Tag Archives: PAT

Process Analytical Technology

不修改或取代反应器即可实施工艺过程分析技术

在开发工艺过程分析技术(PAT)的使用上所作的承诺和投入是制药工业能够找到系统化和改进生产工艺过程的主要原因。然而,在实施工艺过程分析技术(PAT)时存在各种明显的挑战,比如像测量仪器与分级危害性区域以及现有工艺加工基础设施的匹配性。更重要的是,怎样做到原位化学采样分析。现今在运行使用的大部分反应器容器都缺乏适合这类测量技术所需的进入点,为此要作修改或取代,这会显著增加项目成本或彻底阻止实施。 Continue reading

工艺过程开发会议, Weggis, 瑞士

工艺过程开发会议

我高兴地宣布 第十八届国际工艺过程开发会议 (IPDC) 将于2011年9月25-29日在瑞士Weggis举行。今年的会议将注重于制药、精细与特种化学品工业里的从化合物开发到生产工作流程:

  • 化学研究与开发
  • 工艺过程特征分析和结晶
  • 工艺过程安全与放大
  • 生产

第十八届国际工艺过程开发会议 的特殊聚焦领域是:

  • 工艺过程分析技术/质量源与设计 (PAT/QbD)
  • 连续工艺过程与流动化学
  • 动力学

我感到兴奋因为这次会议将汇聚来自不同跨国和当地的化学与制药公司的各种技术报告和参会人员。这些报告会反映常见的、以及某公司特定的解决问题的途径,并给参会者们提供一个讨论的平台。幸运的是大部分知名跨国制药、精细与特种化学品公司都出席我们的国际工艺过程开发会议。

如果您没能参加我们的第十七届国际工艺过程开发会议,您可以在此阅读部分的会议报告。

AIChE Call For Crystallization Papers

The 2011 American Institute of Chemical Engineers (AIChE) Annual Meeting – to be held October 16-21 in Minneapolis, MN – features a number of sessions on crystallization and evaporation.  Continue reading

Enable Process Analytical Technology Without Modifying or Replacing Reactors

Commitment and investment to develop the use of Process Analytical Technology (PAT) is a primary reason why the pharmaceutical industry is able to find ways to streamline and improve manufacturing processes. However, there are significant challenges when implementing Process Analytical Technology (PAT) into larger-scale manufacturing, such as compatibility of measurement instrumentation with classified hazardous areas and the existing processing infrastructure. Even more important is how to sample the chemistry in situ. The majority of reactor vessels in commission today lack suitable entry points for the measurement technology that requires there modification or replacement, which can significantly increase project costs or prohibit implementation entirely. Continue reading

IFPAC 2011上谈PAT与颗粒大小分析

2010工艺过程中的颗粒论坛会上的三位报告者将在2011年1月21日于(美国)马里兰州的巴尔的摩举行的IFPAC (工艺过程分析技术国际论坛)上作报告。Johnson & Johnson的Steve Mehrman和Merck & Co. 的James Butz被排在周五上午的“颗粒特征分析超声光谱”IFPAC 的第五分会作报告。Bristol-Myers Squibb的Kevin Macias将在周五上午的“药品开发与生产的控制战略”第七分会中作报告。 Continue reading

Process Development Conference, Weggis, Switzerland

I am happy to announce that the 18th International Process Development Conference (IPDC) will be held September 25 to September 29, 2011 in Weggis, Switzerland.  This year’s conference will focus on workflows from compound development to manufacturing in the pharmaceutical, fine and specialty chemical industries: Continue reading

PAT & Particle Size Analysis at IFPAC 2011

Three speakers from the 2010 In-Process Particle Forum will present at IFPAC [International Forum Process Analytical Technology] on January 21, 2011 in Baltimore, MD.  Steve Mehrman  of Johnson & Johnson and James Butz of Merck & Co. are scheduled to present during the Particle Characterization/Analysis-Ultrasound Spectroscopy Friday AM V session at IFPAC.  Kevin Macias of Bristol-Myers Squibb will present during the Control Strategies for Drug Product Development and Manufacturing Friday AM VII session. Continue reading

Why Measure Particle or Droplet Distribution in Process or Development?

After last week’s introduction to liquid dosage formulations, I wanted to follow-up with: why measure the particle or droplet distribution in process or in development? Continue reading

工艺过程分析技术在 EuroPACT 2011

在我瞻望 2011年时, 一个重要的事件是 EuroPACT 2011:第二届工艺过程分析和控制技术欧洲会议。EuroPACT 2011将于四月26至29日在Glasgow召开。成立于2006年, EuroPACT会议覆盖工艺过程分析和工艺过程表现的监测,以及将这些技术实施到各种技术领域里(包括数据向知识的转换)和工业部门。

我要点出该会上的一个张贴报告 – 用工艺过程分析技术更快地优化和解决问题:实时测量晶体布局。

如以前讨论过的,结晶是一个复杂的工艺过程,其最终晶体产品取决于热力学以及动力学和物理现象。处理结晶过程的复杂性有两种传统方法 – 或是让固体从溶液中突然析出然后在工艺下游解决问题,或是减小结晶釜以避免常见问题。这两种方法都没有为保证产品质量和提高生产率及输出而进行优化。这使得人们对用工艺过程分析技术(PAT)实时监测结晶过程产生了兴趣,它能直接测量关键工艺参数,像晶体大小和形状的分布、晶型、乃至溶液的过饱和度。

实时监测结晶过程已被证实为改进工艺过程开发、优化和放大的方法提供多种好处。我指出的这一报告通过案例回顾审视了这些好处,包括了将工艺过程分析技术(PAT)用于:

  • 提供详细工艺过程知识,从而可以实时改进釜式结晶的产率、输出、和盈利
  • 通过改进过滤/干燥的表现消除下游工艺的瓶颈
  • 加速鉴别并定性分析关键操作变量,从而提高研发效率
  • 致使设计出更加可靠的工艺过程,从而确保批次间的稳定和满足晶体标准的一致性
  • 实时鉴别干扰和非理想事件,以助确保产品质量

另外,有一篇白皮书也讨论了此论题:釜式结晶从实验室到工厂的放大指南:用工艺过程分析技术更快地优化和解决问题

Process Analytical Technology at EuroPACT 2011

As I look ahead to 2011, an event of interest is EuroPACT 2011: the second European Conference on Process Analytics and Control Technology.  The EuroPACT 2011 event will be held April 26 to 29 in Glasgow.  Founded in 2006, the EuroPACT conference covers new technologies in process analytics and process performance monitoring, and the implementation of these technologies in various technological fields, including the transformation of data into knowledge, and industrial sectors.

One poster presentation that I wanted to highlight is – Faster Optimization and Troubleshooting with Process Analytical Technology: Real-time Measurement of the Crystal Population. Continue reading