Stages Of Development Process Research Articles

Technology of interdisciplinary open-ended designing in engineering education

Author’s technology of interdisciplinary open-ended engineering is presented in this article. This technology is an integrated teaching method that significantly increases the practical component in the educational program. Author’s technology creates the conditions to overcome the shortcomings in the engineering education. The basic ideas of the technology of open-ended engineering, experience of their implementation in higher education and the author’s vision of the teaching technology are examined in the article. The main stages of development process of the author’s technology of open-ended engineering to prepare students (bachelor) of technical profile are presented in the article. Complex of the methodological tools and procedures is shown in the article. This complex is the basis of the developed training technology that is used in educational process in higher school of engineering (UrFU). The organizational model of the technology of open-ended engineering is presented. Organizational model integrates the functions in the creation and implementation of all educational program. Analysis of the characteristics of educational activity of students working on author’s technology of interdisciplinary open-ended engineering is presented. Intermediate results of the application of author’s technology in the educational process of the engineering undergraduate are shown.

Bridging the Gap from Pilot Plant Experimental Records to Life Cycle Inventory

Conducting life cycle assessment (LCA) at pilot-scale can help chemical and pharmaceutical industries to generate environmental load data, identify environmental hotspots, and provide options for building sustainable manufacturing plants from the process design and development stage. However, collecting life cycle inventory (LCI) data is time intensive and may be arduous for process development. In this paper, a systematic methodology was developed to bridge quickly the gaps between pilot plant operation and LCI and, also, scale up to predict LCI at industrial scale. According to the ISO 14040 series of standards for LCA, the methodology classifies various data-available scenarios and integrates experimental measurements with engineering and empirical calculations to provide suitable data for LCI. This methodology builds a reliable, convenient, and easy to follow basis, which enables industrial process developers to gain a much clearer view of the environmental footprint at the process design stage, there...

Relating saturation capacity to charge density in strong cation exchangers

In this work the relation between physical and chemical resin characteristics and the total amount of adsorbed protein (saturation capacity) for ion-exchange resins is discussed. Eleven different packing materials with a sulfo-functionalization and one multimodal resin were analyzed in terms of their porosity, pore size distribution, ligand density and binding capacity. By specifying the ligand density and binding capacity by the total and accessible surface area, two different groups of resins were identified: Below a ligand density of approx. 2.5μmol/m2 area the ligand density controls the saturation capacity, while above this limit the accessible surface area becomes the limiting factor. This results in a maximum protein uptake of around 2.5mg/m2 of accessible surface area. The obtained results allow estimating the saturation capacity from independent resin characteristics like the saturation capacity mainly depends on “library data” such as the accessible and total surface area and the charge density. Hence these results give an insight into the fundamentals of protein adsorption and help to find suitable resins, thus limiting the experimental effort in early process development stages.

Optimization-based framework for resin selection strategies in biopharmaceutical purification process development.

This work addresses rapid resin selection for integrated chromatographic separations when conducted as part of a high‐throughput screening exercise during the early stages of purification process development. An optimization‐based decision support framework is proposed to process the data generated from microscale experiments to identify the best resins to maximize key performance metrics for a biopharmaceutical manufacturing process, such as yield and purity. A multiobjective mixed integer nonlinear programming model is developed and solved using the ε‐constraint method. Dinkelbach's algorithm is used to solve the resulting mixed integer linear fractional programming model. The proposed framework is successfully applied to an industrial case study of a process to purify recombinant Fc Fusion protein from low molecular weight and high molecular weight product related impurities, involving two chromatographic steps with eight and three candidate resins for each step, respectively. The computational results show the advantage of the proposed framework in terms of computational efficiency and flexibility. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:1116–1126, 2017

Monitoring Glycosylation Profile and Protein Titer in Cell Culture Samples Using ZipChip CE-MS

Rapid and sensitive product quality analysis is important for real-time monitoring during biopharmaceutical development and manufacturing. However, low level of protein concentration and complex cell culture matrix pose challenges for product quality characterization at early stages of cell line selection and process development. Here, we describe a fast and simple microfluidic ZipChip CE-MS method to measure quality attributes of monoclonal antibody protein directly from cell culture supernatant. Cell culture supernatant samples were characterized with charge-based separation using microfluidic capillary electrophoresis coupled to a high-resolution mass spectrometer. Under sample reducing conditions, multiple protein glycosylation attributes were determined on the heavy chain, whereas titer information was obtained from comparison of light chain signal intensity following sample spiking-in with heavy labeled mAb. Therefore, the protein expression and product quality can be monitored using the same method with a single microfluidic device. A total volume of ten to fifty microliter of cell culture supernatant is needed, whereas analysis time is within three minutes per sample. In addition, comparison of new method with traditional RP-LC-MS method using a set of time-course bioreactor cell culture samples has been performed. A good correlation of the levels of N-glycosylation attributes between ZipChip CE-MS of crude samples and RPLCMS analysis following Protein A (ProA) purification step has been demonstrated.

An Assessment of Stakeholder Participation on the Development of Iskandar Malaysia

This paper examines the stakeholder involvement in the development process during the establishment of Iskandar Malaysia development through qualitative and quantitative research methods. The analysis from questionnaire survey was triangulated with the interview analysis in order to provide a comprehensive overview on the process. Analyses indicated that respondents lacked the necessary awareness about the development that led to low participation in the development process of Iskandar Malaysia. Furthermore, the top-down decision making approach in Iskandar Malaysia, has led to limited involvement of the public in the overall planning of Iskandar Malaysia. Assimilation of information at all stage of development process to the public and community representatives are necessary in promoting quality and transparent decision. Good governance principal can only be achieved if the authority takes the initiative to promote bottom up approach and integrate the direct participation of the stakeholders in the formulation and planning of the region.

Deflagration to detonation transition in mechanoactivated mixtures of ammonium perchlorate with aluminum

Deflagration-to-detonation transition (DDT) in aluminum-ammonium perchlorate (Al/AP) loose-packed charges (80% porosity) has been studied. The charges were manufactured from preliminary mechanoactivated mixtures. The mixtures placed in steel tubes 10 mm in diameter were ignited by Nichrome wire. It was found that it is possible to distinguish three parts corresponding to different stages of DDT process development. Steady-state detonation velocity reached the level of 2500 m/s at the distance of 90 mm from the ignition point.

Generic flowsheet model for early inventory estimates of industrial microbial processes. II. Downstream processing

To ensure optimal process flowsheet selection it is valuable to conduct environmental and economic comparisons at an early stage of technology selection and process design. However, the data that is needed to perform these studies are not available at this stage of process development. This is also true for bioprocess systems. To overcome the lack of data, the CeBER (Centre for Bioprocess Engineering Research, University of Cape Town) Bioprocess Modeller was developed to provide material and energy values for industrial microbial processes.This paper presents the downstream processing portion of this flowsheet. The model allows for solid–liquid separation, cell disruption, concentration and formulation units as required. The model allows section of appropriate downstream processing units include, amongst others, centrifugation, filtration, precipitation and freeze-drying. At each downstream processing stage, non-reacting and reacting chemicals can be added. The model provides both a material inventory as well as the calculation of the energy input required and waste heat generated.Additionally, the model includes a database of values (including constants, operating conditions and others), drawn from various industrial norms and academic sources. Should specific information not be known, the model selects the most appropriate values based on other decisions made through the model.

Using Green Chemistry and Engineering Principles To Design, Assess, and Retrofit Chemical Processes for Sustainability.

The concepts of green chemistry and engineering (GC&E) have been promoted as an effective qualitative framework for developing more sustainable chemical syntheses, processes, and material management techniques. This has been demonstrated by many theoretical and practical cases. In addition, there are several approaches and frameworks focused on demonstrating that improvements were achieved through GC&E technologies. However, the application of these principles is not always straightforward. We propose using systematic frameworks and tools that help practitioners when deciding which principles can be applied, the levels of implementation, prospective of obtaining simultaneous improvements in all sustainability aspects, and ways to deal with multiobjective problems. Therefore, this contribution aims to provide a systematic combination of three different and complementary design tools for assisting designers in evaluating, developing, and improving chemical manufacturing and materials management systems under GC&E perspectives. The WAR Algorithm, GREENSCOPE, and SustainPro were employed for this synergistic approach of incorporating sustainability at early stages of process development. In this demonstration, simulated ammonia production is used as a case study to illustrate this advancement. Results show how to identify process design areas for improvements, key factors, multicriteria decision-making solutions, and optimal trade-offs. Finally, conclusions were presented regarding the tools' use in more robust sustainable process and material management designs.

Progress and challenges in large-scale expansion of human pluripotent stem cells

The constant supply of high cell numbers generated by defined, robust, and economically viable culture processes is indispensable for the envisioned application of human pluripotent stem cells (hPSCs) and their progenies for drug discovery and regenerative medicine. To achieve required cell numbers and to reduce process-related risks such as cell transformation, relative short batch-like production processes at industry- and clinically-relevant scale(s) must be developed and optimized. Here, we will review recent progress in the large-scale expansion of hPSCs with particular focus on suspension culture, which represents a universal strategy for controlled mass cell production. Another focus of the paper relates to bioreactor-based approaches, including technical aspects of bioreactor technologies and operation modes. Lastly, we will discuss current challenges of hPSC process engineering for enabling the transition from early stage process development to fully optimized hPSC production scale operation, a mandatory step for hPSCs’ industrial and clinical translation.

Quantitative Sustainability Analysis: A Powerful Tool to Develop Resource-Efficient Catalytic Technologies

Demand for chemicals is growing. In fact, the chemical industry’s global output is expected to nearly double its 2010 volume by 2020. Lessening the collateral environmental burden of such growth requires sustainable alternative technologies. Fortunately, green chemistry and engineering research has made remarkable progress, laying the foundation for developing efficient processes that conserve feedstock and energy. Life cycle assessment (LCA) also plays a key role by identifying environmental hotspots along the supply chain, either within the manufacturing plant (catalysts, solvents, reactors, separators) or upstream during raw material extraction or during the generation of fossil-based energy at any stage. We present several examples that illustrate how important it is to incorporate LCA with techno-economic analysis—especially during the early stages of process development. This approach is not just useful, it is an essential tool for the rational development of sustainable chemical processes.

Effect of Sampling Frequency for Real-Time Tablet Coating Monitoring Using Near Infrared Spectroscopy.

While the sampling of pharmaceutical products typically follows well-defined protocols, the parameterization of spectroscopic methods and their associated sampling frequency is not standard. Whereas, for blending, the sampling frequency is limited by the nature of the process, in other processes, such as tablet film coating, practitioners must determine the best approach to collecting spectral data. The present article studied how sampling practices affected the interpretation of the results provided by a near-infrared spectroscopy method for the monitoring of tablet moisture and coating weight gain during a pan-coating experiment. Several coating runs were monitored with different sampling frequencies (with or without co-adds (also known as sub-samples)) and with spectral averaging corresponding to processing cycles (1 to 15 pan rotations). Beyond integrating the sensor into the equipment, the present work demonstrated that it is necessary to have a good sense of the underlying phenomena that have the potential to affect the quality of the signal. The effects of co-adds and averaging was significant with respect to the quality of the spectral data. However, the type of output obtained from a sampling method dictated the type of information that one can gain on the dynamics of a process. Thus, different sampling frequencies may be needed at different stages of process development.

Integration of LCA in R&D by applying the concept of payback period: case study of a modified multilayer wood parquet

PurposeImproving technical properties and the durability of wood-based products by modification in various processing technologies is subject to recent research and development activities. This study aimed at integrating environmental considerations during the research and development phase of a novel modification process for a multilayer wood parquet. Due to expected challenges when applying Life Cycle Assessment (LCA) in this phase, the eco-profile of the modified multilayer wood parquet was referred to the original multilayer parquet by estimating payback period and identifying other payback options.MethodsAn LCA was conducted during the research and development phase of the modification process at laboratory scale and is characterized as ex ante environmental screening of a newly developed technology. The environmental assessment of new products and manufacturing processes during the research and development phase, however, faces multifarious challenges, such as the definition of a functional unit and the service life length. In order to overcome these challenges, the idea was to answer the question under which circumstances the modification process pays back from the perspective of non-renewable energy use and global-warming potential. Aside from investigation of payback period, the feasibility of other payback options was systematically searched.Results and discussionThe extra resource input and the resulting increase in environmental burden of the modification of the multilayer parquet can be justified with the extension of service life length by 10 to 20 %, referring to global warming potential and non-renewable energy use, respectively. Other payback options found were adjusting chemical loading during modification, making renovations superfluous, or reducing transport effort. Other than transportation and renovation, which are user-dependent, only the modification lies within the scope of the parquet producer.ConclusionsThe payback concept is found suitable for comparative estimations on the magnitude of change in environmental performance of product variants during research and development. By investigating on multiple payback options, it was enabled to frame the change in environmental performance, which is essential in order to define the scope of further research and development in a target-oriented way. The possibility of using LCA for an environmental technology valuation at an early stage in product and process development is demonstrated in this study.

Community Capacity in Providing Neighborhood Unit-scale Social Infrastructure in Supporting Surakarta Child Friendly

The top-down approach cause the programs of child friendly social infrastructure development uncertain in its sustainability. This paper used scoring technique in identifying the neighborhood characteristics and community capacity in providing child friendly social infrastructure in Surakarta. The neighborhood characteristics were viewed from the provision of social infrastructure service capacity, then the community capacity was measured from the level of participation in the stage of development process. The results showed that the community had capacity in providing child friendly social infrastructure and its supporting facility, even though it could not entirely attend the level of degree of citizen power.

Transfer of Emulsion Polymerization of Styrene and n‐Butyl Acrylate from Semi‐Batch to a Continuous Tubular Reactor

The transfer of a semi‐batch emulsion copolymerization to a single feed continuous recipe is investigated herein. A single feed continuous tubular reactor is used in the presented study in accordance with the requirement of minimizing the number of dosing streams. The correlation between operating parameters and the product properties are experimentally presented for the semi‐batch as well as for the single feed continuous tubular reactor. It is shown that the transfer from semi‐batch to continuous smart‐scale tubular reactor needs to be direct as opposed to via a batch reactor. The particle sizes and molecular masses obtained in the tubular reactor are similar to those of the semi‐batch process. However, the adjustment of the polymer composition is challenging. Using monomer addition as a means to influence chemical composition is not applicable. Thus, in the tubular reactor the chemical composition of the resulting copolymer depends on the initial monomer composition and reaction temperature. Nevertheless, the mass transfer of the emulsion polymerization damps the copolymer composition distribution (CCD) drift for higher initial monomer contents compared to bulk polymerization. It is shown that transfer of a semi‐batch product to a continuous recipe is possible in early stages of process development. image

Identifying crop productivity constraints and opportunities using focus group discussions: A case study with farmers from Tigray

Crop productivity in many places in Sub Saharan Africa is low. This affects food security and rural livelihoods. Identification of constraints and opportunities is a first and essential step in development processes aiming at improving crop productivity. Macro- and meso-level diagnostic methods frequently point to soil fertility and agronomic practices as major constraints. In Tigray, our study area in Northern Ethiopia, we applied focus group discussion in four locations to identify productivity constraints and opportunities. Outcomes in the form of “mind maps” were quantified to allow comparison between the locations. We found that, apart from some similarities, outcomes demonstrated much diversity. Location specific conditions and agronomic factors were considered main constraints by farmer groups in all locations. Soil fertility measures were considered a main opportunity. However, other categories of constraints and opportunities, like economic factors and irrigation, were diverse for the locations involved. Observed outcome variability was supported by descriptive biophysical and socio-economic data. We concluded that superficial identification of constraints and opportunities neglected contextual diversity. Making such diversity visible is essential in understanding and addressing this complexity. Applying approaches like focus group discussion, therefore, offers important opportunities at grassroots-level to give farmers a mandate and responsibility at early stages of development processes.

A machine learning based software process model recommendation method

Among many factors that influence the success of a software project, the software process model employed is an essential one. An improper process model will be time consuming, error-prone and cost expensive, and further lower the quality of software. Therefore, how to choose an appropriate software process model is a very important problem for software development. Current works focus on the selection criteria and often lead to subjective results. In this paper, we propose a software process model recommendation method, to help project managers choose the most appropriate software process model for a new project at an early stage of development process according to historical software engineering data. The proposed method casts the process model recommendation into a classification problem. It first evaluates the different combinations of the alternative classification and attribute selection algorithms, and the best one is used to build the recommendation model with historical software engineering data; then, the constructed recommendation model is used to predict process models for a new software project with only a few data. We also analyze the mutual impacts between process models and different types of project factors, to further help managers locate the most suitable process model. We found process models are also responsible for defect count, defect severity and software change. Experiments on the data sets from 37 different development teams of different countries show that the average recommendation accuracy of our method reaches up to 82.5%, which makes it potentially useful in practice.

Survey: Dealing Non-Functional Requirements at Architecture Level

Non-functional requirements (NFRs) are being addressed by the architecture. NFRs are not focused properly as functional requirements (FRs) are dealt and focused. FRs are being taken under consideration at the early stage of software process development (such as architectural level). Usually, the NFRs are being focused at the end of the project, which does not fulfill the desired qualities. Early design decision is very important to achieve a strong connection between design and requirements, quality of a system and a consistent software product. Architecture and NFRs constraint each other therefore, they should be treated together. Runtime NFRs (such as performance, security and fault tolerance) and some of those which are not runtime (such as maintainability) should be considered at the architectural level. This paper presents a survey that emphasizes the integration of NFRs and architectural. We have analyzed the reported techniques on the basis of our evaluation criteria and have presented a comparison.

A scale-down mimic for mapping the process performance of centrifugation, depth and sterile filtration.

ABSTRACTIn the production of biopharmaceuticals disk‐stack centrifugation is widely used as a harvest step for the removal of cells and cellular debris. Depth filters followed by sterile filters are often then employed to remove residual solids remaining in the centrate. Process development of centrifugation is usually conducted at pilot‐scale so as to mimic the commercial scale equipment but this method requires large quantities of cell culture and significant levels of effort for successful characterization. A scale‐down approach based upon the use of a shear device and a bench‐top centrifuge has been extended in this work towards a preparative methodology that successfully predicts the performance of the continuous centrifuge and polishing filters. The use of this methodology allows the effects of cell culture conditions and large‐scale centrifugal process parameters on subsequent filtration performance to be assessed at an early stage of process development where material availability is limited. Biotechnol. Bioeng. 2016;113: 1934–1941. © 2016 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.

A Holistic Approach for Planning and Adapting Quality Inspection Processes Based on Engineering Change and Knowledge Management

Adaptability of inspection and testing activities in manufacturing systems is of high importance for sustaining quality of products and production processes. However, process models identifying the demand for changing quality testing activities as well as methodologies for systematic adaption of ongoing quality inspection processes are deficient. This is related to the fact that existing inspection planning procedures are primarily related to product and process development stages and not to ongoing series production. Furthermore, knowledge acquired by modifying ongoing quality inspection activities is seldom used systematically to improve inspection planning for future product and process development. This paper presents a holistic approach for inspection planning covering the systematic change and adaption process of inspection activities during manufacturing stage as well as knowledge transfer to future product and process development. By the evaluation of inspection-related change demand, suitable design options for inspection process modification can systematically be derived. Based on the paradigm of engineering change management (ECM), the adaption of quality inspection processes can be planned, assessed and implemented. Finally, knowledge acquired by implementing inspection process modifications is transferred to inspection planning for future product and process development by using concepts of knowledge management.