Tag Archives: pharma qbd

AIChE 2010中的PAT–实时监测制粒过程和滚动致密过程

在盐湖城举行的2010 美国化工学会 (AIChE) 年会中,一些出席良好的分会与质量源于设计(QbD) 和工艺过程分析技术(PAT)相关。

美国化工学会年会最近,我在PharmaQbD 博客上以嘉宾身份发表了一个对QbD 和PAT 的简要回顾,题为“如果QbD 是地图,PAT即是GPS”。本博客贴文的出发点是QbD 和PAT以互补的方式来应用是最有效的。在AIChE年会中,可以看到许多好的例子,它们基于将通过QbD实验开发出来的工艺模型应用到后期开发和生产上,在PAT的指导下进行实时监测和控制。

许多讨论关注到药品制造的连续工艺过程,反映了制药生产技术的明显提高。然而,这种提高也同时证实了对(通过QbD)理解工艺过程的需求,以便与工艺过程监测(PAT的一关键要素)相匹配。例如,好几个报告介绍了在滚动致密过程中连续监测颗粒大小的分布,从而提供测量和控制关键质量属性的潜在能力。颗粒(细粒)大小直接影响到粉末的流动性和可压性,通过导致最终制剂的溶出/解体特征的不同进而影响到原料药的生物活性。

如果您对应用工艺过程测量技术来实时理解颗粒和制粒系统感兴趣,我向您建议以下两个免费历届网络研讨会:

PAT at AIChE 2010 – Real-time Monitoring of Granulation and Roller Compaction

At the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting in Salt Lake City, there were a number of well-attended sessions dealing with the related topics of Quality by Design (QbD) and Process Analytical Technologies (PAT). Continue reading

Green Pharmaceutical Manufacturing on a Foundation of PAT & QbD

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com.

Next week, METTLER TOLEDO is hosting a webcast on using Process Analytical Technology (PAT) and Quality by Design (QbD) for the greening of drug manufacturing operations. I’ll be kicking off the program by discussing the potential of the industry to leverage PAT/QbD to meet corporate sustainability objectives such as reducing energy usage and cutting carbon emissions. It’ll be a big-picture look at the elements of PAT and QbD that overlap with sustainable manufacturing. Continue reading