冷冻干燥机的验证：.pdfVIP

冷冻干燥机的验证： 冷冻干燥室通过在低温状态通过真空从产品中将水份升华的一个复杂过程。这 样的设备通常被称作冷冻干燥机，它的热分布是一个非常复杂的类型。一个冷 冻干燥机拥有很多层空间位置距离很近的隔板来承载需要冻干的制品。准确的 测量工艺周期中隔板的温度是非常具有挑战性的，特别是如果使用热电偶来测 量。 Lyophilization is a complex process of removing water from the product through sublimation at low temperature vacuum. The equipment (often called freeze dryers) is a very difficult type of chamber to thermally map. A freeze dryer has many shelves that are closely spaced together to hold product. Accurately measuring the shelf temperature during the process cycle can be quite challenging particularly if using thermocouples. 将热电偶安装进冻干机内室非常耗费时间的一件事情。热电偶必须通过特殊的 法兰装置通过真空管道进入腔体。每只热电偶的顶端都必须仔细地“绑”或者 贴合在每一层隔板的多个位置上。如果做得不妥当，隔板均匀性的温度的测量 将不会准确。真空的泄露和热电偶的破损是常见的麻烦会大大增加设备停机的 时间。 Installation of thermocouples into a freeze dryer is very time intensive. Thermocouples must be threaded into the chamber through the vacuum line using a special flange assembly (see Accessories). The tip of each thermocouple must be carefully “strapped’ or taped onto multiple positions of each shelf. If not done properly, the shelf temperature measurements will not be accurately mapped. Vacuum leaks and broken thermocouples are common problems which can add significantly to equipment downtime. 使用基于热电偶的测量系统（例如 XpertVal 系统）来进行隔板均匀性验证这项 应用，如果仅仅从希望看到实时数据这个角度来说才是必须的。比方说，冻干 机是新的从来没有被验证过。从这个角度而言，看实时数据可能有利于机械工 作的调整或者是确定装载的配置。 Using a thermocouple based system (i.e. XpertVal System) for this application should be considered only if seeing “live data” is absolutely necessary. For example, the freeze dryer is new and has never been qualified. In this case, seeing “live data” may be advantageous to allow for mechanical adjustments or to determine product load configurations. 更好的替代方法是使用被设计来处理这个应用的无线数据记录器。LIVES XpertLog 无线数据记录器系统是理想地适合用来对冻干机进行测量。每个数 据记录器都有一个 18 英寸的 RTD 传感器延长线。一个铜制底座可以载上每只 数据记录器的底部。底座