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Journal articles on the topic 'Batch Manufacturing process'

Author: Grafiati

Published: 4 June 2021

Last updated: 5 February 2022

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1

Burcham, Christopher L., Alastair J. Florence, and Martin D. Johnson. "Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing." Annual Review of Chemical and Biomolecular Engineering 9, no. 1 (June 7, 2018): 253–81. http://dx.doi.org/10.1146/annurev-chembioeng-060817-084355.

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The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

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2

Xie, Xiangzhong, and René Schenkendorf. "Robust Process Design in Pharmaceutical Manufacturing under Batch-to-Batch Variation." Processes 7, no. 8 (August 3, 2019): 509. http://dx.doi.org/10.3390/pr7080509.

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Model-based concepts have been proven to be beneficial in pharmaceutical manufacturing, thus contributing to low costs and high quality standards. However, model parameters are derived from imperfect, noisy measurement data, which result in uncertain parameter estimates and sub-optimal process design concepts. In the last two decades, various methods have been proposed for dealing with parameter uncertainties in model-based process design. Most concepts for robustification, however, ignore the batch-to-batch variations that are common in pharmaceutical manufacturing processes. In this work, a probability-box robust process design concept is proposed. Batch-to-batch variations were considered to be imprecise parameter uncertainties, and modeled as probability-boxes accordingly. The point estimate method was combined with the back-off approach for efficient uncertainty propagation and robust process design. The novel robustification concept was applied to a freeze-drying process. Optimal shelf temperature and chamber pressure profiles are presented for the robust process design under batch-to-batch variation.

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3

Stephanopoulos, George, Shahin Ali, Andreas Linninger, and Enrique Salomone. "Batch process development: From reactions to manufacturing systems." Computers & Chemical Engineering 23 (June 1999): S975—S984. http://dx.doi.org/10.1016/s0098-1354(99)80232-4.

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4

James, D. "Batch process automation." Manufacturing Engineer 85, no. 6 (December 1, 2006): 36–41. http://dx.doi.org/10.1049/me:20060604.

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5

Yu, Zhonghua. "ALGORITHM OF QUALITY CONTROL IN SMALL BATCH MANUFACTURING PROCESS." Chinese Journal of Mechanical Engineering 37, no. 08 (2001): 60. http://dx.doi.org/10.3901/jme.2001.08.060.

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6

Braglia, Marcello, Roberto Gabbrielli, and Francesco Zammori. "Consignment stock theory with a fixed batch manufacturing process." International Journal of Production Research 51, no. 8 (April 2013): 2377–98. http://dx.doi.org/10.1080/00207543.2012.740577.

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7

Yue, Ming Yue, and Yi Dan Zhou. "Progress of Theoretical Research-Oriented Multi-Species Small Batch Machining Process." Applied Mechanics and Materials 364 (August 2013): 470–73. http://dx.doi.org/10.4028/www.scientific.net/amm.364.470.

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With the rapid development of machinery manufacturing industry, multi variety and small batch production has gradually become one of the main means of manufacturing enterprises. On the basis of describing the characteristics and meaning of multi variety and small batch production, this article summarizes its domestic and international situation of machinery process theory, optimization and evaluation methods, presents several methods of mathematical description and model for multi variety and small batch production and finally summarize the trends of matching problem between the processing technology and production system.

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8

Taga (Sapunaru), Olga Valerica, Claudia Irina Koncsag, Cosmin Jinescu, and Alina Monica Mares. "Simulation and Optimization of Isopropyl Lactate Manufacturing Process." Revista de Chimie 70, no. 9 (October 15, 2019): 3335–37. http://dx.doi.org/10.37358/rc.19.9.7544.

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The new chemical processes are investigated in laboratory, usually in batch, with pure reactants, and specific laboratory methods applied for the purification of the products. Scaling-up processes means passing from batch to continuous process, using feed with impurificators, industrial equipment for separation and recirculation or purge for an economic operation with special care for safety and environment. This is why, following a study in laboratory for isopropyl lactate obtaining by transesterification in reactive distillation system, a flowsheet of the industrial process was proposed in this paper. Simulations of the transesterification process were performed. The purpose of these simulations has been to find the optimum solution from energy consumption point of view. Optimum parameters of the reactive distillation were found: the molar ratio isopropanol/methyl lactate R= 1.06, the number of theoretical stages in the distillation zone NTS=2.4 and the reflux ratio RR=2, in a process that produces 1.3 t/h IPL of 96% wt purity.

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9

Yuan, Hong Liang, Ai Min Wang, and Jin Fan Lei. "Job-Shop Manufacturing Execution Process Monitoring Technology." Advanced Materials Research 421 (December 2011): 483–88. http://dx.doi.org/10.4028/www.scientific.net/amr.421.483.

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According to the production characteristics of single piece and small batch production and the combination of production and research in aerospace workshops, this thesis has made an in-depth study of job-shop manufacturing execution process monitoring technology with strong adaptability. A model for visual manufacturing process monitoring based on process route was proposed, it realizes the job-shop production featured by entire staff participation, entire process management and omnibearing warranty.

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10

Singhal, S., B. Elkhatib, J. Stuber, S. V. Sreenivasan, and O. A. Ezekoye. "Characterization of Wet Batch Cleaning Process in Advanced Semiconductor Manufacturing." IEEE Transactions on Semiconductor Manufacturing 22, no. 3 (August 2009): 399–408. http://dx.doi.org/10.1109/tsm.2009.2026321.

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11

De Vin, L. J., J. De Vries, and Ton Streppel. "Process planning for small batch manufacturing of sheet metal parts." International Journal of Production Research 38, no. 17 (November 2000): 4273–83. http://dx.doi.org/10.1080/00207540050205082.

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12

Last, Mark, Guy Danon, Sholomo Biderman, and Eli Miron. "Optimizing a batch manufacturing process through interpretable data mining models." Journal of Intelligent Manufacturing 20, no. 5 (July 12, 2008): 523–34. http://dx.doi.org/10.1007/s10845-008-0148-7.

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13

Yadav, Vikramaditya G. "Keeping it simple: A higher-yielding process for manufacturing dendritic cells." Science Translational Medicine 11, no. 517 (November 6, 2019): eaaz9749. http://dx.doi.org/10.1126/scitranslmed.aaz9749.

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14

Terzea, Elena Loredana, Antonia Cristina Barascu, and Iulian Razvan Soare. "Lean Solutions in Batch Manufacturing Process with Applicability in Bumpers Production." Applied Mechanics and Materials 834 (April 2016): 205–10. http://dx.doi.org/10.4028/www.scientific.net/amm.834.205.

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Batch processes includes paint manufacturing, food processing, pharmaceutical industry, etc. The paper focuses on the process of paint manufacturing. The main contribution is the design of the current value stream mapping, very useful to understand the causes of waste and lead-time. This paper points out the necessity of applying lean methods within automotive industry, sector of bumpers painting and assembly, based on a real case-study.

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15

Morris, Raymond A., and Edward F. Watson. "DETERMINING PROCESS CAPABILITY IN A CHEMICAL BATCH PROCESS." Quality Engineering 10, no. 2 (November 1997): 389–96. http://dx.doi.org/10.1080/08982119708919147.

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16

Helgers, Heribert, Axel Schmidt, Lara Julia Lohmann, Florian Lukas Vetter, Alex Juckers, Christoph Jensch, Mourad Mouellef, Steffen Zobel-Roos, and Jochen Strube. "Towards Autonomous Operation by Advanced Process Control—Process Analytical Technology for Continuous Biologics Antibody Manufacturing." Processes 9, no. 1 (January 18, 2021): 172. http://dx.doi.org/10.3390/pr9010172.

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Continuous manufacturing opens up new operation windows with improved product quality in contrast to documented lot deviations in batch or fed-batch operations. A more sophisticated process control strategy is needed to adjust operation parameters and keep product quality constant during long-term operations. In the present study, the applicability of a combination of spectroscopic methods was evaluated to enable Advanced Process Control (APC) in continuous manufacturing by Process Analytical Technology (PAT). In upstream processing (USP) and aqueous two-phase extraction (ATPE), Raman-, Fourier-transformed infrared (FTIR), fluorescence- and ultraviolet/visible- (UV/Vis) spectroscopy have been successfully applied for titer and purity prediction. Raman spectroscopy was the most versatile and robust method in USP, ATPE, and precipitation and is therefore recommended as primary PAT. In later process stages, the combination of UV/Vis and fluorescence spectroscopy was able to overcome difficulties in titer and purity prediction induced by overlapping side component spectra. Based on the developed spectroscopic predictions, dynamic control of unit operations was demonstrated in sophisticated simulation studies. A PAT development workflow for holistic process development was proposed.

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17

Bostijn, N., W. Dhondt, C. Vervaet, and T. De Beer. "PAT-based batch statistical process control of a manufacturing process for a pharmaceutical ointment." European Journal of Pharmaceutical Sciences 136 (August 2019): 104946. http://dx.doi.org/10.1016/j.ejps.2019.05.024.

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18

Gros, Sebastien. "Dual-Mode Batch-to-Batch Optimization as a Markov Decision Process." Industrial & Engineering Chemistry Research 58, no. 30 (March 28, 2019): 13780–91. http://dx.doi.org/10.1021/acs.iecr.8b06471.

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19

Frade, Verônica M. F., Attilio Converti, Saleh Al Arni, Milena F. Silva, and Mauri S. A. Palma. "Batch and Fed-Batch Degradation of Enrofloxacin by the Fenton Process." Chemical Engineering & Technology 40, no. 4 (March 14, 2017): 663–69. http://dx.doi.org/10.1002/ceat.201600146.

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20

Kamel, Khaled, and Eman Kamel. "PLC Batch Process Control Design and Implementation Fundamentals." September 2020 2, no. 3 (June 9, 2020): 155–61. http://dx.doi.org/10.36548/jei.2020.3.001.

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Batch process control is typically used for repeated chemical reaction tasks. It starts with a measured liquid material filling operations followed by a controlled reaction leading to the discharge or transport of processed quantities of material. The input materials is contained in vessel reactor and subjected to a sequence of processing activities over a recipe predefined duration of time. Batch systems are designed to measure, process, and discharge a varying volume of liquid from drums, tanks, reactors, or other large storage vessel using a programmable logic controller (PLC). These systems are common in pharmaceutical, chemical packaging, Beverage processing, personal care product, biotech manufacturing, dairy processing, soap manufacturing, and food processing industries. This paper briefly discusses the fundamental techniques used in specifying, designing, and implementing a PLC batch process control [1, 2]. A simplified batch process is used to illustrate key issues in designing and implementing such systems. In addition to the structured PLC ladder design; more focus is given to safety requirements, redundancy, interlocking, input data validation, and safe operation. The Allen Bradley (AB) SLC 500 PLC along with the LogixPro simulator are used to illustrate the concepts discussed in this paper. Two pumps are used to bring in material during the tank filling and a third pump is used to drain processed product. The three pumps are equipped with flow meters providing pulses proportional to the actual flow rate through the individual pipes. The tank material is heated to a predefined temperature duration followed by mixing for a set time before discharge. Batch control systems provides automated process controls, typically and universally using PLC’s networked to HMI’s and other data storage, analysis, and assessment computers. The overall system perform several tasks including recipe development and download, production scheduling, batch management and execution, equipment performance monitoring, inventory, production history and tracking functionalities. Flexible batch control systems are designed to accommodate smaller batches of products with greater requirements / recipes variation, efficiently and quickly. In addition to providing process consistency, continuous batch process control quality improvements are attained through the automatic collection and analysis of real-time reliable and accurate event performance data [3, 4].

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21

Jain, Santosh, Jin-Kuk Kim, and Robin Smith. "Process Synthesis of Batch Distillation Systems." Industrial & Engineering Chemistry Research 52, no. 24 (June 10, 2013): 8272–88. http://dx.doi.org/10.1021/ie400003p.

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22

Renbi, Abdelghani, Johan Carlson, and Jerker Delsing. "Impact of PCB Manufacturing Process Variations on Trace Impedance." International Symposium on Microelectronics 2011, no. 1 (January 1, 2011): 000891–95. http://dx.doi.org/10.4071/isom-2011-tha1-paper3.

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This paper demonstrates statistically the impact of PCB manufacturing variations on the characteristic impedance. Moreover, it shows that the characteristics of the PCBs vary across different suppliers. These differences cannot be tolerated in some applications where the characteristic impedance is restricted to be within a specific range. We sampled 3 × 20 PCBs, each batch of twenty is ordered from a different manufacturer. The sampling consist of measuring the phase shift between the reected and the incident signals when injecting a 180 MHz sinewave into a PCB trace. The trace is selected to be the same for all samples. All the PCBs are ordered to be identical and designed for 50 Ω devices. Our conclusion was drawn after running the T-tests to assess statistically the significance of the difference occurring between the PCBs. Based on the computed P-values all the three batches are different from each other in the mean of the measured phase shift with 95 % confidence. The difference between the measured and the expected characteristic impedance is found as 3 %, 10 % and 20 % for these three manufacturers. We also witnessed board-to-board variations even within the same batch and from the same supplier due to the process instability by looking at the probability density of having the same phase shift that is equal to the mean. Some samples shown 2.6 % to 3.5 % difference above the mean.

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23

Tao, Li Yan, Man Zhang, and Zu Da Li. "Study on the Product Quality Control in Small Batch Trial Process." Advanced Materials Research 694-697 (May 2013): 3507–11. http://dx.doi.org/10.4028/www.scientific.net/amr.694-697.3507.

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An Analytic Hierarchy Process (AHP) method was used to determine the key process in small batch trial process. Combining with the historical data of the key process in the product manufacturing process, similarity theory and data transformation methods, the data capacity relating to the product quality characteristics were enlarged. Through drawing a control chart of the process, the quality control in small batch trial process was realized.

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24

He, Fa Jiang, Ming Hong Wang, and Yue Wang. "Study of Statistical Process Control for Multi Specification and Small Batch Production Based on Group Technology." Advanced Materials Research 219-220 (March 2011): 713–17. http://dx.doi.org/10.4028/www.scientific.net/amr.219-220.713.

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For the multi specification and small batch productions, because of small batch and short manufacture cycle of product, it is difficulty to get enough sample data used for setup control chart to Statistical Process Control (SPC) of manufacture process quality by traditional SPC method. A new part code system based on OPTIZ code system is proposed by coding parts, manufacturing processes and qualities according to Group Technology (GT) based on similarity theory, so characteristics of parts, manufacturing processes and qualities are transformed to code, analyzed and judged by similarity theory to enlarge sample data, to realize SPC by control chart method. A SPC program for multi specification and small batch production based on group technology is developed by Visual Basic software and verified by actual example.

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25

Mihok, Jozef, Jaroslava Kádárová, Michal Demečko, and Martin Ružinský. "The Use of SMED in Engineering Manufacturing." Applied Mechanics and Materials 816 (November 2015): 568–73. http://dx.doi.org/10.4028/www.scientific.net/amm.816.568.

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To survive in such an increasingly competitive world, there is a need of continuous improvement in every type of industry. An answer to these challenges for manufacturing companies is the implementation of lean concepts. The importance of short changeover times, SMED, has always been critical for manufacturing companies. It is one of the many lean production methods for reducing waste in the manufacturing process. It's a quick and effective way adjustment process of the actual product to another product. The practical part is focused on usage of SMED in manufacturing. Project was realized in engineering company oriented on machining heavy products. Separating time to external and internal we saved about 10% of total production time. The result is proposal timetable of standard changeover process. Also timetable of two pieces in batch, because insertion two pieces in the batch reduced the total time of production. Total time was reduced of two changeovers.

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26

Choi, Sang Wook, Julian Morris, and In-Beum Lee. "Dynamic model-based batch process monitoring." Chemical Engineering Science 63, no. 3 (February 2008): 622–36. http://dx.doi.org/10.1016/j.ces.2007.09.046.

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27

Uhlenbrock, Lukas, Christoph Jensch, Martin Tegtmeier, and Jochen Strube. "Digital Twin for Extraction Process Design and Operation." Processes 8, no. 7 (July 17, 2020): 866. http://dx.doi.org/10.3390/pr8070866.

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Traditional extraction processes of natural product are widespread, especially in regulated industries. Possibilities of extraction development and manufacturing optimization in regulated industries is limited. Regulatory approvals are often based on traditional preparations of phyto-pharmaceuticals. The dependence on traditional processes can result in sub-optimal extraction parameters causing unnecessary costs and product variability. Innovative methods like Quality-by-Design (QbD), including process analytical technology (PAT), open opportunities for manufacturers to cope with regulatory demanded, narrow batch-to-batch variability. In addition, such validated process models represent perfect digital twins which could be utilized for advanced process control and life cycle analysis.

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28

Scherwitz, Philipp, Steffen Ziegler, and Johannes Schilp. "Process Mining in der additiven Auftragsabwicklung/Process Mining for additive manufacturing." wt Werkstattstechnik online 110, no. 06 (2020): 429–34. http://dx.doi.org/10.37544/1436-4980-2020-06-69.

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Die Fähigkeit der additiven Fertigung in Losgröße 1 zu fertigen, erzeugt eine hohe Komplexität in der Auftragsabwicklung. Dies stellt die datenbasierte Optimierung der Prozessabläufe vor große Herausforderungen. Durch die geringen Stückzahlen, bei einer hohen Variantenanzahl, ist die Prozessaufnahme in der additiven Fertigung mit signifikanten Aufwänden verbunden. Abhilfe kann hier eine automatisierte Prozessaufnahme schaffen. Deshalb soll in diesem Beitrag die Technologie des Process Mining untersucht und darauf aufbauend eine Vorgehensweise für die datenbasierte Optimierung in der additiven Fertigung vorgestellt werden.   The capability of additive manufacturing to produce in batch size 1 creates a high degree of complexity in order processing. This creates great challenges for the data-based optimization of process flows. Due to the low number of pieces, with a high number of variants, the process recording in additive manufacturing is connected with significant expenditures. This can be overcome by automated process recording. Therefore, this article will examine the technology of process mining and, based on this, present a procedure for data-based optimization in additive manufacturing.

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29

Chen, X., F. Chen, and L. Yin. "Anomaly Detection of Manufacturing Process for Multi-Variety and Small Batch Production." Journal of Physics: Conference Series 1487 (March 2020): 012007. http://dx.doi.org/10.1088/1742-6596/1487/1/012007.

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30

Tian, Wenxing, Hailong You, Kai Gu, Chunfu Zhang, and Xinzhang Jia. "Two-Level Nested Control Chart for Batch Process in the Semiconductor Manufacturing." IEEE Transactions on Semiconductor Manufacturing 29, no. 4 (November 2016): 399–410. http://dx.doi.org/10.1109/tsm.2016.2603997.

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31

Miao, Rui, Xinyi Zhang, Sike Li, and Zhibin Jiang. "Part dimension deviation control in batch manufacturing process for monitoring error sources." International Journal of Production Research 51, no. 8 (April 2013): 2518–26. http://dx.doi.org/10.1080/00207543.2012.740578.

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32

Wang, Kaibo, and Kai Han. "A batch-based run-to-run process control scheme for semiconductor manufacturing." IIE Transactions 45, no. 6 (June 2013): 658–69. http://dx.doi.org/10.1080/0740817x.2012.757681.

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33

Palaniswami, Shanthakumar. "Simulating the impact of process capability on lot sizes in batch manufacturing." International Journal of Production Economics 26, no. 1-3 (February 1992): 203–10. http://dx.doi.org/10.1016/0925-5273(92)90064-e.

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34

Zhang, Jie. "Batch-to-batch optimal control of a batch polymerisation process based on stacked neural network models." Chemical Engineering Science 63, no. 5 (March 2008): 1273–81. http://dx.doi.org/10.1016/j.ces.2007.07.047.

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35

Krennrich, G. "Multivariate Methods for Process Data Analysis - A Batch Process Application." Chemical Engineering & Technology 24, no. 12 (December 2001): 1235–38. http://dx.doi.org/10.1002/1521-4125(200112)24:12<1235::aid-ceat1235>3.0.co;2-f.

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36

Feng, An Ping. "Application Research of Numerical Control Machining Technology in Mechanical Manufacturing." Advanced Materials Research 898 (February 2014): 521–24. http://dx.doi.org/10.4028/www.scientific.net/amr.898.521.

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Mold manufacturing is an important part in mechanical manufacturing, and casting quality of mechanical manufacturing is influenced by mold quality directly. If mold manufacturing still adopts the traditional mode, that will has a severe dependence on core box or appearance, often with a relatively long period and relatively high cost, which will be hard to satisfy the rapid development and manufacturing of small batch sheet parts. This article introduces the application of new product development, processing equipment performance and process principle of metal parts no-mode numerical control processing and manufacturing technology, the technology in mechanical manufacturing process. This technology is to thoroughly change the traditional craft with no need of modes, and is able to cast accurate and quick production. Its main characteristics are flexible, digital, greening, motors, etc., which provide the corresponding solutions for rapid manufacture small batch sheet metal.

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37

GILBERT, STEPHEN, and HAMILTON EMMONS. "Managing a deteriorating process in a batch production environment." IIE Transactions 27, no. 2 (April 1995): 233–43. http://dx.doi.org/10.1080/07408179508936736.

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38

Hu, Kunlun, and Jingqi Yuan. "Batch process monitoring with tensor factorization." Journal of Process Control 19, no. 2 (February 2009): 288–96. http://dx.doi.org/10.1016/j.jprocont.2008.03.003.

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39

Adonyi, R., J. Romero, L. Puigjaner, and F. Friedler. "Incorporating heat integration in batch process scheduling." Applied Thermal Engineering 23, no. 14 (October 2003): 1743–62. http://dx.doi.org/10.1016/s1359-4311(03)00141-8.

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40

Foo, Dominic Chwan Yee. "Automated Targeting Technique for Batch Process Integration." Industrial & Engineering Chemistry Research 49, no. 20 (October 20, 2010): 9899–916. http://dx.doi.org/10.1021/ie100146n.

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41

Zobel, Tobias, Bernd Groß, Georg Fieg, and G. Wozny. "Integral Optimization of an Industrial Batch Process." Chemie Ingenieur Technik 73, no. 6 (June 2001): 631–32. http://dx.doi.org/10.1002/1522-2640(200106)73:6<631::aid-cite6313333>3.0.co;2-s.

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42

Hu, Chuntian, Christopher J. Testa, Stephen C. Born, Wei Wu, Khrystyna Shvedova, Ridade Sayin, Bhakti S. Halkude, et al. "E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals." Green Chemistry 22, no. 13 (2020): 4350–56. http://dx.doi.org/10.1039/d0gc01397h.

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43

Aleksievska Beldedovska, Katerina, Jelena Acevska, Aneta Dimitrovska, and Miroslava Ilievska. "Challenges of manufacturing site in batch certification and release in European Union." Macedonian Pharmaceutical Bulletin 65, no. 2 (2019): 3–9. http://dx.doi.org/10.33320/maced.pharm.bull.2019.65.02.001.

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A comprehensively designed Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice and Quality Risk Management implemented, maintained and continuously improved, allows a consistent delivery of products with appropriate quality attributes. The manufacturer in the third country and the batch certification and release site in EU belong to the same organization operating under a corporate Pharmaceutical Quality System. A signed Quality Agreement between both parties provides improvement of the Pharmaceutical Quality System and continual maintenance of the quality of the medicinal product throughout its shelf life. This paper outlines the role and the challenges of the manufacturing site in third country within the process of batch certification and release in EU (by EU QP) and also highlights the importance of the technically justified approach including Quality Risk Management process regarding sampling in third country. Through a Technical justification for sampling including Quality Risk Assessment, it is considered that the samples taken from the manufacturing site in third country ensure representation of the whole batch. Technical justification is performed periodically to identify and manage any risks associated with this approach, thus ensuring the quality, safety and efficacy according Marketing Authorization. Keywords: batch release in EU, third country, Pharmaceutical Quality System, QP

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44

Ao, Tang, Xiao Dong, and Mao Zhizhong. "Batch-to-Batch Iterative Learning Control of a Batch Polymerization Process Based on Online Sequential Extreme Learning Machine." Industrial & Engineering Chemistry Research 48, no. 24 (December 16, 2009): 11108–14. http://dx.doi.org/10.1021/ie9007979.

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45

Pourali, O., M. Amidpour, and D. Rashtchian. "Time decomposition in batch process integration." Chemical Engineering and Processing: Process Intensification 45, no. 1 (January 2006): 14–21. http://dx.doi.org/10.1016/j.cep.2005.06.002.

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46

Kornecki, Martin, and Jochen Strube. "Accelerating Biologics Manufacturing by Upstream Process Modelling." Processes 7, no. 3 (March 21, 2019): 166. http://dx.doi.org/10.3390/pr7030166.

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Intensified and accelerated development processes are being demanded by the market, as innovative biopharmaceuticals such as virus-like particles, exosomes, cell and gene therapy, as well as recombinant proteins and peptides will possess no available platform approach. Therefore, methods that are able to accelerate this development are preferred. Especially, physicochemical rigorous process models, based on all relevant effects of fluid dynamics, phase equilibrium, and mass transfer, can be predictive, if the model is verified and distinctly quantitatively validated. In this approach, a macroscopic kinetic model based on Monod kinetics for mammalian cell cultivation is developed and verified according to a general valid model validation workflow. The macroscopic model is verified and validated on the basis of four decision criteria (plausibility, sensitivity, accuracy and precision as well as equality). The process model workflow is subjected to a case study, comprising a Chinese hamster ovary fed-batch cultivation for the production of a monoclonal antibody. By performing the workflow, it was found that, based on design of experiments and Monte Carlo simulation, the maximum growth rate µmax exhibited the greatest influence on model variables such as viable cell concentration XV and product concentration. In addition, partial least squares regressions statistically evaluate the correlations between a higher µmax and a higher cell and product concentration, as well as a higher substrate consumption.

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Nawanir, Gusman, Kong Teong Lim, T. Ramayah, Fatimah Mahmud, Khai Loon Lee, and Mohd Ghazali Maarof. "Synergistic effect of lean practices on lead time reduction: mediating role of manufacturing flexibility." Benchmarking: An International Journal 27, no. 5 (April 23, 2020): 1815–42. http://dx.doi.org/10.1108/bij-05-2019-0205.

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Abstract:

PurposeThis study scrutinized the synergistic effects of lean manufacturing (LM) on lead time reduction (LR) while investigating the mediating role of manufacturing flexibility (MF) in that relationship within the context of batch and mass customization manufacturers.Design/methodology/approachThis cross-sectional survey involved 160 large batch and mass customization manufacturers in Indonesia. Data were analyzed by using the PLS path modeling approach and multigroup analysis.FindingsThe positive synergistic direct effects of LM on LR and MF were revealed in both process types. In mass customization, MF mediates the effect of LM on LR. However, such a mediating effect was not found in the batch process due to the insignificant effect of MF on LR.Practical implicationsThe findings offered theoretical and practical insights supporting the manufacturers to grasp potential benefits through the holistic LM implementation as well as the suitable strategies to improve MF and reduce lead time by considering the types of the production process.Originality/valueThis study bridged the gaps regarding the comparison of LM implementation and its influence on MF and LR in mass customization and batch production.

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LI, Gang, and Hai-fei DAI. "Modeling method of multivariate statistical control chart for small-batch manufacturing process quality." Journal of Computer Applications 28, no. 10 (September 30, 2009): 2718–20. http://dx.doi.org/10.3724/sp.j.1087.2008.02718.

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Holzberg, Timothy R., Valencia Watson, Sheniqua Brown, Abhay Andar, Xudong Ge, Yordan Kostov, Leah Tolosa, and Govind Rao. "Sensors for biomanufacturing process development: facilitating the shift from batch to continuous manufacturing." Current Opinion in Chemical Engineering 22 (December 2018): 115–27. http://dx.doi.org/10.1016/j.coche.2018.09.008.

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Lenderink, A., and H. J. J. Kals. "The integration of process planning and machine loading in small batch part manufacturing." Robotics and Computer-Integrated Manufacturing 10, no. 1-2 (January 1993): 89–98. http://dx.doi.org/10.1016/0736-5845(93)90030-n.

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