New Program for Implementing On-Line TOC Analyzers for Real-Time Release of Pharmaceutical Water

February 1, 2010 - Boulder, CO - GE Analytical Instruments, part of GE Power and Water and a leading manufacturer of Total Organic Carbon (TOC) analyzers to the pharmaceutical industry, announces a new program, Implementing On-Line TOC for Real-Time Water Release (RTR). This program is designed for pharmaceutical companies seeking to improve quality and reduce costs by moving from laboratory-based water quality testing to continuous on-line testing and real-time water release (RTR). GE’s science- and risk-based program simplifies and accelerates this traditionally complex and lengthy transition. the QSO/RTR section of this site.

Implementing On-Line TOC for Real-Time Water Release is part of GE Analytical Instruments’ Quality System Optimization (QSO)™ service offering. For short, the RTR program is called QSO/RTR. QSO/RTR provides a framework for transitioning TOC testing from the laboratory to the production floor. It incorporates Lean manufacturing and Six Sigma® best practices, aligned with current Good Manufacturing Practices (cGMPs) and regulatory guidance. QSO/RTR provides a practical roadmap on how to evaluate variability and identify opportunities for improvement in TOC sample analysis processes.

"We developed this program to help pharmaceutical manufacturers deliver a science-based, efficient approach to RTR process validation using on-line TOC measurements.” said Stephen Poirier, V.P. of Business Development for GE Analytical Instruments. “ Historically, technicians have taken manual grab samples from the water system and brought them to the laboratory for TOC measurement. This process is very labor-intensive and time-consuming. Our experience is that manufacturers can expect to reduce lab sampling costs by up to 80% by moving most of their laboratory-based TOC testing to the on-line environment.”

The QSO/RTR program has four main components: a one-day introductory workshop,process validationprotocols, validation services, and a consulting service. Each component is available separately or with the complete QSO/RTR program. With the consulting service, an expert GE facilitator will guide the pharmaceutical company’s cross-functional team through several critical process design decisions using state-of-the-art analysis tools and risk-based decision processes to arrive at the desired RTR state. The complete program is designed to guide organizations through the RTR process in less than six months.