Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
Int J Pharm. 2022 Feb 5;613:121408. doi: 10.1016/j.ijpharm.2021.121408. Epub 2021 Dec 21.
The implementation of continuous pharmaceutical manufacturing requires advanced control strategies rather than traditional end product testing or an operation within a small range of controlled parameters. A high level of automation based on process models and hierarchical control concepts is desired. The relevant tools that have been developed and successfully tested in academic and industrial environments in recent years are now ready for utilization on the commercial scale. To date, the focus in Process Analytical Technology (PAT) has mainly been on achieving process understanding and quality control with the ultimate goal of real-time release testing (RTRT). This work describes the workflow for the development of an in-line monitoring strategy to support PAT-based real-time control actions and its integration into solid dosage manufacturing. All stages are discussed in this paper, from process analysis and definition of the monitoring task to technology assessment and selection, its process integration and the development of data acquisition.
连续制药生产的实施需要先进的控制策略，而不是传统的最终产品测试或在小范围控制参数内的操作。需要基于过程模型和分层控制概念的高度自动化。近年来，在学术和工业环境中开发并成功测试的相关工具现已准备好用于商业规模。迄今为止，过程分析技术 (PAT) 的重点主要是通过实时放行测试 (RTRT) 实现对工艺的理解和质量控制，以达到最终目的。这项工作描述了开发在线监测策略以支持基于 PAT 的实时控制措施的工作流程及其在固体制剂生产中的集成。本文讨论了从过程分析和监测任务定义到技术评估和选择、过程集成以及数据采集开发的所有阶段。
