Pharmaceutical manufacturing: automation of heat and mass transfer processes

即使最近取得了显著的进步，制药业的生产效率仍然落后于大多数其他行业。自动化和连续加工是提高竞争力的一种方式，可以减少生产时间、能源消耗和产生的废物量。事实上，更好的传感器和闭环反馈控制系统能够通过基于设计而不是基于测试的质量向更理想的质量过渡，从而生产下一代药品。它们还减少了过程的可变性和操作员的错误，并使人们更好地理解过程。目标是提高质量和热交换的三个过程的自动化程度：片剂涂层：开发一种提供薄膜涂层性能的在线视觉传感器（涂层水平，片剂间的美学缺陷分布等）。-颗粒的干燥（在压缩成片剂之前）：安全可靠的在线干燥时间和/或能量消耗最小化。-小瓶冷冻干燥：安全可靠的在线干燥时间和/或能量消耗最小化。这些算法将利用第一性原理、模型和模拟、实验数据和中试工厂的在线测试来开发。在该项目中开发的柔性制造工具和知识将帮助辉瑞蒙特利尔公司将自己定位为整个辉瑞制造网络的新型创新制造技术的全球研发中心。

Even if remarkable progress has been recently achieved, the manufacturing efficiency of the pharmaceutical industry still lags behind that of most other industries. Automation and continuous processing is a way to become more competitive, to reduce production time, energy consumption and the amount of waste produced. Indeed, better sensors and closed-loop feedback control system enable the transition toward a more desirable quality by design-based, rather than quality by testing-based, manufacturing of the next generation of pharmaceutical products. They also reduce process variability and operator errors and lead to a better understanding of the process.The objective is to increase the automation of three processes that present mass and heat exchanges:- Coating of the tablets: development of a in-line vision sensor providing film-coating properties (coating level, distribution across tablets esthetical defects, etc.).- Drying of the granules (before they are compressed into tablets): safe and robust in-line minimization of the drying time and/or energy consumption.- Freeze-drying of vials: safe and robust in-line minimization of the drying time and/or energy consumption.The algorithms will be developped using first principles modelling and simulations, experimental data and in-line tests on pilot plants. The tools and knowledge of flexible manufacturing developed during this project will help Pfizer Montreal to position itself as a global research and development centre for new and innovative manufacturing technologies for the entire Pfizer manufacturing network.