Microbial Challenge Test Results Of Purified Water

This fact sheet provides a summary of microbial test results obtained with the IMD-WTM-series instantaneous microbial detection™ system for water. The IMD-W system is a pharmaceutical water quality monitoring and risk management tool. This system has been designed for the routine monitoring of Purified Water (PW) and Water for Injection (WFI) systems, including distribution loops, storage tanks and points-of-use (POU). The IMD-W system can be used to continuously monitor a pharmaceutical water loop and in conventional point sampling applications. Challenge organisms were chosen based on guidance provided in the United States and European Pharmacopeias, and by the Online Water Bioburden Analyzer (OWBA) working group.A Testing was designed to show the capability and sensitivity of the IMD-W system in detecting planktonic (single, free-floating) microorganisms through the assessment of ten industry relevant organisms.