Marcel Dion, Director of Marketing, Washing and Sterilization Systems, STERIS and George Verghese, Director of Technical Services STERIS to present at INTERPHEX 2012

“ On-line TOC Monitoring in GMP Parts Washers”

May 2, 2012

TOC (total organic carbon) analysis is one of the most common analytical methods used for cleaning validation in the pharmaceutical industry. This nonspecific method is typically used to detect the presence of organic residues on cleaned product contact surfaces. In automated cleaning systems, a sample of the final rinse water is analyzed for TOC off-line. This approach requires that a sample be manually taken from the washing system and transferred to a laboratory for TOC analysis. A new technology is now available that allows this process to be performed by the washing system itself. The system greatly reduces the risk of contaminating rinse water samples by minimizing manual intervention, and provides immediate analysis results. Any deviation from defined acceptance criteria is immediately detected by the washer control system. This allows for faster release of cleaned parts for manufacturing and can reduce equipment downtime. Participants will learn how this approach can reduce the labor and associated operational costs, and understand how such a system can increase overall equipment uptime and streamline the design of an efficient and robust cleaning process that meets PAT and QbD goals.