GE Analytical Instruments is leading the industry in implementing on-line TOC instrumentation for real-time release of pharmaceutical waters.

Real-time Release

Most pharmaceutical companies today release water for purified water (PW) and water for injection (WFI) using manual sampling and laboratory TOC testing. However, there are many advantages to using on-line TOC water testing over laboratory TOC analysis. Since on-line analyzers automatically collect samples directly from the water system, they eliminate the possibility of manual errors and sample contamination. In addition, the use of on-line TOC Analyzers demonstrates significant cost savings over traditional grab/laboratory analysis. Payback for a laboratory to on-line conversion is usually less than a year.

US FDA Supports Real Time Release Testing (RTRT)

In this recent interview, Christine Moore, Acting Director, Office of New Drug Quality Assessment, FDA, discusses the FDA's position on RTRT:

"Fear of the unknown" limiting adoption of real-time release testing, FDA says"
By Nick Taylor, 21-Nov-2011
Real-time release testing can save money by cutting recalls but "fear of the unknown" is limiting use, a FDA official said.
Watch full interview at: http://www.in-pharmatechnologist.com/Processing-QC/Fear-of-the-unknown-limiting-adoption-of-real-time-release-testing-FDA-says

Quality System Optimization™ and Real-time Release Testing

To help companies improve quality, reduce risk, and save money, GE Analytial Instruments offers the program, Implementing On-Line TOC Analyzers for Real-time Release, through the Quality System Optimization (QSO) professional services group. For more information, visit our QSO section.

The Sievers 500 RL On-Line TOC Analyzer works hand in hand with QSO. It was designed to help take the laboratory to the production floor. It is ideal for real-time release testing (RTRT) of pharmaceutical waters. Learn more about the Sievers 500 RL.