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Real-Time Release Testing

Unnecessary delays during pharmaceutical water monitoring have negative impacts on productivity and the ability to efficiently supply patients with the drug products they need. 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> respectively to online-based monitoring and release of Water for Injection (WFI)/Ultrapure Water (UPW) into production. In doing so, this eliminates the need to isolate and evaluate WFI/UPW grab samples in the lab on a frequent basis, streamlining the process by which water is released into production.?

Real-Time Release Testing

Unnecessary delays during pharmaceutical water monitoring have negative impacts on productivity and the ability to efficiently supply patients with the drug products they need. 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> respectively to online-based monitoring and release of Water for Injection (WFI)/Ultrapure Water (UPW) into production. In doing so, this eliminates the need to isolate and evaluate WFI/UPW 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.?

Portfolio

In addition to the instrumentation, software, and validation support that Sievers offers for real-time testing implementation, Sievers offers guidance in completing prerequisite and maintenance activities that apply to RTT.

Resources

Supporting documents COMING SOON.

Products

Products and services for Real-Time Release Testing?

Developing a successful plan for RTRT

There are different ways in which online TOC data can be used—process monitoring, process control, and process understanding. RTRT is validated to provide process monitoring, process control, and process understanding to release water into production in real-time. The process to be able to use an online instrument for the release of water into production can be broken down into phases.?

RTT Phases and Elements?

Phase 1: Organize and Define
  • Project scope and principles
Phase 2: Risk Assessment
  • Evaluate current and future states
  • Technology choice
  • Placement on water system
Phase 3: Implementation
  • Validation
  • Method transfer
  • Measurement System Equivalency
  • Comparability study?
Phase 4: Reporting and Data Handling
  • Data handling and reporting?
  • Alert and action limits?
Phase 5: Maintenance
  • Redundancy
  • Preventative maintenance?
  • Investigation procedures for OOS

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