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Introduction Commercially Available Simulation and Scheduling Tools Modeling and Analysis of an API Manufacturing Process Uncertainty and Variability Analysis Production Scheduling Capacity Analysis and Production Planning Summary References
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... a selling price of $450/kg, the project yields an after-tax internal rate of return (IRR) of 14% and a net present value (NPV) of $8.5 million (assuming a discount interest of 7%). Figure 6 breaks down the manufacturing cost. The facility-dependent cost, which primarily accounts for the depreciation and maintenance of the plant, is the most important item accounting for 35.74% of the overall cost. ...
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Citations
... The role of such tools in the development and manufacturing of APIs has been reviewed in the past. [1][2][3][4][5][6][7] This article focuses on the role of such tools in the development and manufacture of pharmaceutical products that require fill-finish. During process development and facility design, simulation tools facilitate analysis tasks that include the following: ...
This article presents examples and methodologies for optimizing the design and operation of fill-finish facilities using process simulation and scheduling tools.
The plantain agro-industry generates different residues in the harvest and post-harvest stages. Therefore, new processes for its valorization are required. The aim of this research was to propose a general methodological framework for the design and analysis of multi-input biorefineries for the valorization of residues with a high content of lignocellulosic and starchy materials. This approach was based on the independent processing of the starchy and lignocellulosic materials in the first steps of the biorefinery and relies on process simulation and hierarchic process design procedures. A case study for the design of a multi-input biorefinery for the valorization of residues from the plantain agro-industry was performed by applying the framework proposed. The biorefinery was simulated using SuperPro Designer software. The results obtained suggest that the best alternative for the valorization of plantain residues under Colombian conditions corresponded to the following distribution of key residues: 100% leaf sheaths processed into the natural fiber production section, and 25% peels and 25 % rachis processed into the starch extraction and liquefaction section; with this distribution, an NPV of $21,348,000 can be achieved. This work shows that waste from the plantain agro-industry exhibits high potential as a feedstock for the production of value-added products.
The aim of this work was to evaluate the production of isomalto–oligosaccharides (IMO) from rejected unripe plantain fruits (Musa AAB Simmonds) on a laboratory scale and assess IMO syrup production for a large scale through process simulation. The enzymatic activity of the commercial preparation of α-glucosidase was 936.23 ± 0.71 U/mL. The Michaelis–Menten model was used to adjust the experimental data, and its kinetic parameters were used in the simulation. Maximum IMO production from a mixture of 18% plantain flour with a starch content of 84% was obtained for a reaction of 6 h in the transglycosylation step (29 ± 3 g/L isomaltotetraose and 8 ± 3 g/L isomaltopentaose). The best scenario to produce IMO showed a net present value of $ 459,000. Results suggest that IMO syrup production for a large scale, including an integrated production of single cell protein considering a batch size greater than 11,126 kg rejected fruits is feasible, if the production costs associated with labor are reduced and the selling price of the products increases according to the variation of the market. This work demonstrated that the rejected plantain pulp exhibits high potential as an ingredient to produce prebiotic compounds such as IMO.
This chapter addresses the challenges of evaluating the business case for continuous manufacturing of pharmaceuticals, looking beyond traditional technical assessments made at the unit operations or individual production facility level. It provides an overview of key concepts, approaches, and tools for the early assessment of supply network configuration opportunities enabled by continuous production processing interventions. Multiple levels of analysis are considered with the aid of examples based on major UK research programs on continuous production process technologies. Particular emphasis is placed on the potential for achieving enhanced product flexibility (in terms of volume and variety) and, depending on scale, the optimum number and location of manufacturing operations to support speed to market and system-level cost benefits. In the case of multiple manufacturing operations using continuous production process technologies, where production facility replication through digital twins is becoming a key enabler, the chapter sets out a supply network design and analysis approach that evaluates the commercial and operational viability of alternative manufacturing supply network scenarios.
Sequential model-based A- and V-optimal experimental designs are known to be effective for maximizing the information content of data, leading to reliable parameter estimates and model predictions. A- and V-optimal designs require inversion of the Fisher Information Matrix (FIM), which may be noninvertible especially for fundamental models with many parameters. In this study, two different methodologies for selecting sequential approximately A- and V-optimal experiments are compared for situations where the FIM is noninvertible. The first approach, called Leave Out (LO) approach, finds and leaves out problematic parameters that make the FIM noninvertible and the second approach, called Pseudoinverse (PI) approach, uses a Moore-Penrose pseudoinverse of the FIM. Comparisons are carried out using a Michaelis Menten reaction dynamic model for production of a pharmaceutical agent. Monte Carlo simulations indicate, for both A- and V-optimal situations, that designed experiments using the LO approach are superior to designs obtained by the PI approach.
Transformation of organic waste to energy is a complex process which involves hundreds of possible intermediate compounds and reactions. Simulation process can provide suitable assessment of a bioconversion system before its actual fabrication and commercialization. In addition, process simulation is a suitable tool for optimization of technical factors (e.g., bioreactor configuration and conversion units design) and economical factors (e.g., throughput, production cost, revenue and gross margin). In this study, biodegradation process of a small-scale anaerobic bioreactor was simulated using SuperPro Designer®. Process simulation flow sheet, materials registration and process reactions were conducted during model setup. Next, model validation was carried out by comparison between the outputs and actual data achieved during experimental phase. Results show the appreciable agreement between predicted and actual data due to appropriate process definition during simulation. Two different bioreactor configurations were investigated and efficiency and performance of each pattern was tested based on biogas production rate, methane content in biogas and biochemical and chemical oxygen demands (BOD and COD) removal efficiencies. Finally, economical analysis was performed in the model which indicates, biogas production from organic waste in a single small-scale bioreactor is a promising method for renewable energy generation.
