ISPE_9.仪器和控制.doc

INSTRUMENTATION AND CONTROL 仪器及控制 9. INSTRUMENTATION AND CONTROL 9. 仪器及控制 9.1 INTRODUCTION 9.1 简介 Instrumentation and controls are often used within pharmaceutical water systems to: 通常用制药水系统中的仪器及控制来： ? control the operation of equipment and components 控制设备和组件的运行 ? monitor and document the performance of critical equipment 监控并用文件记录关键设备的性能 ? monitor and document pharmaceutical water quality 监控并用文件记录制药用水的质量 The concepts and regulatory philosophy of defining critical versus non-critical parameters is discussed as it relates to instrumentation and controls. This definition could be summarized as: 当它关系到仪器和控制时，就要讨论关键和非关键参数的概念和调控原则了。定义可以总结如下： All instruments and control systems should be commissioned following Good Engineering Practices. Critical instruments and control systems should be commissioned and qualified. “所有的仪器和控制都应当遵循良好工程规范来进行委认。关键的仪器和控制系统应当进行委认及资格验证。” There is no regulatory requirement that requires the use of On-Line instrumentation. A monitoring program may include a combination of On-Line instrumentation, manual documentation, and laboratory analysis. 没有法规要求命令使用在线仪器。监测程序可能是在线仪器、文件手册及实验室分析的一个结合。 If On-Line instrumentation is used to measure or record a critical parameter, action and alert limits may be established. The methods of addressing spikes are also discussed. 如果用在线仪器来测量或记录关键参数，可以建立行为及警报限。显示“峰形”的方法也要讨论。 Automation can have a significant impact on the cost and performance of a pharmaceutical water system. There is no single optimum level of instrumentation and control for all systems. The optimum level for a given system balances the benefits of improved process control, improved documentation, and lower labor costs against the cost of procuring, installing, validating, and maintaining the instruments and control systems. In many cases, the level of automation for a pharmaceutical water system should be consistent with that utilized for the manufacturing process it supports. 自动化会对制药水系统的成本及性能产生显著影响。对所有系统而言，仪器和控制并没有一个单一的最佳水平。给定系统的最佳水平是利益平衡，利