Merck(Online-Blending)默克(在线混料).ppt

Active vs. blank formulation: lubrication Lubrication of active vs. blank formulation Pilot scale 活性 vs. 无效配方: 润滑 活性 vs. 无效配方的润滑 试验尺寸 Process scale-up Pilot vs. full-scale Same formulation 过程混料机尺寸增大 试验 vs. 全尺寸 相同配方 Process scale-up - lubrication Pilot vs. full scale Lubrication of blank formulation 过程混料机尺寸增大- 润滑 试验vs. 全尺寸 无效配方润滑 Blend dynamics – large fill volume Lubrication of granule formulation ~ 95% fill volume Lubricant added through bottom of blender 混料动力– 大的填料体积 颗粒配方的润滑 ~ 95% 填料体积 通过混料机底端添加润滑剂 Summary Conclusions A rapid, non-invasive, information-rich approach to blend uniformity has been applied toward process development, scale-up, monitoring Two data analysis approaches considered: Moving block Calibration-free Each point corresponds to multiple revolutions Wavelength correlation Requires pre-defined library Each point corresponds to one revolution Endpoint criteria -- based on sampling considerations and data analysis approach Near-IR and traditional characterization (sample thief) are complementary tools Different information Value during development 总结与结论 在处理开发，体积增加和监控过程中应用了一个快速无损和信息丰富的方法测定混料均匀性 使用了两种数据分析方法: 移动块 免校准 每个点对应多转数 波长相关性 需要预定义库 每个点对应一转 终点标准– 基于采样注意事项和数据分析方法 近红外和传统特征(取样) 为补充条件 不同信息 开发过程中的数值 On-going Future Work… Evaluate other vendors/technologies S/N, wavelength range, interrogation volume Adaptation to other blenders Smaller scales Types of blenders Data analysis approach 现在及未来的工作… 评估其他供应商/技术 S/N, 波长范围, 需测定的容积 适用其他混料机 更小的体积 混料机类型 数据分析方法 Acknowledgements 鸣谢 RD Analytical Rebecca Evans, Chris John, Katie Kleissas, Ryan Todd, Betsy Powlus, Dominic Ip RD Engineers / formulators Brad Holstine, Edward Smith, Maria Rozinsky, Larry Rosen, Tom Guellich, Prad Godbole MMD-Process Analytics Rob Guenard, Ramasamy Manoharan, Jennifer-Finnegan McCafferty MMD Alan Silverman, Hazem Eleskandarani, Jean Hacherl, Colleen Michaels, Kaishik Jayakar, Jennifer Blatteau, Riccardo Rossi, Poplin Strickland Pharmaceutical Process Analytics On-li