygiene point of view are provided.

Study on Quality Prediction Technology of Manufacturing Supply Chain

Supply chain quality is the assurance of product quality in its full life-cycle. Although supply chain quality control is a hot topic among researchers, supply chain quality prediction is actually an important but unsolved problem in manufacturing industry. In this paper, an approach of manufacturing supply chain quality prediction based on quality satisfaction degree is proposed to control supply chain better, in order to help ensure product quality. Supply chain quality prediction 3D model and model based on customer satisfaction and process control are established firstly. And then technologies used in quality prediction are studied, including quality prediction index system established on Expert scoring -AHP and prediction workflow built on ABPM. Finally an example is given to illustrate this approach. The customer satisfaction prediction result of supply chain quality can help supply chain management, and the quality prediction software system can make it easier, which provides a new direction for the product quality control technology research.

In Vitro Quality Evaluation of Ciprofloxacin Tablets Marketed in Dessie, Ethiopia

Good quality medicines are a prerequisite for a successful treatment. Post marketing surveillance is very crucial to ensure product quality and eliminating substandard products to be distributed and, consequently, ensure better patient clinical outcome. Hence, this study assesses quality of six brands of ciprofloxacin tablets marketed in Dessie, Ethiopia using in vitro quality control tests. Weight variation test, disintegration test, dissolution test and assay for the content of active ingredients was done according to United sates Pharmacopoeia, 2007. The percentage content of ciprofloxacin tablets were within the range of 90-110% and the disintegration time was found between 2.375- 6.31 minutes. In addition, ciprofloxacin tablets released more than 80% of the drug after 30 minutes. Hence, all brands of ciprofloxacin tablets met the quality control parameters as per United States Pharmacopoeial specifications. Keywords: Ciprofloxacin; Quality; Substandard; Pharmacopoeial specifications

An Enhanced Method to Assess MPC Performance Based on Multi-Step Slow Feature Analysis

Due to the wide application of model predictive control (MPC) in industrial processes, the assessment of MPC performance is essential to ensure product quality and improve energy efficiency. Recently, the slow feature analysis (SFA) algorithm has been successfully applied to assess the performance of MPC. However, the disadvantage of the traditional SFA-based predictable index is that it can only extract one-step predictable information in the monitored variables. In order to better mine the predictable information contained in the monitored variables with large lag, an enhanced method to assess MPC performance based on multi-step SFA (MSSFA) is proposed. Based on the relationship between the slowness of slow features (SFs) and data predictability, an MSSFA model SFA(τ) is built through extending the temporal derivatives of the SFs from one step to multiple steps to extract multi-step predictable information in the monitored variables, which is used to construct a multi-step predictable index. Then, the predictable information in the SFs is further extracted for enhancing the multi-step predictable index to improve its sensitivity to performance changes. The effectiveness of the proposed method has been verified through two process simulation examples.