Fluid Bed Dryer(流化床干燥工艺检测)

1、NIR Experience in the Pharmaceutical IndustryIn-Line, On-Line, At-LineByBrimrose NIR TeamOverview of Pharmaceutical Manufacture制药概述PackagedProduct包装成品包装成品Drug Product药物产品药物产品BlendingGranulation混合颗粒化混合颗粒化Excipient辅药辅药Drug Substance原料药原料药MNIR on a Glatt Fluid Bed DryerByJohn RichmondAgenda日程zInstallat

2、ion安装zCalibration Results校准结果zOn-line Results for each batch每批在线结果Glatt FBDz 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z Real time results during 2nd drying cycle第二次干燥循环的实时结果z Operators see moisture value on Glatt control panel (4-2

3、0mA output)可在Glatt控制面板上看到湿度值Installationz Analyser in waterproof/dust-tight enclosure分析仪在防水防尘分析仪在防水防尘机箱内机箱内z Fiber-optic cable in conduit光纤在导管内光纤在导管内z No need to disconnect fibers when opening the door开门时，无需断掉光纤开门时，无需断掉光纤Real time SpectraSpectra pre-processedSpectraCalibrationz57 samples used in Cal

4、ibration Set校准集用了57个样品zRange from 1.58% - 4.97%范围zTemperature included in calibration - range from 35C to 45C校准包含的温度范围zAlgorithm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 SetValidation - Accuracy fits well with Com

5、putracRegression CoefficientsMoisture BandsTypical Results - DM988SamplePredicted DeviationReference1/12-16:27;043.0960.2473.1418:11:073.4980.2423.818:25:093.1620.2453.462/12-13:37:054.4880.2044.61EquivalenceNIRComputrac3.0963.143.4983.83.1623.464.4884.612.5812.52.9222.932.1582.08SEP0.127751Corr0.98

6、7449Equivalence - NIR and Computrac22.533.544.5522.533.544.55NIRComputracMultiple Products in FBDPC1, 2 and 3Conclusions结论zEven 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。zReal 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zBatch c