Process Control with Microbial Detection

This white paper explains five process control advantages of at-line microbial monitoring. The pharma industry and its regulators acknowledge and endorse the need for the ability to monitor bioburden contamination in real-time for more effective responses to changes in water quality.

For pharmaceutical manufacturers, on-line measurement allows for more efficient responses to water quality challenges. Total Organic Carbon (TOC) and conductivity are two key process analytic parameters where on-line/at-line measurements have been possible for decades. However, when it comes to monitoring bioburden contamination in high purity water, the market has relied on laboratory-based methods developed over a century ago. Integrating at-line bioburden measurement offers significant advantages in process control.

METTLER TOLEDO Thornton’s 7000RMS™ Microbial Detection Analyzer is an innovative solution to the industry’s need for better process control of bioburden. The 7000RMS provides real-time data and process transparency into the dynamics of a facility’s water system, allowing proactive monitoring of microbial contamination. This technique has the ability to provide bioburden counts as frequently as every two seconds, or 1 mL of sample stream, making it possible to observe any excursions as they happen. Ultimately, the 7000RMS increases process control, reduces risk and allows for greater sensitivity of bioburden measurements, while reducing costs and increasing productivity.