In Silico Process Optimization and Quality by Design with Business and Environmental Sustainability Considerations
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- 作者：Arief Adhitya ; Suat-Teng Tan ; Edwin Tan ; Wee Chew
- 关键词：Process analytical technology (PAT) ; Quality by design (QbD) ; Design of experiments (DoE) ; Process development ; Process optimization ; Epoxidation
- 刊名：Journal of Pharmaceutical Innovation
- 出版年：2017
- 出版时间：March 2017
- 年：2017
- 卷：12
- 期：1
- 页码：49-61
- 全文大小：
- 刊物主题：Pharmacology/Toxicology; Industrial and Production Engineering; Biotechnology; Biochemical Engineering;
- 出版者：Springer US
- ISSN：1939-8042
- 卷排序：12
文摘
PurposeIn designing pharmaceutical manufacturing alongside the principles of quality by design (QbD) and process analytical technology (PAT), unit operations process development and corporate decision-making processes such as business profits and environmental impact assessments are often undertaken separately. This paper presents a strategic three-tier framework linking the process, operations, and business/enterprise levels for process development and improvement alongside an in silico optimization approach.