Hot Water for Injection
Sanitization and the development and existence of bioburden in pharma water systems is often misunderstood. This white paper looks at the effectivity of hot Water For Injection (WFI) systems and the 7000RMS on-line microbial detection analyzer for bioburden monitoring in pharma water.
While the pharma industry makes an effort to control and eliminate bioburden, traditional sanitization methods are not 100% effective at accomplishing this.
For decades, the pharmaceutical industry has been searching for Rapid Microbial Methods, and in recent years several new rapid tests have been introduced for sterility, air and pharmaceutical water. Adoption of new Rapid Microbial Methods in the pharmaceutical industry requires not only the acceptance of the tests, but an understanding that the new tests provide real-time data for improved process control. This white paper explains the current test used to detect endotoxins and the limitations of the traditional plate count method.
The METTLER TOLEDO Thornton 7000RMS™ is an on-line microbial detection analyzer. It provides the real-time data and information necessary for monitoring a water system and determining if it is under control. In addition, its measurement technology identifies the presence of bioburden in situations where plate count methods are unreliable. The 7000RMS can confidently be used for ascertaining if water system sanitization procedures are sufficient and effective, and if the maintenance cycle is frequent enough to maintain the required water quality and therefore, reduces risks to products.