Phases Of Development Process Research Articles

A circular economy framework for the assessment of bio-based value chains

Circular economy, the new trend to think, do, use, and produce, poses new challenges in redesigning the industrial Value Chains (VCs). Achieving sustainability is stimulating innovation in existing markets and imposing differentiations in value chains with pioneering processes and products. An essential requirement in the pursuit of solutions is the existence of an evaluation framework that fosters circularity right from the initial phases of process and product development. This article focuses on establishing the connection between circularity strategies and the Technology Readiness Level (TRL) in various domains, specifically in innovative material production, such as bio-plastic bottle closures, multifunctional rubber panels, and wood composite bearings, within alternative value chains. This methodological approach was verified in the framework of the European Union funded GREEN-LOOP project to demonstrate the feasibility of producing bio-based materials. A comprehensive analysis of the value chain mapping was carried out, accompanied by the evaluation of circular economy practices at each stage. The assessment established a roadmap to enhance the value chain from both technological and environmental perspectives, as illustrated in the Circular Value Chain Canvas. The results have shown that the implementation of the circularity concepts already in the design phase can effectively support the Circular Economy transition.

A Co-Simulation Model Integrating a Musculoskeletal Human Model with Exoskeleton and Power Tool Model

Working at and above head height with a power tool represents a common activity in craft and assembly applications. To assist and protect the user from overload and injuries in these situations, the development and use of application-specific support systems, such as exoskeletons and power tools, have greatly increased in recent years. Thus, the integration of aspects of the user-centered product development of support systems in the early phases of product development process has high potentials. A common approach to integrate the user early in the product development process is the use of musculoskeletal human models, which allow the evaluation of effects on the human body. This could also be applicable in the mentioned use case to enable the evaluation of the interactions for the user. Therefore, a co-simulation model for virtual modelling and simulating human–machine interactions is presented. The co-simulation model is made up of a musculoskeletal human model and the models of the technical systems (exoskeleton and power tool). By applying the co-simulation model, the impact of technical systems on the human body can be taken into account to derive design alternatives for the technical system due to the requirements of the user. The paper describes the design of the co-simulation model and particularly, the interaction of the submodels. The evaluation of the co-simulation model is carried out with the help of a subject study for the selected use case working at and above head height. The results show plausible results for the muscle loads considering the support by an exoskeleton. Furthermore, the comparison of simulated results to measured muscle activations via surface electromyography shows a good agreement. Thus, the co-simulation model passes the test for functionality and seems to be applicable for the derivation of design alternatives of technical systems regarding the user needs. In future, the co-simulation model will be further validated with a higher number of subjects and to implement design alterations in the technical systems.

Adaptive Security Activities Selection Model Using Multi-Criteria Decision-Making Methods

Adaptive security activities are a list of recommended security activities to be integrated smoothly with the software development life cycle (SDLC) to produce a secure application software. Adaptive security activities are needed due to the emergence of factors and constraints which have been determined as one of the reasons for the underutilisation of security activities implementation, especially in the earlier phase of software development process. Security activities selection models were proposed to select and recommend security activities but the models were focused on certain factors or as a solution for specific constraints, and thus the recommended security activities were not adaptive. Consequently, an adaptive security activities selection (ASAS) model was proposed by combining the factors and constraints faced by the development team in selecting security activities. The model consisted of two integrated multi-criteria decisionmaking (MCDM) methods, namely Analytic Network Process (ANP) and Reference Ideal Method (RIM). ANP was used to prioritise and weight the criteria while RIM was used to measure and evaluate the security activities with the value of constraints in regard to each criterion. To validate the model a case study was performed on four inhouse web application development teams in the Malaysian public sector. The proposed model was able to recommend security activities in the requirement and design phase based on different constraints faced by each of the development teams. The model was adaptive due to its flexibility and ability to change and suit different evolved conditions when recommending the security activities.

Quality by Digital Design for Developing Platform RNA Vaccine and Therapeutic Manufacturing Processes.

Quality by digital design (QbDD) utilizes data-driven, mechanistic, or hybrid models to define and optimize a manufacturing design space. It improves upon the QbD approach used extensively in the pharmaceutical industry. The computational models developed in this approach identify and quantify the relationship between the product's critical quality attributes (CQAs) and the critical process parameters (CPPs) of unit operations within the manufacturing process. This chapter discusses the QbDD approach in developing and optimizing unit operations such as in vitro transcription, tangential flow filtration, affinity chromatography, and lipid nanoparticle (LNP) formulation in mRNA vaccine manufacturing. QbDD can be an efficient framework for developing a production process for a disease-agnostic product that requires extensive experimental and model-based process-product interaction characterization during the early process development phase.

OPTIMIZATION INTERNATIONAL AIRPORT CAPACITY I GUSTI NGURAH RAI BALI

This study discuss about optimization capacity on land new to I Gusti Airport International Ngurah Rai, Bali with review evaluation capacity moment this . Development Airport Ngurah Rai consists of of 2 ( two ) stages . Stage One consists of from development international terminal capacity 189,000 meters square . For Step second , development in the form of international terminal expansion to 265,891 meters. Development process stage I requires reclamation land area of 47 ( four twenty seven ) hectares , and when it's 35 ( three twenty five) hectares has reclaimed . Whereas the rest still in the licensing process and targeted done mid December 2018. Development process Phase II will need reclamation land area of 71 ( seven twenty one ) hectare . Based on plan development Stages I and II are the addition of an apron covering an area of 47.9 hectares so need conducted calculation optimization capacity airport Ngurah Rai with consider adequate condition of the apron and runway given by PT Angkasa Pura I considering that condition expansion more carry on will difficult because cost development consequence crisis global pandemic and vulnerable damage surroundings _ _ waters airport that can damage area . Study this aim for knowing amount movement the plane that will wearing a new apron To use serve movement aircraft in 2022. Analysis _ started with needs runway length in Maximum Take - off Weight (MTOW) for type aircraft largest operating _ in 2019 (Boeing 747 – 400), next analyze amount runway capacity and prediction year 2022 in operation mix (Take – off/Landing), and do analysis linear regression for estimate amount movement aircraft optimally for _ 2022. Continued _ with determine score rmonth , Rday , and the later Rhour multiplied with score results regression for get score Nmonth , Nday , and Nhour . Nhour value in year planning . Analysis result show evaluation condition existing runway 3000 m to runway needs with aircraft Boeing 747 – 400ER plan , then results correct to influence height from sea level (Fe) is 3323.4 m, while correct to influence temperature air (Ft) obtained 3620.4 m. amount movement aircraft in 2022 results _ analysis operating runway capacity arrival just is 18 operations per hour, for operation departure just is 44 operations per hour, whereas for operation mixture is 58 operations per hour. The result of parking stand requirements is obtained in class of aircraft 3 C as many as 34 parking stands and 4C as many as 45 parking stands. From result determination new apron capacity in 2022 with _ total dimensions 122130.4 m 2 . Next recommended for conducted analysis more carry on in the form of arrangement of parking stands on land reclamation stages I and II. for 2022 .

A Digital Twin-Based Approach for the Optimization of Floor-Ball Manufacturing

The increasing complexity of products and manufacturing processes, combined with the constantly advancing technological integration of the manufacturing sector, raised new challenges for world-class industries to optimize time-to-market, resources, and cost. Simulation, as an essential Industry 4.0 enabling technology, allows one to emulate the steps of a manufacturing process, thereby achieving significant improvements in all the product and process development phases. A simulation process can be implemented and improved by creating the Digital Twin of the manufacturing system, which can be realized on a single-line scale or extended to the whole factory. The Digital Twin merges physics-based system modeling and real-time process data to generate a virtual copy of an observable object to reduce and optimize the extensive time and cost of physical design, prototyping, commissioning, reconfiguration, and maintenance. This study aims to investigate how the implementation of digital twin technology can help optimize the balance between power consumption and productivity, taking into account existing barriers and limitations. By following this outline, this study shows the design and development of a digital twin for a floor-ball manufacturing line present in the Smart Factory of Ostschweizer Fachhochschule (Switzerland). The entire production process is reproduced with Siemens Technomatix Plant Simulation software 2201, and data connection and processing are handled by a tailored toolchain consisting of an agent, a database, Python packages, and the COM interface from Tecnomatix. This toolchain feeds the digital twin with data from the physical operating environment. In particular, this study compares direct power measurements with the ones expected by the digital twin to assess digital model accuracy.

Implementasi Blueprint Sistem Informasi Monitoring Pelanggaran Siswa di MAN 1 Padangsidimpuan dalam Bentuk Aplikasi Website

This research intends to incorporate a blueprint design for a student violation information system that was developed in earlier research into a website-based application to record student violations at MAN 1 Padangsidimpuan. The needs analysis, system design, software development, testing, and implementation phases of the website application development process are all included in this study's waterfall methodology. The PHP programming language, the CodeIgniter framework, and the MySQL database were used to create this application. This study produced a web tool that MAN 1 Padangsidimpuan can utilize to more efficiently monitor student infractions. This program is anticipated to assist schools in managing student infractions, delivering transparency to both students and parents, and enhancing student conduct in the classroom.

Validation of model-based design of experiments for continuous wet granulation and drying

This paper presents an application case of model-based design of experiments for the continuous twin-screw wet granulation and fluid-bed drying sequence. The proposed framework consists of three previously developed models. Here, we are testing the applicability of previously published unit operation models in this specific part of the production line to a new active pharmaceutical ingredient. Firstly, a T-shaped partial least squares regression model predicts d-values of granules after wet granulation with different process settings. Then, a high-resolution full granule size distribution is computed by a hybrid population balance and partial least squares regression model. Lastly, a mechanistic model of fluid-bed drying simulates drying time and energy efficiency, using the outputs of the first two models as a part of the inputs. In the application case, good operating conditions were calculated based on material and formulation properties as well as the developed process models. The framework was validated by comparing the simulation results with three experimental results. Overall, the proposed framework enables a process designer to find appropriate process settings with a less experimental workload. The framework combined with process knowledge reduced 73.2% of material consumption and 72.3% of time, especially in the early process development phase.

Abstract 19 CD34+ Cell Isolation from Cord Blood: A Novel Option for Faster, More Consistent Outcomes

Abstract Introduction Immunomagnetic isolation of cells has been long established but still suffers from drawbacks when used for hemopoietic stem cells (HSCs) in cord blood. [Kekarainen et al., 2006] Limitations with HSC isolation from cord blood include steep learning curves, time consuming manual labor, and inconsistent outcomes. [de Wynter et al., 1999; Perdomo-Arciniegas and Vernot, 2011] FerroBioTM has developed a semi-automated system for CD34+ cell isolation from unmodified cord blood (Fig 1A) as a means to provide fast, effective, and consistent isolations. Objectives The purpose of this work is to explore process improvements for the FerroBioTM system. Additionally, this work aims to characterize the resulting cell isolates. Methods The cell isolation protocol was evaluated by flow cytometry for cell counts, viability, and purity (total n=195). Protocol modification included incubation time at various steps, magnetic bead dosing, temperatures, and volumes. The ‘percent of cells captured’ was calculated as the difference between starting CD34 and non-captured CD34 cells. Cryopreservation tolerance was evaluated by freeze-thawing cells in a dimethyl sulfoxide-based media and measuring viability via hemocytometry (n=3). Sterility testing on cell isolates was performed via BacT/ALERT iNST & iAST (n=2). Results Incubation time did not have a significant effect on the efficiency of bead-cell binding (Fig 1B). As the FerroBioTM protocol progressed, final cell purity and viability increased and became more consistent (Fig 1C, D). Additionally, over the same phases of process development, final cell recovery increased 4-fold, from 6.5%±5.9% to 28.1%±9.7%. Post-cryopreservation viability was 78.8%±3.3%. Sterility tests were negative for anaerobic and aerobic bacteria. Discussion By establishing that bead-cell incubation duration did not significantly influence outcomes, the incubation time was considerably reduced, bringing the total processing time to ~3hrs. That said, if an overnight incubation is preferable for an operator’s workflow, the data suggests the process could be flexible to meet such needs. Iterations of the process have also resulted in significant improvements to final cell recovery while maintaining high purity and viability. Additional work is being done to further improve recovery. The initial investigation of sterility and cryopreservation was encouraging, and assays for cell functionality are underway. Figure 1. (A) The FerroBioTM hardware, shown with a cartridge in which cell isolation occurs. (B) The proportion of cells that successfully bound magnetic beads as a function of bead-cell incubation time. Final cell (C) purity and (D) viability, shown at different phases of chronological process development. Statistics: GraphPad Prism 9, 1-way ANOVA followed by a Tukey’s HSD. * p < 0.05, **** p < 0.0001. Each data point corresponds to one CBU.

When and how to implement design thinking in the innovation process: A longitudinal case study

Design thinking is viewed as an attractive approach to fostering innovation. Interest in this area has increased significantly in recent years, and an increasing number of firms employ this approach, especially in the early stages of the innovation process, in which context design thinking is used to gain insights into user needs and generate new ideas. However, empirical evidence regarding the timing and process associated with the deployment of design thinking during the three different phases of the innovation process (fuzzy front end, development and testing, and commercialization) remains very limited. This gap may hinder research and practical advancements regarding when and how to implement design thinking in the innovation process. We explore this problem through a case study of a leading Chinese technology firm in the refrigeration industry using a longitudinal lens. We show that when and how the firm uses the four design thinking practices—(1) user-centeredness, (2) embracing diversity, (3) visualization and (4) iteration—to enable a transition from the fuzzy front end to development and testing and ultimately to commercialize a new product. Moreover, our findings suggest that the firm needs to adapt to the changing innovation goals and dynamically adjusts the content and intensity of design thinking practices as the innovation phase progresses. These findings therefore offer practical guidance for managers adopting design thinking to promote innovation.

THE EFFECT OF ADOPTING RAPIDLY EMERGING TECHNOLOGY ITEMS DURING THE DEVELOPMENTAL PHASE ON SYSTEMS ENGINEERING DESIGN IN AVIATION INDUSTRY

Requests from stakeholders to include Rapidly Emerging Technology Items into the system under development during the design phase become essential to maintain competitiveness. This paper aims to analyze the effect of adopting the Rapidly Emerging Technology Items (RETIs) during the development process phase of the Systems Engineering approach. Subject matter experts were surveyed with various qualitative questions. Purposeful sampling was used in choosing participants who were "information-rich." Therefore, the individuals and sites selected should be knowledgeable people who have experience in engineering projects' technical and managerial aspects. Referring to the pattern of the data and the author's reflexivity, five themes were identified in this paper, including the problem validation, design professionality, the drivers of the Rapidly Emerging Technology Items (RETIs), the technology type, interaction between the design organization and the RETIs drivers, and the tool for evaluating the rapidly emerging technologies. The analysis of the themes revealed that, due to the adoption of RETIs, the design organization needs to re-define the requirements, re-verify and re-validate the System-Of-Interest (SOI), which leads to longer time in system design and increases the allocated budget. Finally, improvement interventions are required to ensure that RETIs are adopted efficiently throughout the development phase.

Guidelines for Future Agile Methodologies and Architecture Reconciliation for Software-Intensive Systems

Background: Several methodologies have been proposed since the first days of software development, from what is now named traditional/heavy methodologies, and later their counterpart, the agile methodologies. The whole idea behind agile methodologies is to produce software at a faster pace than what was considered with plan-based methodologies, which had a greater focus on documenting all tasks and activities before starting the proper software development. Problem: One issue here is that strict agilists are often against fully documenting the software architecture in the first phases of a software process development. However, architectural documentation cannot be neglected, given the well-known importance of software architecture to the success of a software project. Proposed Solution: In this article, we describe the past and current situation of agile methodologies and their relation to architecture description, as well as guidelines for future Agile Methodologies and Architecture Reconciliation. Method: We propose a literature review to understand how agile methodologies and architecture reconciliation can help in providing trends towards the success of a software project and supporting software development at a faster pace. This work was grounded in General Systems Theory as we describe the past, present, and future trends for rapid systems development through the integration of organizations, stakeholders, processes, and systems for software development. Summary of results: As extensively discussed in the literature, we found that there is a false dichotomy between agility and software architecture, and then we describe guidelines for future trends in agile methodologies and reconciliation of architecture to document agile architectures with both architectural decisions and agile processes for any system, as well as future trends to support organizations, stakeholders, processes, and systems.

Lyophilized Progenitor Tenocyte Extracts: Sterilizable Cytotherapeutic Derivatives with Antioxidant Properties and Hyaluronan Hydrogel Functionalization Effects.

Cultured primary progenitor tenocytes in lyophilized form were previously shown to possess intrinsic antioxidant properties and hyaluronan-based hydrogel viscosity-modulating effects in vitro. The aim of this study was to prepare and functionally characterize several stabilized (lyophilized) cell-free progenitor tenocyte extracts for inclusion in cytotherapy-inspired complex injectable preparations. Fractionation and sterilization methods were included in specific biotechnological manufacturing workflows of such extracts. Comparative and functional-oriented characterizations of the various extracts were performed using several orthogonal descriptive, colorimetric, rheological, mechanical, and proteomic readouts. Specifically, an optimal sugar-based (saccharose/dextran) excipient formula was retained to produce sterilizable cytotherapeutic derivatives with appropriate functions. It was shown that extracts containing soluble cell-derived fractions possessed conserved and significant antioxidant properties (TEAC) compared to the freshly harvested cellular starting materials. Progenitor tenocyte extracts submitted to sub-micron filtration (0.22 µm) and 60Co gamma irradiation terminal sterilization (5-50 kGy) were shown to retain significant antioxidant properties and hyaluronan-based hydrogel viscosity modulating effects. Hydrogel combination products displayed important efficacy-related characteristics (friction modulation, tendon bioadhesivity) with significant (p < 0.05) protective effects of the cellular extracts in oxidative environments. Overall, the present study sets forth robust control methodologies (antioxidant assays, H2O2-challenged rheological setups) for stabilized cell-free progenitor tenocyte extracts. Importantly, it was shown that highly sensitive phases of cytotherapeutic derivative manufacturing process development (purification, terminal sterilization) allowed for the conservation of critical biological extract attributes.

Overview of transparency and inspectability mechanisms to achieve accountability of artificial intelligence systems

Abstract Several governmental organizations all over the world aim for algorithmic accountability of artificial intelligence systems. However, there are few specific proposals on how exactly to achieve it. This article provides an extensive overview of possible transparency and inspectability mechanisms that contribute to accountability for the technical components of an algorithmic decision-making system. Following the different phases of a generic software development process, we identify and discuss several such mechanisms. For each of them, we give an estimate of the cost with respect to time and money that might be associated with that measure.

Development of a high-temperature double-layer bulge test for failure prediction in gas-based hot forming of a high-strength aluminium alloy

In order to meet the continuously increasing environmental concerns, automotive lightweight concepts of replacing steels with high strength aluminium alloys are one promising solution. Therefore, complex automotive structural components manufactured with new processes like rapid gas-based hot sheet metal forming can become a key factor from a forming technology point of view. A product and process development phase, which is mainly assisted by numerical simulations, mandates knowledge of the material forming limits under the process conditions. The aim of this work is to determine the FLD of a 6xxx precipitation-hardening aluminium alloy within the solution heat treatment temperature range under gas-based hot forming process conditions. For this purpose, a hydraulic double-layered bulge test, as introduced by Banabic, is used as the basis and a high-temperature test setup as well as a characterization methodology are established. FE simulations are utilized to optimize the specimen geometries aiming at specific strain paths. Experiments are conducted with the optimized specimen geometries and the high-temperature FLD is extracted. The FLD is further used in simulations for process parameter identification for failure-free gas-based hot forming of a laboratory scale benchmark component. Experimental validations showed the reliability of the methodology and the determined FLD for failure prediction in the novel forming process.

Manifestation of People’s Participation in The Existing Local Government Acts in Bangladesh

Whether it is agenda setting, policy formulation or implementation, people’s participation at all levels of policy process, decision-making and service delivery has become the prime prerequisite in the prevailing development paradigm. Although in practice there remains huge argument regarding people’s effective involvement in the development process due to unwillingness of the supply side and inefficiency, political ignorance of the demand end, it is an undeniable fact that the government of Bangladesh in the recent past has enacted laws for all levels of local government bodies with especial focus given on the people’s participation in different phases of development process. This study aims at reconnaissance of the degree of rights and opportunity given to the general people to participate in the development process presented in the existing Local Government Acts, both in rural and urban local government tiers. The study mainly focuses on the secondary sources, exclusively on the existing Local Government Acts and ordinances. The study finds that all acts have significantly included the opportunities for local people to participate in the decision-making process. It is interesting to say that the lower the tier of local government, the higher opportunity to participate in decision making process. Social Science Review, Vol. 38(1), June 2021 Page 1-16

Swarm intelligence-based model for improving prediction performance of low-expectation teams in educational software engineering projects.

Software engineering is one of the most significant areas, which extensively used in educational and industrial fields. Software engineering education plays an essential role in keeping students up to date with software technologies, products, and processes that are commonly applied in the software industry. The software development project is one of the most important parts of the software engineering course, because it covers the practical side of the course. This type of project helps strengthening students’ skills to collaborate in a team spirit to work on software projects. Software project involves the composition of software product and process parts. Software product part represents software deliverables at each phase of Software Development Life Cycle (SDLC) while software process part captures team activities and behaviors during SDLC. The low-expectation teams face challenges during different stages of software project. Consequently, predicting performance of such teams is one of the most important tasks for learning process in software engineering education. The early prediction of performance for low-expectation teams would help instructors to address difficulties and challenges related to such teams at earliest possible phases of software project to avoid project failure. Several studies attempted to early predict the performance for low-expectation teams at different phases of SDLC. This study introduces swarm intelligence -based model which essentially aims to improve the prediction performance for low-expectation teams at earliest possible phases of SDLC by implementing Particle Swarm Optimization-K Nearest Neighbours (PSO-KNN), and it attempts to reduce the number of selected software product and process features to reach higher accuracy with identifying less than 40 relevant features. Experiments were conducted on the Software Engineering Team Assessment and Prediction (SETAP) project dataset. The proposed model was compared with the related studies and the state-of-the-art Machine Learning (ML) classifiers: Sequential Minimal Optimization (SMO), Simple Linear Regression (SLR), Naïve Bayes (NB), Multilayer Perceptron (MLP), standard KNN, and J48. The proposed model provides superior results compared to the traditional ML classifiers and state-of-the-art studies in the investigated phases of software product and process development.

Using a process simulation platform for reviewing automated airport baggage handling system configurations

The use of digital manufacturing platforms is becoming increasingly important since they facilitate process visualisation, optimisation, and validation, allowing engineers to make informed decisions at early product and process development phases. In this paper, the potential of using process simulation platforms is explored in order to visualise and validate baggage handling processes involving robotic handling systems and human operators. Multiple baggage handling layout configurations are digitally constructed and reviewed with the aim to investigate cost, time, and flexibility performance indicators. Furthermore, the advantages of using digital manufacturing and process simulation platforms are discussed.

Process Validation in Pharmaceutical Product Development: An Overview

As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity.
 A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance.
 Keywords: GMP, Validation, validation manufacturing process.

Spiritual Growth and Social Entrepreneurship: Understanding the integration of spirituality and social entrepreneurial process

The business world today is moving from capitalism to social entrepreneurship. Social entrepreneurs view a social mission as an explicit and central one than following the path of individual wealth creation. Seizing opportunities and utilizing resources are the key factors that influencing entrepreneurial process. Entrepreneur’s belief system is shaped or process of interpretation that makes entrepreneurs pursue solutions to social problems. Transcends from wealth creators to social warriors may be explained by focusing on their spiritual orientation (Ganzin, Islam, & Suddaby, 2020). The objective of the study is to explore the connection of spirituality development to social entrepreneurial process of social entrepreneurs. The paper offers a new theoretical conceptualization in relation to understanding how spiritual growth influences social entrepreneurs. Thus, the paper tries to build up the relationship between spiritual growth and social entrepreneurial process. As such, our paper strengthen the existing social entrepreneurship theory by introducing the spirituality dimension to the cognitive process and highlights the trigger points related to social entrepreneurial behavior that transcendence individual wealth creation. Furthermore, the linkage between the attributes of social entrepreneurial process and spiritual development phases is an eye opening to both spiritual and entrepreneurial studies.
 Keywords: Social entrepreneurship, Spiritual growth, Entrepreneurial process