FDA鼓励在药物生产和质量控制中使用现代工艺分析技术（PATS）。这促使该行业从经验上转变为基于科学的制造业标准。亚博老虎机网登录结果，新技术正在进入制药行业的制造业。
Process Analytical Technologies enable the analysis and control of manufacturing processes to assure acceptable quality at the completion of the process. This is based on measuring critical quality parameters and performance attributes of raw and in-process materials and processes.
监测干粉的水分/溶剂含量对于确保实现正确的粉末特性至关重要。液体床液间在混合和片剂之前通常用于药物制造中的干粉产品。标准操作方法涉及对样品进行初级分析，例如karl-fischer滴定或干燥时损失，或在特定时间段内干燥产品。这两种方法都不能确保对干燥过程的持续控制，因此不能保证反复为产品提供指定水分所需的紧密控制。近红外光谱与在线扩散反射率测量或通过观察端口进行非接触式测量的结合是一种有效的替代方案，可提供连续监测干燥过程的手段。
近红外分析流体床干燥机中的粉末水分
流体床干燥的碗通常具有方便的窗口，可以通过该窗口进行非接触，近红外的漫射反射测量。这布鲁克光学矩阵fduplex near infrared spectrometer and emission head is an ideal way of measuring through a window. The emission head has four sources, which can be controlled individually based on the sample reflectivity. A single 600-mm fiber links each emission head to the spectrometer.
应用
A MATRIX-F duplex system was utilized to monitor the moisture content of a powder in a fluid bed drier using a viewing port in the fluid bed drier bowl. An essential consideration for the non-contact measurement is that the powdered material is constantly exchanged on the viewing window so that the NIR spectra are representative of the changing moisture content in the bulk powder. Near infrared spectra as shown in Figure 1 were continuously measured (16 scans, of roughly 8 s, at 8 cm-1resolution) during the drying process in addition to time stamped samples for primary analysis.
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Figure 1.在整个干燥步骤中收集的样品的FT-NIR吸收光谱。明确观察到与干燥过程和水分变化相关的显着差异。
将拉的样品与同时测量的近红外光谱相关，并开发了校准模型（图2）。
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图2。Cross validation results of a PLS based model for prediction of the water content, which show a very high correlation coefficient (98.61) and a low error (0.4%).
A profile of the drying process is shown in Figure 3. Near-infrared spectra results from a combination and overtone bands of C-H, N-H, O-H, etc. vibrations. Since most reaction mixtures and solvents contain some organic components with these bonds, they are suitable for near-infrared analysis.
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图3。这fluid bed drier moisture profile as measured by non-contact near infrared analysis.
Opus/定量定量分析软件包使用部分租赁方（PLS）来开发定量模型。通常，模型的开发需要测量包含一系列感兴趣组成部分的样品。然后，应用唯一的量子自我选式例程来开发校准模型。图1包括在干燥过程中在各个阶段收集的样品的一些光谱。这些光谱与同时从干燥机中捕获的样品相关，并使用标准方法进行分析，例如损失干燥或karl-fischer滴定。
测量选项
Bruker Optics提供了各种各样的仪器，可满足所有特定需求。对于过程应用程序，MATRIX-F FT-NIR spectrometeris recommended due to its multiplexing capability, ruggedness and easy serviceability. A wide variety of process measurement accessories are offered for in-line and on-line measurements of liquids, solids and slurries. Near-infrared sample spectra can be collected from driers using either a contact measurement (diffuse reflectance probes which require a port) or a non-contact mode (diffuse reflectance through a window). Both methods utilize a diffuse reflectance measurement and depend on the product exchange on the probe tip/window in order to sample the changing product. The non-contact measurement has the advantages that no modifications are needed to the equipment and a larger sample area can be measured.
执行
光纤的使用有助于将仪器定位在测量站点旁边或控制室中的危险位置的围栏中。通常可以在不到一分钟的时间内收集高质量的光谱，并且对多个组件的定量分析很容易进行。在过程环境中，矩阵F双链体可以与过程软件ADIO一起使用，以执行样品的测量和分析，并通过多种I/O选项（例如4-20 MA，Modbus，profibus）输出结果，工业以太网等
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This information has been sourced, reviewed and adapted from materials provided by Bruker Optics.
有关此消息来源的更多信息，请访问Bruker Optics。