文档介绍：ISPE 2009 Washington Conference
1-4 June 2009
Washington . USA
当前无菌生产技术的发展趋势
PIE China Conference –
Charlotte Enghave Fruergaard on behalf of
Hartmut Schaz
内容:
•简介
•当前的法规情况
- 欧盟GMP附录一和PIC关于西林瓶加胶塞问题的建议
•技术趋势
- 市场的变化迫使技术要进行变更…
- 屏障系统
- 灌装
- 冻干装载和卸载技术
- 灭菌技术
- 胶塞工艺技术
- 清洁技术
- 一次性系统
•总结
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1
ISPE 2009 Washington Conference
1-4 June 2009
Washington . USA
内容:
•简介
•当前的法规情况
- 欧盟GMP附录一和PIC关于西林瓶加胶塞问题的建议
•技术趋势
- 市场的变化迫使技术要进行变更…
- 屏障系统
- 灌装
- 冻干装载和卸载技术
- 灭菌技术
- 胶塞工艺技术
- 清洁技术
- 一次性系统
•总结
Slide 3 of 39
Introduction
介绍Hartmut Schaz
Hartmut Schaz 拥有德国Sigmaringen 应用科学大学制药工
程专业硕士学位。从1991年他开始工作开始,他负责在15个
以上的国家从事计划和制药厂试驯鹰工作。
他在无菌操作方面有重要的知识,定期在国际工程会议上演
讲。
目前,他在NNE Pharmaplan作为小容量注射产品高级专家
并且他还是NNE Pharmaplan印度公司的董事.
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2
ISPE 2009 Washington Conference
1-4 June 2009
Washington . USA
Introduction
Charlotte Enghave Fruergaard
Dr. Charlotte Enghave Fruergaard is employed as Director
of Technology – Finished Pharma at NNE Pharmaplan in
Denmark. Charlotte has 16 years of experience with
pharmaceutical projects with a broad experience within
pharmaceutical manufacturing of Sterile Products.
Charlotte holds a . in mechanical engineering and a
. in measuring technique from the Technical
University of Copenhagen.
Charlotte is the current Secretary on the International
Board of Directors of ISPE. She is co-founder of the ISPE
Nordic Affiliate in 2000, and was Chairman of the Nordic
Affiliate for the period 2006-2007. She is an active member
of several mittees and has been the co-chairman
of the yearly urring ISPE “Barrier Isolation
Technology Conference” in Europe since 1999.
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内容:
•简介
•当前的法规情况
- 欧盟GMP附录一和PIC关于西林瓶加胶塞问题的建议
•技术趋势
- 市场的变化迫使技术要进行变更…
- 屏障系统
- 灌装
- 冻干装载和卸载技术
- 灭菌技术
- 胶塞工艺技术
- 清洁技术
- 一次性系统
•总结
Slide 6 of 39
3
ISPE 2009 Washington Conference
1-4 June 20