Pharmaceutical manufacturing: automation of heat and mass transfer processes

即使最近取得了显著进展，制药业的制造效率仍然落后于大多数其他行业。自动化和连续加工是一种提高竞争力、减少生产时间、能源消耗和废物产生量的方法。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的质量过渡到更理想的质量，而不是基于测试的质量，制造下一代药品。它们还减少了工艺的可变性和操作员的错误，从而更好地理解工艺。其目的是提高三个过程的自动化，这些过程存在质量和热交换：-片剂包衣：开发在线视觉传感器，提供薄膜包衣性能（包衣水平，片剂之间的分布，美学缺陷等）。颗粒干燥（在压缩成片剂之前）：安全可靠的在线干燥时间和/或能耗最小化。小瓶冷冻干燥：安全可靠的在线最小化干燥时间和/或能耗。算法将使用第一原理建模和模拟、实验数据和中试工厂的在线测试来开发。 在此项目中开发的柔性制造工具和知识将帮助辉瑞蒙特利尔将自己定位为整个辉瑞制造网络的新的和创新的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.