TDLAS-based SMART Freeze Dryer Process Development Technology

基于TDLAS的SMART冻干机工艺开发技术

• 批准号: 8979381
• 负责人: WILLIAM J KESSLER
• 金额: $ 48.84万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8979381
• 关键词: Address; Algorithms; Application procedure; Biologic Development; Collaborations; Communication; Computer software; Connecticut; Cost Control; Data; Development; Drug Costs; Drug Formulations; Drug Industry; Education; Educational process of instructing; Elements; Equipment; Freeze Drying; Freezing; Goals; Health; Heating; Industry; Institution; Laboratories; Laboratory Study; Lasers; Measurement; Modeling; Monitor; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Procedures; Process; Production; Reporting; Research; Scientist; Shipping; Ships; Societies; Spectrum Analysis; Technology; Temperature; Testing; Time; United States Food and Drug Administration; Universities; Vial device; absorption; base; commercialization; cost; design; drug production; improved; meetings; operation; physical science; pressure; process optimization; product development; programs; reconstitution; research and development; research study; scale up; sensor; software development; success; technology development; time use; water vapor

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.

描述（由申请人提供）：Physical Sciences Inc.与康涅狄格大学和SP Scientific合作，将开发一种组合硬件/软件产品，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冻干周期。产品开发将通过结合软件实现可调谐二极管激光吸收光谱（TDLAS）水蒸气质量流速传感器与基于小瓶冷冻干燥传热传质模型的过程控制算法之间的通信来完成。传感器使能的水蒸汽质量流率测定与模型相结合，将使非侵入性的确定产品温度在干燥过程中，一个关键的过程参数。 产品温度测定将为实验室、中试和生产规模冷冻干燥期间开发和控制冷冻干燥提供工艺控制参数。拟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，还可以缩短初级干燥过程时间。 这是重要的，因为初级干燥是冻干过程中最长的部分，并且可以持续数天。软件开发完成后，将在康涅狄格大学和SP Scientific进行广泛的实验室实验，以评估测量精度和自动化工艺周期控制，从而开发优化的干燥操作。将根据产品的使用情况，制定冻干工艺规模扩大和工艺控制的标准操作规程。