skip to main content
10.1145/3494583.3494641acmotherconferencesArticle/Chapter ViewAbstractPublication PagesicibeConference Proceedingsconference-collections
research-article

The Transition from Batch to Continuous Manufacturing for Tablet Manufacturing

Published: 09 January 2022 Publication History

Abstract

Challenges and opportunities lie in the road of transition from batch to continuous tablet manufacturing. The complexity of the continuous manufacturing process demonstrates the large improvement space. This paper provided an overview of the current stage of the transition from batch manufacturing to continuous manufacturing. This paper studied one novel systematic framework proposed by a research team to implement material traceability into continuous tablet manufacturing. The application in MATLAB showed the successful implementation of the framework into the continuous manufacturing process. Areas of improvement are also put forward in the paper to shed some light on the future directions to improve material traceability and the overall continuous manufacturing process.

References

[1]
Billups, M.; Singh, R. Systematic Framework for Implementation of Material Traceability into Continuous Pharmaceutical Tablet Manufacturing Process. Journal of pharmaceutical innovation, 2020, 15, 51-65.
[2]
Hock, S. C.; Siang, T. K.; Wah, C. L. Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators. GaBI Journal, 2021, 10, 44-56.
[3]
Van Snick, B.; Kumar, A.; Verstraeten, M.; Pandelaere, K.; Dhondt, J.; Di Pretoro, G.; De Beer, T.; Vervaet, C.; Vanhoorne, V. Impact of material properties and process variables on the residence time distribution in twin screw feeding equipment. International Journal of Pharmaceutics, 2019, 556, 200-216.
[4]
Zimmermann, M.; Thommes, M. Residence time and mixing capacity of a rotary tablet press feed frame. Drug development and industrial pharmacy, 2021, 47, 790-798.
[5]
Martinetz, M. C.; Karttunen, A.; Sacher, S.; Wahl, P.; Ketolainen, J.; Khinast, J. G.; Korhonen, O. RTD-based material tracking in a fully-continuous dry granulation tableting line. International Journal of Pharmaceutics, 2018, 547, 469-479.
[6]
Peterwitz, M.; Schembecker, G. Evaluating the potential for optimisation of axial back-mixing in continuous pharmaceutical manufacturing. Computers & Chemical Engineering, 2021, 147, 107251.
[7]
Tian, G.; Koolivand, A.; Arden, N. S.; Lee, S.; O'Connor, T. F. Quality risk assessment and mitigation of pharmaceutical continuous manufacturing using flowsheet modeling approach. Computers & Chemical Engineering, 2019, 129, 106508.
[8]
Destro, F.; Hur, I.; Wang, V.; Abdi, M.; Feng, X.; Wood, E.; Coleman, S.; Firth, P.; Barton, A.; Barolo, M.; Nagy, Z. K. Mathematical modeling and digital design of an intensified filtration-washing-drying unit for pharmaceutical continuous manufacturing. Chemical Engineering Science, 2021, 244, 116803.
[9]
Galbraith, S. C.; Cha, B.; Huang, Z.; Park, S.; Liu, H.; Meyer, R. F.; Flamm, M. H.; Hurley, S.; Zhang-Plasket, F.; Yoon, S. Integrated modeling of a continuous direct compression tablet manufacturing process: A production scale case study. Powder Technology, 2019, 354, 199-210.
[10]
Taipale-Kovalainen, K.; Karttunen, A.; Niinikoski, H.; Ketolainen, J.; Korhonen, O. The effects of unintentional and intentional process disturbances on tablet quality during long continuous manufacturing runs. European Journal of Pharmaceutical Sciences, 2019, 129, 10-20.
[11]
Yadav, I. K.; Holman, J.; Meehan, E.; Tahir, F.; Khoo, J.; Taylor, J.; Benedetti, A.; Aderinto, O.; Bajwa, G. Influence of material properties and equipment configuration on loss-in-weight feeder performance for drug product continuous manufacture. Powder Technology, 2019, 348, 126-137.
[12]
Matsunami, K.; Nagato, T.; Hasegawa, K.; Sugiyama, H. Determining key parameters of continuous wet granulation for tablet quality and productivity: A case in ethenzamide. International Journal of Pharmaceutics, 2020, 579, 119160.
[13]
Shi, G.; Lin, L.; Liu, Y.; Chen, G.; Luo, Y.; Wu, Y.; Li, H. Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets. RSC Adv. 2021, 11, 8323-8345.
[14]
Kirchengast, M.; Celikovic, S.; Rehrl, J.; Sacher, S.; Kruisz, J.; Khinast, J.; Horn, M. Ensuring tablet quality via model-based control of a continuous direct compaction process. International Journal of Pharmaceutics 2019, 567, 118457.
[15]
Su, Q.; Ganesh, S.; Moreno, M.; Bommireddy, Y.; Gonzalez, M.; Reklaitis, G. V.; Nagy, Z. K. A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing. Computers & Chemical Engineering, 2019, 125, 216-231.
[16]
Rehrl, J.; Karttunen, A.; Nicolaï, N.; Hörmann, T.; Horn, M.; Korhonen, O.; Nopens, I.; De Beer, T.; Khinast, J. G. Control of three different continuous pharmaceutical manufacturing processes: Use of soft sensors. International Journal of Pharmaceutics, 2018, 543, 60-72.
[17]
Moreno, M.; Ganesh, S.; Shah, Y. D.; Su, Q.; Gonzalez, M.; Nagy, Z. K.; Reklaitis, G. V. Sensor Network Robustness Using Model-Based Data Reconciliation for Continuous Tablet Manufacturing. Journal of Pharmaceutical Sciences, 2019, 108, 2599-2612.
[18]
Kamyar, R.; Lauri Pla, D.; Husain, A.; Cogoni, G.; Wang, Z. Soft sensor for real-time estimation of tablet potency in continuous direct compression manufacturing operation. International Journal of Pharmaceutics, 2021, 602, 120624.
[19]
Su, Q.; Bommireddy, Y.; Shah, Y.; Ganesh, S.; Moreno, M.; Liu, J.; Gonzalez, M.; Yazdanpanah, N.; O'Connor, T.; Reklaitis, G. V.; Nagy, Z. K. Data reconciliation in the Quality-by-Design (QbD) implementation of pharmaceutical continuous tablet manufacturing. International Journal of Pharmaceutics, 2019, 563, 259-272.
[20]
Pauli, V.; Roggo, Y.; Pellegatti, L.; Nguyen Trung, N. Q.; Elbaz, F.; Ensslin, S.; Kleinebudde, P.; Krumme, M. Process analytical technology for continuous manufacturing tableting processing: A case study. Journal of Pharmaceutical and Biomedical Analysis, 2019, 162, 101-111.
[21]
Hetrick, E. M.; Shi, Z.; Harms, Z. D.; Myers, D. P. Sample Mass Estimate for the Use of Near-Infrared and Raman Spectroscopy to Monitor Content Uniformity in a Tablet Press Feed Frame of a Drug Product Continuous Manufacturing Process. Appl Spectrosc, 2021, 75, 216-224.
[22]
Barimani, S.; Šibanc, R.; Kleinebudde, P. Optimization of a semi-batch tablet coating process for a continuous manufacturing line by design of experiments. International Journal of Pharmaceutics, 2018, 539, 95-103.
[23]
Medendorp, J.; Shapally, S.; Vrieze, D.; Tolton, K. Process Control of Drug Product Continuous Manufacturing Operations—a Study in Operational Simplification and Continuous Improvement. Journal of Pharmaceutical Innovation, 2020.
[24]
Menth, J.; Maus, M.; Wagner, K. G. Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties. International Journal of Pharmaceutics, 2020, 586, 119509.
[25]
Razavi, S. M.; Scicolone, J.; Snee, R. D.; Kumar, A.; Bertels, J.; Cappuyns, P.; Van Assche, I.; Cuitiño, A. M.; Muzzio, F. Prediction of tablet weight variability in continuous manufacturing.
[26]
Cole, K. P.; Groh, J. M.; Johnson, M. D.; Burcham, C. L.; Campbell, B. M.; Diseroad, W. D.; Heller, M. R.; Howell, J. R.; Kallman, N. J.; Koenig, T. M.; May, S. A.; Miller, R. D.; Mitchell, D.; Myers, D. P.; Myers, S. S.; Phillips, J. L.; Polster, C. S.; White, T. D.; Cashman, J.; Hurley, D.; Moylan, R.; Sheehan, P.; Spencer, R. D.; Desmond, K.; Desmond, P.; Gowran, O. Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions. Science (American Association for the Advancement of Science), 2017, 356, 1144-1150.
[27]
Metta, N.; Ghijs, M.; Schäfer, E.; Kumar, A.; Cappuyns, P.; Assche, I. V.; Singh, R.; Ramachandran, R.; Beer, T. D.; Ierapetritou, M.; Nopens, I. Dynamic Flowsheet Model Development and Sensitivity Analysis of a Continuous Pharmaceutical Tablet Manufacturing Process Using the Wet Granulation Route. Processes, 2019, 7, 234.
[28]
Domokos, A.; Nagy, B.; Gyürkés, M.; Farkas, A.; Tacsi, K.; Pataki, H.; Liu, Y. C.; Balogh, A.; Firth, P.; Szilágyi, B.; Marosi, G.; Nagy, Z. K.; Nagy, Z. K. End-to-end continuous manufacturing of conventional compressed tablets: From flow synthesis to tableting through integrated crystallisation and filtration. International Journal of Pharmaceutics, 2020, 581, 119297.
[29]
Matsunami, K.; Nagato, T.; Hasegawa, K.; Sugiyama, H. A large-scale experimental comparison of batch and continuous technologies in pharmaceutical tablet manufacturing using ethenzamide. International Journal of Pharmaceutics, 2019, 559, 210-219.
[30]
Bostijn, N.; Van Renterghem, J.; Vanbillemont, B.; Dhondt, W.; Vervaet, C.; De Beer, T. Continuous manufacturing of a pharmaceutical cream: Investigating continuous powder dispersing and residence time distribution (RTD). European Journal of Pharmaceutical Sciences, 2019, 132, 106-117.
[31]
Escotet-Espinoza, M. S.; Scicolone, J. V.; Moghtadernejad, S.; Sanchez, E.; Cappuyns, P.; Van Assche, I.; Di Pretoro, G.; Ierapetritou, M.; Muzzio, F. J. Improving Feedability of Highly Adhesive Active Pharmaceutical Ingredients by Silication. Journal of pharmaceutical innovation, 2020, 16, 279.
[32]
Taipale-Kovalainen, K.; Ketolainen, J.; Korhonen, O.; Ervasti, T. Converting a batch based high-shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets. European journal of pharmaceutical sciences, 2020, 151, 105381.

Recommendations

Comments

Information & Contributors

Information

Published In

cover image ACM Other conferences
ICIBE '21: Proceedings of the 7th International Conference on Industrial and Business Engineering
September 2021
411 pages
ISBN:9781450390644
DOI:10.1145/3494583
Permission to make digital or hard copies of all or part of this work for personal or classroom use is granted without fee provided that copies are not made or distributed for profit or commercial advantage and that copies bear this notice and the full citation on the first page. Copyrights for components of this work owned by others than ACM must be honored. Abstracting with credit is permitted. To copy otherwise, or republish, to post on servers or to redistribute to lists, requires prior specific permission and/or a fee. Request permissions from [email protected]

Publisher

Association for Computing Machinery

New York, NY, United States

Publication History

Published: 09 January 2022

Permissions

Request permissions for this article.

Check for updates

Author Tags

  1. RTD
  2. batch manufacturing
  3. continuous manufacturing
  4. material traceability
  5. systematic framework

Qualifiers

  • Research-article
  • Research
  • Refereed limited

Conference

ICIBE 2021

Contributors

Other Metrics

Bibliometrics & Citations

Bibliometrics

Article Metrics

  • 0
    Total Citations
  • 79
    Total Downloads
  • Downloads (Last 12 months)10
  • Downloads (Last 6 weeks)1
Reflects downloads up to 05 Mar 2025

Other Metrics

Citations

View Options

Login options

View options

PDF

View or Download as a PDF file.

PDF

eReader

View online with eReader.

eReader

HTML Format

View this article in HTML Format.

HTML Format

Figures

Tables

Media

Share

Share

Share this Publication link

Share on social media