Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

Wenhui Yang; Wuxi Qian; Zhihong Yuan; Bingzhen Chen

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Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

Review | Updated：2026-01-06

- Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes
- Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes
- 中国化学工程学报（英文版） 2022年41卷第1期页码：29-41
- Affiliations：
  
  1. State Key Laboratory of Chemical Engineering, Department of Chemical Engineering, Tsinghua University,Beijing,China,100084
  2. Department of Chemical Engineering, Tsinghua University,Beijing,China,100084
- Author bio：
- Funds：
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- 纸质出版：2022
- Accepted：
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Wenhui Yang, Wuxi Qian, Zhihong Yuan, 等. Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes[J]. 中国化学工程学报（英文版）, 2022,41(1):29-41.

Wenhui Yang, Wuxi Qian, Zhihong Yuan, Bingzhen Chen. Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes[J]. Chinese Journal of Chemical Engineering, 2022, 41(1): 29-41.
Wenhui Yang, Wuxi Qian, Zhihong Yuan, 等. Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes[J]. 中国化学工程学报（英文版）, 2022,41(1):29-41. DOI：

Wenhui Yang, Wuxi Qian, Zhihong Yuan, Bingzhen Chen. Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes[J]. Chinese Journal of Chemical Engineering, 2022, 41(1): 29-41. DOI：

摘要

Abstract

Pharmaceutical continuous manufacturing

especially under the context of COVID-19 pandemic

is regarded as an emerging technology that can guarantee the adequate quality assurance and mitigate process risk while guaranteeing the desirable economic performance. Flexibility analysis is one approach to quantitively assess the capability of chemical process to guarantee feasible operation in face of variations on uncertain parameters. The aim of this paper is to provide the perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes. State-of-the-art and progress in the flexibility analysis for chemical processes including concept evolution

mathematical model formulations

solution strategies

and applications are systematically overviewed. Recent achievements on the flexibility/feasibility analysis of the downstream dosage form manufacturing process are also touched upon. Further challenges and developments in the field of flexibility analysis for novel continuous manufacturing processes of active pharmaceutical ingredients along with the integrated continuous manufacturing processes are identified.

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