2014API工艺研发PAT(过程分析)技术交流会(成都)
作者:pharmchem    发布于:2014-03-22 07:18:58    文字:【】【】【
摘要:过程分析技术(Process Analytical Technology,简称PAT)在医药化工行业越来越受到重视,包括美国FDA在内的官方机构正在积极推动应用PAT技术,力图实现QbD(质量源于设计)理念,“产品质量是通过设计赋予的,而不是通过最终产品检测出来的”。PAT已经成为规范生产过程最优化的有效工具,确保规模生产的产品质量,在提高效率的同时减少质量降低的风险。

2014API工艺研发PAT(过程分析)技术交流会(成都)

2014’ PAT (Process Analysis) Seminar of API Production Techniques

 


主办单位:北京中联天鸿化工信息中心 

 国药励展

Organizers: BeiJing ZhongLian TianHong Chemical Information Centre

           Reed Sinopharm Exhibitions Co., Ltd.

支持单位:梅特勒-托利多自动化化学部

Sponsor: Mettler-Toledo AutoChem

会议时间:2014522 9:2012:00 AM

Time: 9:2012:00, MAY. 22th, 2014 AM

会议地点:成都世纪城新国际会展中心

Venue:

会议背景:

    近年来,国家从战略和政策层面不断加大对医药化工产业的支持力度,整个医药化工产业正面临着历史性的发展机遇。同时在新形势下,医药化工企业将面临解决技术升级、规范生产工艺、提高产品质量、治理环境与安全等优化生产过程的技术与工艺控制过程的各种问题,以确保最终商业化生产过程在新版GMP要求的条件下进行。近年来,过程分析技术(Process Analytical Technology,简称PAT)在医药化工行业越来越受到重视,包括美国FDA在内的官方机构正在积极推动应用PAT技术,力图实现QbD(质量源于设计)理念,“产品质量是通过设计赋予的,而不是通过最终产品检测出来的”。PAT已经成为规范生产过程最优化的有效工具,确保规模生产的产品质量,在提高效率的同时减少质量降低的风险。但是PAT作为是一个新的技术、理念和方法,在国内发展比较晚。

会议内容:

Contents

化工工艺本质安全化设计与评估的若干问题  9:20-10:20 AM

Several Problems on Evaluation and Design of Inherent Safety Chemical Process 

南京理工大学化工学院安全工程系 陈网桦 教授

Department of Safety Engineering, School of Chemical Engineering, Nanjing University of Science and Technology  Chen Wanghua  Professor & Director

嘉宾简历:陈网桦教授。南京理工大学教授,博士生导师。全国高等学校安全工程教学指导委员会委员;中国兵工学会爆炸与安全专业委员会委员;中国安全生产协会专家组石油化工组成员。主要研究领域为化工工艺热危险性分析与控制、爆炸与安全防护、安全评价技术。从2000 年至今,主要围绕各种危险化学物质的安全(尤其是热安全问题)进行研究。目前在化工工艺热安全领域,合作出版《安全原理与危险化学品测评技术》及《化工工艺热安全-风险评估与工艺设计》(译著),发表/合作发表论文50余篇,已培养博、硕士研究生20 名。

Prof Wanghua Chen, Ph.D instructor of Nanjing University of Science & Technology. Vise director of National Specialty Committee of Explosion and Safety. Member of National Teaching Instruction Committee of Safety Engineering Discipline. Member of expertise group of National Bureau of Management and Supervision of Safety Production. Expert of petrochemical group of China Association of Work Safety. His research areas are safety techniques on chemical process, especially in hazardous materials, deflagration of dust, gas and vapor, runaway chemical reaction (thermal safety of chemical process), techniques on explosion and its engineering protection, and techniques on risk analysis and assessment. From 2000 to the present, worked in safety techniques on hazardous materials and thermal safety of chemical reaction process by thermal analysis equipments such as differential scanning calorimeter (DSC), accelerating rate calorimeter (ARC), Calvet Calorimeter (C80-D) and reaction calorimeter (RC1e). Now, in the field of thermal safety of chemical process, he has cooperated and published a translated book (from English ed. to Chinese ed.) Thermal Safety of Chemical Processes —— Risk Assessment and Process Design and a book Safety Principles, Techniques on Measurement and Assessment of Hazardous Materials, Chem. Eng. Press. 2004, published more than 50 academic papers, and more than 20 Ph.D or M.D were under his instruction and graduated.

 

 

 

 

应用过程分析技术(PAT)进行API合成与结晶工艺的开发和优化 10:20-11:20 AM

Developing and Optimizing API Chemical and Crystallization Processes with Efficient PAT Tools刘慧敏,梅特勒-托利多中国自动化化学部产品经理

Liu Huimin, Product Manager of Mettler-Toledo Autochem China

嘉宾简历:刘慧敏,博士,梅特勒-托利多自动化化学部产品经理,高级技术应用顾问。毕业于天津大学,获化学工艺博士学位,曾赴美国南伊利诺伊大学博士后研究,主要从事有机合成, 工艺优化研究。近年来一直从事在线分析技术的应用咨询和实践工作,对应用PAT技术进行化学合成工艺和结晶工艺开发和优化积累了一定的经验。电话:18616778997E-mail:Selina.liu@mt.com

Biography: Huimin Liu, PhD in Organic Chemistry, graduated from Chemistry Department and did postdoc research in Department of Chemistry and Biochemistry in Southern Illnois University. Since the end of 2007, she joined in METTLER TOLEDO as a Technology Application Consultant. Now she works as the product manager, focus on the application and marketing development of the process analysis technology for Chemical and Crystallization Processes.

 

 

 


制药工业中的结晶技术  11:20-12:20 AM

Crystallization Technology in Pharmaceutical Industry 

龚俊波 副教授,博士生导师,国家工业结晶工程技术研究中心副主任

Junbo Gong Associate Professor, Vice director of National Engineering Research Center of Industrial Crystallization Technology

 

嘉宾简历:天津大学化学工程博士,美国密歇根大学药学院博士后,从事工业结晶特别是药物结晶的科学与技术方向的研究近20年,针对制药工业中的结晶问题,开展药物晶体工程学、工业结晶过程分析以及产业化工程放大与设计的多尺度机制关联与调控的技术与装备研发,发表学术论文70余篇,参编专著4部,申请和授权发明专利近30,负责国家和省部级项目以及企业产学研合作项目近40项,负责完成5条现代医药结晶生产线。

Biography: Ph.D of Chemical Engineering, Tianjin University,

postdoctoral Research in School of Pharmacy, University of Michigan, USA

Dr. Gong has engaged in science and technology research of industrial crystallization, especially pharmaceutical crystallization for nearly 20 years. Aiming at crystallization problem in pharmaceutical industry, Dr. Gong and his group are focused on crystal engineering, process analysis, scale up and crystallizer design to meet the requirements of product engineering and process engineering. Till now, Dr. Gong has published has published more than 70 academic papers and was compiler member for 4 books. Also, Dr. Gong has nearly 30 issued patents and patent applications and is responsible for about 40 national and provincial projects and enterprises cooperative projects. Based on scientific and technologic research of pharmaceutical crystallization, Dr. Gong’s group built 5 modern pharmaceutical crystallization production line were built.

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