A Perspective on Challenges and Prospects for Applying Process Systems Engineering Tools to Fermentation-Based Biorefineries

Reflections on the development of scenario and problem-based chemical engineering projects

A systematic methodology for the design of continuous active pharmaceutical ingredient production processes

Challenges and Opportunities in Pharmaceutical Manufacturing Modeling and Optimization

This article describes the development and implementation of a methodology for evaluating the effectiveness of model data exchanges between Systems Engineering tools. The context of the work is the SEDRES (System Engineering Data Representation and Exchange Standardization) project. This is a European initiative toward the development of a standardized data exchange capability. The paper addresses the issues of the use of this capability, and its potential influence on the System Engineering process. It describes the development of the evaluation framework and methods that were tested and refined for the SEDRES model data exchange context. Results that demonstrate the potential benefits of adopting the standards-based approach are described and a number of issues relevant to its applicability in the support of integrated product teams are discussed. © 2001 John Wiley & Sons, Inc. Syst Eng 4: 13–23, 2001

Optimization-based decision support methodology for the synthesis of negative-emissions biochar systems

The paradigm shift in the pharmaceutical industry to continuous manufacturing, which has recently progressed from conceptual demonstration to pilot production, has stimulated the development and application of process systems engineering (PSE) tools for implementing efficient and robust control strategies. In this study, a systematic framework for process control design and risk analysis for continuous pharmaceutical solid-dosage manufacturing is proposed, consisting of system identification with state-space models; control design and analysis metrics; hierarchical three-layer control structures; risk mapping, assessment and planning (Risk MAP) strategies; and control performance indicators. The framework is applied to a feeding-blending system, wherein the major source of variance in the product quality arises. It can be demonstrated that the variance in the feeding-blending system can be mitigated and managed through the proposed systematic framework for control design and risk analysis. The process analytical technology (PAT) tool for mass fraction measurement of active pharmaceutical ingredient (API) and its relative standard deviation (RSD) were indispensable to achieve an efficient control design at the advanced layers. Specifically, the improvements in control performance by implementing advanced model-based control strategy are found to be limited by model-plant mismatch and the sampling time of the PAT tools.

The infusion of engineering (CogE) methods and tools into traditional systems engineering processes and practices is becoming an important priority as the systems engineering community begins to tackle system of systems (SoS) problems. As one illustration, the military is interested in creating cognitively-inspired systems (as small as a PDA and as large as a weapon platform) that maximally exploit human potential while also accelerating both human supported and automated decision making. To date, engineering has been successfully applied to the planning and requirements definition phases of systems engineering (also known as front-end analysis) but has yet to be infused into the remaining phases of systems engineering. To span the full systems engineering lifecycle, it is important, first and foremost, to communicate the return-on-investment to the various stakeholders to get their buy in. The second question that needs to be answered is whether or not cognitive engineering is ready for primetime. This paper presents promising technical and management strategies to overcome the challenges in introducing engineering into system-of-systems engineering (SOSE). Specifically, it presents a representative set of engineering methods and tools to span the full SoS life-cycle as well as engineering awareness initiatives to penetrate both the DoD acquisition community and commercial industry.

Throughout AT&T Federal Systems Advanced Technologies (FSAT), many systems engineering processes were used by the various organizations, making it difficult to compare measures of effectiveness for each project's process. About one year ago, FSAT management chartered a Process Management Team (PMT) to develop a standard Systems Engineering process for FSAT. After one year, the PMT issued a generic Systems Engineering process document that will be used by all projects within FSAT. The process can be tailored to either commercial or government contracts and conforms to MIL‐STD‐499B. The standard process has been modeled in a computer‐aided engineering tool and is available to new projects on a computer disc. To support the process, special courses were developed to teach process fundamentals and give projects a jump‐start. In addition, a metrics program has been established that monitors and provides feedback to all projects using the standard or tailored process.

This paper describes research into the application of Model-Based Systems Engineering (MBSE) tools and processes to Risk-Informed Design (RID). RID enables system risk analyses early in the lifecycle of spaceflight projects allowing designers to use risk as a design commodity and part of the overall trade space. RID uses a “minimum functionality” approach, whereby a minimal, single-string system design is first envisioned that only meets basic performance requirements without any regard to overall reliability or safety. Risk analyses are then used to apply informed design enhancements based on their contribution to risk reduction. A recent application of RID was the Altair Lunar Lander Project that was intended for human lunar exploration under NASA’s Constellation Program. The Altair project’s approach and results are reviewed and analyzed in this paper as a specific application of RID. In traditional projects, several tools such as Relex, Windchill or SAPHIRE, are used in parallel to apply risk informed design techniques. These analyses also traditionally occur later in the design cycle when changes are more difficult to implement. Safety and reliability analyses typically have no direct connection with the system architecture model, which accurately depicts the physical and functional constructs of a system, including the “ilities.” The model is directly impacted by the results of the analyses. This creates a time-consuming iterative process of analyses and modification because of the need to integrate several tools and teams. To improve this process, the research described here investigated the use of a single, cloud-based MBSE CAD tool called Innoslate that integrates failure analysis into the system architecture model. The specific focus of the research was on the analysis of system failure events through the use of a system architecture-modeling tool and the establishment of an MBSE process that enables system engineers to make risk-informed system modifications during development. The conclusion of the research was that MBSE in general, and Innoslate specifically, is capable of providing an integrated, effective and quantitative means of developing a risk-informed system design using a minimum functionality baseline process. This can be applied to human and robotic spaceflight systems and other systems with similar complexity. The research demonstrated that random distributions could be added to failure probabilities in order to add “noise” to the results, a task that can be laborious, if not impossible, if performed using a calculator or spreadsheet. The research also demonstrated an end-to-end MBSE process that was applied to a basic system model and the Altair Project. Recommendations for future work conclude the paper.

PSE and business decision-making in the chemical engineering curriculum

Integrated Process and Controller Design Software Tool – ProCACD

Systems Engineering Methods and Tools

Health information provides the foundation for all decision making in healthcare whether clinical at the bed side, or at a national government level. This information is generally collected as part of systems which support administrative or clinical workflow and practice. This chapter describes the many and varied features of systems such as electronic health records (EHRs), how they fit with health information systems and how they collectively manage information flow. Systems engineering methods and tools are described together with their use to suit the health industry. This focuses on the need for suitable system architectures and semantic interoperability. These concepts and their relevance to the health industry are explained. The relationship and requirements for appropriate data governance in these systems is also considered.

Life cycle assessment (LCA) methodology is a well-established analytical method to quantify environmental impacts, which has been mainly applied to products. However, recent literature would suggest that it has also the potential as an analysis and design tool for processes, and stresses that one of the biggest challenges of this decade in the field of process systems engineering (PSE) is the development of tools for environmental considerations. This article attempts to give an overview of the integration of LCA methodology in the context of industrial ecology, and focuses on the use of this methodology for environmental considerations concerning process design and optimization. The review identifies that LCA is often used as a multi-objective optimization of processes: practitioners use LCA to obtain the inventory and inject the results into the optimization model. It also shows that most of the LCA studies undertaken on process analysis consider the unit processes as black boxes and build the inventory analysis on fixed operating conditions. The article highlights the interest to better assimilate PSE tools with LCA methodology, in order to produce a more detailed analysis. This will allow optimizing the influence of process operating conditions on environmental impacts and including detailed environmental results into process industry.

A framework for the design of sustainable multi-input second-generation biorefineries through process simulation: A case study for the valorization of lignocellulosic and starchy waste from the plantain agro-industry