FluidBedDryer(流化床干燥工艺检测)例析.ppt

NIR Experience in the Pharmaceutical IndustryIn-Line, On-Line, At-Line By Brimrose NIR Team Overview of Pharmaceutical Manufacture制药概述 Packaged Product包装成品 Drug Product药物产品 Blending Granulation混合颗粒化 Excipient辅药 Drug Substance原料药 M NIR on a Glatt Fluid Bed Dryer By John Richmond Agenda日程 Installation安装 Calibration Results校准结果 On-line Results for each batch每批在线结果 Glatt FBD Diffuse Reflectance Probe inserted at same level and penetration as temperature probes漫反射探头安装在温度探头相同的水平和渗透度范围上 Real time results during 2nd drying cycle第二次干燥循环的实时结果 Operators see moisture value on Glatt control panel (4-20mA output)可在Glatt控制面板上看到湿度值 Installation Analyser in waterproof/dust-tight enclosure分析仪在防水防尘机箱内 Fiber-optic cable in conduit光纤在导管内 No need to disconnect fibers when opening the door开门时，无需断掉光纤 Real time Spectra Spectra pre-processed Spectra Calibration 57 samples used in Calibration Set校准集用了57个样品 Range from 1.58% - 4.97%范围 Temperature included in calibration -- range from 35C to 45C校准包含的温度范围 Algorithm算法 is PLS2 -- provides linkage between moisture and temperature在温湿度间建立联系 -- compensates for temperature differences补偿温差 Calibration Set Validation -- Accuracy fits well with Computrac Regression Coefficients Moisture Bands Typical Results -- DM988 Equivalence Multiple Products in FBDPC1, 2 and 3 Conclusions结论 Even though the calibration has very few samples, real time prediction is as accurate as Computrac即使校准只有几个样品，实时预测仍然像Computrac一样准确。 Real time results means operators can dry to the optimum level -- no re-drys实施结果意味着操作者可干燥至合适的水平-无需再次干燥 Batch cycle times can be significantly reduced可大大减少每批次循环时间 Will also tell if the FBD is charged correctly