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公开(公告)号：US5603894A
公开(公告)日：1997-02-18
申请号：US332191
申请日：1994-10-31
申请人： Albert J. Aikus , Joaquin Mayoral
发明人： Albert J. Aikus , Joaquin Mayoral
CPC分类号： A61L2/0023 , A61L2/04
摘要： The present invention provides a method and apparatus for sterilizing a pharmaceutical composition, the method comprising providing a sterilization system including a heat exchanger for elevating and then lowering the temperature of the fluid in a time period; measuring temperature at an input of the heat exchanger, measuring temperature at an output of the heat exchanger and measuring temperature at least one point in the heat exchanger intermediate to the input and output; calculating a coefficient of heat transfer for the sterilization system using the temperature measurements; calculating a degree of sterilization (F.sub.o) using the coefficient; and adjusting the temperature of the heat exchanger to minimize degradation of the pharmaceutical composition while maintaining an acceptable degree of sterilization.
摘要翻译： 本发明提供一种灭菌药物组合物的方法和装置，该方法包括提供一种灭菌系统，该灭菌系统包括一段时间内升高并降低流体温度的热交换器; 测量热交换器输入端的温度，测量热交换器输出端的温度，并将热交换器中至少一点的温度测量到输入和输出; 使用温度测量计算灭菌系统的传热系数; 使用系数计算灭菌程度（Fo）; 并且调节热交换器的温度以使药物组合物的降解最小化，同时保持可接受的灭菌程度。
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公开(公告)号：US5498396A
公开(公告)日：1996-03-12
申请号：US332006
申请日：1994-10-31
申请人： Albert J. Aikus , James T. Renick
发明人： Albert J. Aikus , James T. Renick
CPC分类号： A61L2/04 , A61L2/0023
摘要： A sterilization system for sterilizing a solution such as a parenteral solution or diluent generally includes an arrangement for supplying a solution to be sterilized from an associated source, at least one first heat-exchanger for elevating the temperature of the solution, and at least one second heat-exchanger for subsequently cooling the solution. The system further includes an arrangement for pressurizing the system with sterile gas which is used to effect "dry-start up" of the system and to shut-down the system to minimize product losses.
摘要翻译： 用于灭菌诸如肠胃外溶液或稀释剂的溶液的消毒系统通常包括用于从相关源供应待灭菌溶液的装置，至少一个用于提高溶液温度的第一热交换器，以及至少一个第二 热交换器，用于随后冷却溶液。 该系统还包括用无菌气体对系统加压的装置，其用于实现系统的“干启动”并关闭系统以最小化产品损失。
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