INTRODUCTION 序论序论 1 INTRODUCTION 序论 1.1 BACKGROUND 背景 The design, construction, and validation (commissioning and qualification) of water and steam systems for the pharmaceutical industry represent key opportunities for manufacturers, engineering professionals, and equipment suppliers. These systems ...
感谢共享，准确的说应该是 ISPE Baseline Volume4 ：Water and Steam System。
ISPE updates water and steam systems guide.The article reports on the publication of the U.S. International Society for Pharmaceutical Engineers' (ISPE) book entitled "ISPE Baseline Guide: Water and Steam Systems," Volume 4, Second Edition, in December 2011.EBSCO_bspManufacturing Chemist...
在ISPE基础制药工程指南(ISPE Baseline Pharmaceutical Engineering Guide Volume 4: Water and Steam Systems)中,关于总有机碳的控制要求,也对USP的相关规定给出了具体的描述。 USP虽未对目前为大家所接受的TOC检测技术做限制,但明确规定检测方式必须通过基于完全氧化法设计原理的分析仪器或设备来进行。 这些适用测量的...
ISPE Baseline Guide: Volume 4 - Water and Steam Systems ISPE Baseline Guide: Volume 5 ISPE ...
·Purified water (depending on how it is used), WFI, and clean steam normally arecategorized as Process Systems in that they are used in the manufacturingprocess itself.纯化水(取决于使用方式),注射用水和洁净蒸汽通常归类为工艺系统,因为他们用于制造工艺本身。
来自 EBSCO 喜欢 0 阅读量: 31 摘要: The article reports on the publication of the U.S. International Society for Pharmaceutical Engineers' (ISPE) book entitled "ISPE Baseline Guide: Water and Steam Systems," Volume 4, Second Edition, in December 2011. 年份: 2011 ...
Volume 4: Water and Steam Systems (Second Edition)? 卷4:水和蒸汽系统(第二版)? Volume 5: Commissioning and Qualification? 卷5:调试和确认? Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition)? 卷6:生物药品生产设施(第二版)? Volume 7: Risk-Based Manufacture of Pharmaceutical ...
Prove It 良好实践指南: 关键公用系统 GMP合规性 如何做到合规、 并可证明 Disclaimer: This Good Practice Guide is intended to provide guidance on achieving and maintaining critical utility systems compliance, and to be an aid to organizations in preparing and hosting regulatory inspections and audits....
Volume 4: Water and Steam Systems (Second Edition) 卷4:水和蒸汽系统(第二版) Volume 5: Commissioning and Qualification 卷5:调试和确认 Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition) 卷6:生物药品生产设施(第二版) Volume 7: Risk—Based Manufacture of Pharmaceutical Products (Ris...