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1. 发明授权

US09879909B2 Method for monitoring the secondary drying in a freeze-drying process 有权
公开(公告)号：US09879909B2
公开(公告)日：2018-01-30
申请号：US12502863
申请日：2009-07-14
申请人： Davide Fissore , Antonello Barresi , Roberto Pisano
发明人： Davide Fissore , Antonello Barresi , Roberto Pisano
IPC分类号： F26B5/06
CPC分类号： F26B5/06
摘要： A method to monitor a secondary drying phase of a freeze-drying process comprises initial steps in which is provided to perform pressure rise tests at different time and to calculate a respective value of experimental desorption rate of product (steps 1 to 3). Subsequently, the method provides to estimate initial conditions and kinetic constants of a kinetic model of the process (step 4) and to calculate at time t=t2 a respective residual moisture content and a respective desorption rate (step 5). The method can be performed in a freeze-dryer apparatus which includes a drying chamber that contains a product to be dried and can be isolated to perform pressure rise tests.

2. 发明授权

US08117005B2 Optimization and control of the freeze-drying process of pharmaceutical products 有权
标题翻译：药品冷冻干燥过程的优化与控制
公开(公告)号：US08117005B2
公开(公告)日：2012-02-14
申请号：US12296802
申请日：2007-04-10
申请人： Antonello Barresi , Giancarlo Baldi , Marco Parvis , Alberto Vallan , Salvatore Velardi , Hassan Hammouri
发明人： Antonello Barresi , Giancarlo Baldi , Marco Parvis , Alberto Vallan , Salvatore Velardi , Hassan Hammouri
IPC分类号： G01K17/00 , G01K3/00
CPC分类号： G01K1/024 , F26B5/06 , G01N33/15
摘要： A system for monitoring the lyophilization process of a product in containers (4, 4a, 4b) arranged inside a lyophilization chamber, including a temperature measurement system (6) associated with each container housed inside (10) the lyophilization chamber, capable of surveying local temperature data for each container. The system includes a wireless communication system (8) for the surveyed temperature data and a processing module (16) for said data, located externally to the lyophilization chamber, programmed to determine at least one parameter indicative of the progress of the lyophilization process not measured by the measurement system, through the use of a predetermined representation model of the process, capable of correlating a local temperature value of the container with the parameter.
摘要翻译：一种用于监测设置在冻干室内的容器（4,4a，4b）中的产品的冷冻干燥过程的系统，包括与容纳在所述冻干室内的每个容器（10）相关联的温度测量系统（6），所述容器能够测量局部每个容器的温度数据。该系统包括用于测量温度数据的无线通信系统（8）和位于冻干室外部的用于所述数据的处理模块（16），被编程为确定指示未测量的冻干过程进展的至少一个参数通过测量系统，通过使用能够使容器的局部温度值与参数相关联的该过程的预定表示模型。

3. 发明申请

US20100018073A1 METHOD FOR MONITORING THE SECONDARY DRYING IN A FREEZE-DRYING PROCESS 有权
标题翻译：用于在冷冻干燥过程中监测二次干燥的方法
公开(公告)号：US20100018073A1
公开(公告)日：2010-01-28
申请号：US12502863
申请日：2009-07-14
申请人： Davide Fissore , Antonello Barresi , Roberto Pisano
发明人： Davide Fissore , Antonello Barresi , Roberto Pisano
IPC分类号： F26B5/06
CPC分类号： F26B5/06
摘要： A method to monitor a secondary drying phase of a freeze-drying process comprises initial steps in which is provided to perform pressure rise tests at different time and to calculate a respective value of experimental desorption rate of product (steps 1 to 3). Subsequently, the method provides to estimate initial conditions and kinetic constants of a kinetic model of the process (step 4) and to calculate at time t=t2 a respective residual moisture content and a respective desorption rate (step 5). The method can be performed in a freeze-dryer apparatus which includes a drying chamber that contains a product to be dried and can be isolated to perform pressure rise tests.
摘要翻译：监测冷冻干燥过程的二次干燥阶段的方法包括初始步骤，其中提供用于在不同时间进行压力升高测试并计算产物的实验解吸速率的相应值（步骤1至3）。随后，该方法提供估计过程的动力学模型的初始条件和动力学常数（步骤4），并在时间t = t2计算相应的残余水分含量和相应的解吸速率（步骤5）。该方法可以在包括干燥室的冷冻干燥装置中进行，所述干燥室含有要干燥的产品并且可以被隔离以进行升压试验。

4. 发明授权

US08800162B2 Method and system for controlling a freeze drying process 有权
标题翻译：控制冷冻干燥过程的方法和系统
公开(公告)号：US08800162B2
公开(公告)日：2014-08-12
申请号：US12441752
申请日：2007-09-19
申请人： Salvatore Velardi , Antonello Barresi
发明人： Salvatore Velardi , Antonello Barresi
IPC分类号： F26B5/06
CPC分类号： F26B5/06
摘要： A method for monitoring and/or controlling and a freeze drying process in a freeze dryer apparatus provided with a drying chamber having a temperature-controlled shelf supporting containers of a product to be dried, comprises during a primary drying phase of the freeze drying process the steps of: isolating the drying chamber closing an isolating valve thereof and sensing and collecting pressure values inside the drying chamber for a defined pressure collecting time and a shelf temperature of the temperature-controlled shelf (Step 1); calculating a product temperature of product and a plurality of process/product related parameters (Step 2); calculating a new shelf temperature and a sequence of shelf temperatures up to the end of the primary drying phase, that maximizes a sublimation rate of the product maintaining the product temperature below a maximum allowable product temperature.
摘要翻译：一种用于在冷冻干燥设备中设置有具有受温度控制的搁板支撑待干燥产品的容器的干燥室的冷冻干燥设备的方法包括在冷冻干燥过程的初级干燥阶段期间，步骤：隔离干燥室，关闭其隔离阀，并感测并收集干燥室内的压力值，确定温度控制搁架的压力收集时间和搁板温度（步骤1）; 计算产品的产品温度和多个工艺/产品相关参数（步骤2）; 计算新的搁板温度和直到初级干燥阶段结束的搁板温度序列，使产品的升华速率最大化，使产品温度保持在最大允许产品温度以下。

5. 发明申请

US20100107436A1 METHOD AND SYSTEM FOR CONTROLLING A FREEZE DRYING PROCESS 有权
标题翻译：冷冻干燥过程控制方法及系统
公开(公告)号：US20100107436A1
公开(公告)日：2010-05-06
申请号：US12441752
申请日：2007-09-19
申请人： Salvatore Velardi , Antonello Barresi
发明人： Salvatore Velardi , Antonello Barresi
IPC分类号： F26B5/06 , G05B15/00
CPC分类号： F26B5/06
摘要： A method for monitoring and/or controlling a freeze drying process is characterized by the use of an estimator algorithm. A product to be dried is arranged in at least one container on a temperature-controlled shelf in the drying chamber of a freeze dryer apparatus. During a primary drying phase, the drying chamber is isolated by closing an isolating valve. Pressure values inside the drying chamber are measured and collected for a defined pressure collecting time and a temperature of the temperature-controlled shelf. A product temperature for the product is calculated together with a plurality of process/product related parameters. A new shelf temperature is calculated with a sequence of shelf temperatures up to the end of the primary drying phase that maximizes a sublimation rate of the product in order to maintain the product temperature below a maximum allowable product temperature.
摘要翻译：用于监测和/或控制冷冻干燥过程的方法的特征在于使用估计器算法。待干燥的产品布置在冷冻干燥设备的干燥室中的温度受控架上的至少一个容器中。在初级干燥阶段期间，通过关闭隔离阀来隔离干燥室。测量和收集干燥室内的压力值以确定压力收集时间和温度控制搁架的温度。产品的产品温度与多个工艺/产品相关参数一起计算。通过一系列搁架温度计算新的搁架温度，直到初级干燥阶段结束，使产品的升华速率最大化，以便将产品温度保持在最大允许产品温度以下。

6. 发明申请

US20090276179A1 OPTIMIZATION AND CONTROL OF THE FREEZE-DRYING PROCESS OF PHARMACEUTICAL PRODUCTS 有权
标题翻译：药用产品冷冻干燥过程的优化与控制
公开(公告)号：US20090276179A1
公开(公告)日：2009-11-05
申请号：US12296802
申请日：2007-04-10
申请人： Antonello Barresi , Giancarlo Baldi , Marco Parvis , Alberto Vallan , Salvatore Velardi , Hassan Hammouri
发明人： Antonello Barresi , Giancarlo Baldi , Marco Parvis , Alberto Vallan , Salvatore Velardi , Hassan Hammouri
IPC分类号： G06F15/00 , G01K13/00
CPC分类号： G01K1/024 , F26B5/06 , G01N33/15
摘要： A system is described for monitoring the lyophilisation process of a product in containers (4, 4a, 4b) arranged inside a lyophilisation chamber, comprising a temperature measurement system (6) associated with each container housed inside (10) said lyophilisation chamber, capable of surveying local temperature data for each container. The system includes: a wireless communication system (8) for the surveyed temperature data; and a processing module (16) for said data, located externally to the lyophilisation chamber, programmed to determine at least one parameter indicative of the progress of the lyophilisation process not measured by the measurement system, by means of a predetermined representation model of the process, capable of correlating a local temperature value of the container with said parameter.
摘要翻译：描述了一种用于监测设置在冻干室内的容器（4,4a，4b）中的产品的冻干过程的系统，其包括与容纳在所述冻干室内的每个容器（10）相关联的温度测量系统（6），所述温度测量系统能够测量每个容器的当地温度数据。该系统包括：用于测量温度数据的无线通信系统（8）以及位于所述冻干室外部的用于所述数据的处理模块（16），其被编程为通过所述过程的预定表示模型来确定指示所述冻干过程未被所述测量系统测量的进展的至少一个参数能够将容器的局部温度值与所述参数相关联。

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