期刊文献+

基于ISA S88的批处理控制系统在包衣机中的应用

The Application of ANSI/ISA S88 Based Batch Control System to the Hi-coater
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摘要 论文基于某跨国制药企业上海工厂的包衣机转移改造项目,深入研究基于ISA S88(以下简称S88)的批处理系统在包衣机中的应用,配合相关的计算机化系统验证,探讨以模块化的解决方案实现高效、柔性化以及GMP合规的新型包衣机自动化控制系统。 : This article, based on Hi-coater revamping project of Shanghai ficility of a world famous pharmaceutical company, will study in depth of the application of ISA S88 (referred as S88) based batch control system to the High-coater. Along with the associated computerized system validation, a new generation automated control system, which is more efficient, flexible and fully GMP compliant shall be achieved.
作者 王培栋
出处 《机电产品开发与创新》 2013年第4期45-47,共3页 Development & Innovation of Machinery & Electrical Products
关键词 ISAS88 批处理控制系统 包衣机 计算机化系统验证 GMP ISA S88 batch control system high-coater computerized system validation GMP
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参考文献6

  • 1ANSI/ISA. ISA-$88.01-1995, Batch Control Part 1: Models and Terminology[S]. ISA, 1995.
  • 2ANSI/ISA. ISA-$88.00.02-2001, Batch Control Part 2: Data and Guidelines for Language[S]. ISA, 2001.
  • 3U.S. Food and Drug Administration.Guidance for Industry, Part 11, Electronic Records, Electronic Signature - Scope and Application[Z]. US: Food and Drug Administration, 2003.
  • 4U.S. Food and Drug Administration. Electronic Records, Electronic Signatures 21 CFR Part 11[Z]. 1997.
  • 5Rockwell Automation. FactoryTalk Batch Technical Reference Guide Volume I[Z]. US: Rockwell Automation, 2011.
  • 6SAE International. Control System Software Testing and Validation [M]. US: SAE, 2005.

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