TDLAS-based SMART Freeze Dryer Process Development Technology

描述（由申请人提供）：物理科学公司与康涅狄格大学和SP科学公司合作，将开发一种结合硬件/软件的产品，使制药科学家能够在实验室和生产规模的冻干机上快速开发强大的产品冷冻干燥循环。该产品的开发将通过可调谐二极管激光吸收光谱（TDLAS）水蒸气质量流量传感器和基于小瓶冷冻干燥的传热传质模型的过程控制算法之间的软件通信来完成。传感器支持的水蒸气质量流量测定与该模型相结合，可以在干燥过程中非侵入式地测定产品温度，这是一个关键的工艺参数。产品温度的测定将为实验室、中试和生产规模冷冻干燥的开发和控制提供过程控制参数。所建议的工艺开发软件将为制药客户节省数月的时间来开发他们的工艺设计空间和最佳周期。过程控制软件将实现实时监测和控制，也可以缩短初级干燥过程时间。这一点很重要，因为初级干燥是冻干过程中最长的部分，可以持续数天。在软件开发之后，将在康涅狄格大学和SP科学公司进行广泛的实验室实验，以评估测量精度和自动化过程周期控制，以开发优化的干燥操作。冻干过程放大和过程控制的标准操作程序将根据产品的使用情况制定。

DESCRIPTION (provided by applicant): Physical Sciences Inc. in collaboration with the University of Connecticut and SP Scientific will develop a combined hardware/software product that will enable pharmaceutical scientists to rapidly develop robust product freeze drying cycles on both laboratory and production scale lyophilizers. The product development will be accomplished through the combination of software enabling communication between a Tunable Diode Laser Absorption Spectroscopy (TDLAS) water vapor mass flow rate sensor and a process control algorithm based upon a heat and mass transfer model of vial freeze drying. Sensor enabled water vapor mass flow rate determinations combined with the model will enable non-intrusive determination of product temperature during drying, a key process parameter. Product temperature determinations will provide a process control parameter for developing and controlling freeze drying during laboratory, pilot and production scale freeze drying. The proposed process development software will save pharmaceutical customers months of time in developing their process design space and an optimum cycle. The process control software will enable real-time monitoring and control that could also shorten the primary drying process time. This is significant since primary drying is the longest part of the lyophilization process and can last for days. Following the software development extensive laboratory experimentation will be carried out at the University of Connecticut and SP Scientific to assess measurement accuracy and automated process cycle control for the development of optimized drying operations. A standard operating procedure for lyophilization process scale-up and process control will be developed based on the use of the product.