Veolia水务技术与方案

制药用水实时放行检测

Unnecessary delays during pharmaceutical water monitoring have negative impacts on productivity and the ability to efficiently release drug products. Real-time release testing (RTRT) of pharmaceutical water exponentially enhances process efficiencies by migrating from laboratory-based total organic carbon (TOC) and conductivity monitoring in accordance with USP <643> and USP <645> to online-based monitoring and release of Water for Injection (WFI) and Purified Water (PW) into production. In doing so, this eliminates the need to isolate and evaluate WFI or purified water grab samples in the lab on a frequent basis, streamlining the process by which water is released into production. 

制药用水实时放行检测

Unnecessary delays during pharmaceutical water monitoring have negative impacts on productivity and the ability to efficiently release drug products. Real-time release testing (RTRT) of pharmaceutical water exponentially enhances process efficiencies by migrating from laboratory-based total organic carbon (TOC) and conductivity monitoring in accordance with USP <643> and USP <645> to online-based monitoring and release of Water for Injection (WFI) and Purified Water (PW) into production. In doing so, this eliminates the need to isolate and evaluate WFI or purified water grab samples in the lab on a frequent basis, streamlining the process by which water is released into production. 

Pharma 4.0

With pressure to meet increasing production demands, process analytical technologies (PAT) enable you to improve operational efficiencies and lean out processes. RTRT enables process understanding, process control, efficiency gains, and optimization to drive efficiency, all while ensuring precise, accurate, and robust data that aligns with data integrity requirements – ultimately lending itself to the Pharma 4.0 era. Learn about standard practices for Real-Time Release Testing (RTRT) of pharmaceutical water using online TOC and conductivity analysis in our eBook: TOC Technology Comparison Guide.

整体方案

Sievers可为实时检测提供仪器、软件和验证支持，除此以外还为完成适用于RTT的准备和维护活动提供指导。

资源

产品

实时发布测试的产品和服务

为RTRT制定一个成功的计划

在线TOC数据有不同的使用方式——过程监测、过程控制和过程理解。RTRT经过验证，可以提供过程监测、过程控制和过程理解，实时向生产中放水。能够使用在线仪器将水释放到生产中的过程可以分成几个阶段。

RTT阶段和要素

1阶段：组织和定义
  • 项目范围和原则
第2阶段：风险评估
  • 评估当前和未来的状态
  • 技术选择
  • 安装于水系统中
第3阶段：实施
  • 审定
  • 方法转移
  • 测量系统的等效性
  • 可比性研究
第4阶段：报告和数据处理
  • 数据处理和报告
  • 警报和行动限制
第5阶段：维护
  • 冗余度
  • 预防性维护
  • 对OOS的调查程序

 

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