Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality

In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.

Mitigating the effects of COVID-19: an exploratory case study of the countermeasures taken by the manufacturing industry

Purpose The purpose of this study is to understand how manufacturers (both discrete and process) are managing disruptions amid the COVID-19 pandemic outbreak, using UAE as an empirical context. Design/methodology/approach This research uses a multiple case study approach and undertakes 36 semi-structured interviews with senior management of four discrete and four process manufacturing firms that outsource products/components from overseas and domestic suppliers. Findings Results reveal that manufacturing firms are using six distinct actions to mitigate the effects of the COVID-19 pandemic. For instance, they are relying on the automation process, transferring new and updated knowledge to the current and new suppliers, managing workforce diversity, understanding the impact of demand’s disruption, managing the ecosystem and finally using digital technologies to mitigate the impact of the COVID-19 pandemic. Research limitations/implications This study has some limitations. Firstly, the results of this study cannot be generalized to a broader population as it attempts to build an initial theory in manufacturing supply chains within the context of a pandemic outbreak. Second, the study uses a cross-sectional approach to explore the actions used by manufacturing firms to mitigate the effects of the COVID-19 pandemic. Practical implications Manufacturing firms can replicate the actions proposed in this study to lessen the effect of the COVID-19 pandemic and emerge stronger in the post-COVID-era. Originality/value This study contributes to the manufacturing supply chain literature within the context of pandemic outbreaks by exploring the steps taken by manufacturing firms to minimize the effects of the COVID-19 pandemic. Particularly, it explores such steps by considering both the discrete and process manufacturing industries within the United Arab Emirates.

Teaching-Learning Strategies to Production Planning and Control Concepts: Application of Scenarios to Sequencing Production with Virtual Reality Support

This paper aims to present scenarios to be applied in higher education to the theme of production planning and control, addressing factors of the production system and indicators arising from this process and the application of virtual reality to support the process. The applied method combines the development of six scenarios for virtual reality application and the discussion about the impacts in indicators from the production planning and control, for example, inventory in the process, manufacturing lead-time, use of equipment, and punctual delivery attendance. Findings revealed that the teaching-learning process of production planning and control, when applied through scenarios, generates opportunities for students to learn the impact in the indicators. The virtual reality in this environment supports creating differentiated teaching-learning environments to generate the most significant knowledge for students which positively impacts the future in the world of work. In addition, it allows people involved in the teaching-learning processes of production engineering to apply the concepts presented in the sequencing process, lean about the impacts of decisions on production sequencing indicators and appreciate the support of virtual reality to generate an environment more cognitive for students.

Conceptualized Improvement on Transparent Glass Die for a Robust Manufacturing Process

Glass die are one of the materials used by semiconductor plants during production of specialized quad-flat no-leads (QFN) products. With its transparent appearance and fragile characteristics, several challenges are encountered and analyzed to resolve unwanted issues and to have a robust process manufacturing. This paper will discuss a potential concept of process improvement on the side of the device’s manufacturing with pattern recognition capability as detection and identification of the material to be processed. The paper will also discuss different options that can be selectively considered with respect to the manufacturer’s capability of their process flow.

Sand-sodium-silicate mixtures grains composition optimization for structuring by steam-microwave solidification method

Mixture sizes of sand-sodium-silicate conglomerates and sodium silicate solute content in them influences on the basic physical and technological indicators of molding and core mixtures structured in steam-microwave environment have been investigated. Sand-sodium-silicate mixture structured by steam-microwave environment (steam-microwave solidification method – SMS-process) composition has been optimized. Standard and generally accepted methods and techniques of molding mixtures investigation have beenused in this study. For mixtures manufacturing have been used: quartz sand brand 1K2O202; sodium silicate solute with silicate modulus of 2.8…3.0 and specific gravity of 1.42…1.44 g/cm3. Quartz sand cladding has been implemented with 0.5 and 2.5% sodium silicate solute (by weight, over 100% sand). Sand-sodium-silicate conglomerates have been scattered in sieves and conglomerates with sizes less than 0.315mm and with sizes from 0.315 to 0.63mm have been used for research. Mixture composition has been optimized according to results of simplex planning and experimental data by simplex triangles constructing and superimposing their formatted images on each other with darkened fields between isolines that do not meet of each parameters required level. To plot simplex lattices, model with simplex lattice plan of incomplete cube in Scheffe’s triple system has been used. For the first time, influence of mixture sand-sodium-silicate conglomerates sizes and sodium-silicate-solute content in them on basic indicators of mold and rod mixtures structured in steam-microwave environment has been established, and their composition has been optimized. Data obtained will be useful in molds and rods structured by SMS-process manufacturing. They will have predictable indicators of properties that correspond to their allowable level. Optimal composition of sand-sodium-silicate mixture, structured by SMS-process, is mixture of quartz sand, part of which passed through sieve with cell of 0.315 mm and have sodium silicate solute content (МSiO2=2.8…3.0, 2=1.42…1.44 g/сm3) in amount of 1.5% (by weight, over 100% quartz sand). Keywords.Sand, silicon silicate solute, steam-microwave solidification, optimization, conglomerates, strength, gas permeability, crushability, density, beam deflection, knockout energy.