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Domov Strokovna knjižnica Case Study on Process Control and Root Cause Analysis
Študija primera

Case Study on Process Control and Root Cause Analysis

Študija primera

With Real-time Microbial Monitoring

Process control
Process control

Microbial contamination monitoring for process control in the pharmaceutical industry in water for injection (WFI) or pure water (PW) has relied on laboratory-based methods developed a hundred years ago. These labor-intensive techniques require that lab personnel take samples manually, which are then used to determine if any colonies that form indicate microbial contamination.

This laboratory-based approach has a number of potential sources of contamination, even when handled by highly skilled personnel, including the sample port, sampling container and testing procedure.

A leading pharmaceutical company in France observed positive results on its laboratory-based testing method for microbial monitoring, leading to suspicion of microbial contamination in the water system. As a root cause analysis was being conducted, the company suspected that biofilm was forming in the system, leading to positive test results.

The plant turned to the METTLER TOLEDO Thornton 7000RMS Microbial Detection Analyzer to accelerate their analysis and obtain a more complete picture of their water system. Plant personnel used the new analyzer for real-time analysis of their water system for process control and to immediately identify any out of specification events. In addition, the 7000RMS allowed the plant to improve their sampling procedures and avoid false positive results.

Read in the case study how this allowed them to trace any event to specific actions in their water system.
 

Continuous monitoring with the 7000RMS enables constant and more accurate surveillance of a system’s water quality and overall process control, plus can be used to confirm sampling results. On-line monitoring enables early indication of microbial excursions so that process and quality groups can ensure water used for manufacturing is always in compliance.

The 7000RMS Microbial Detection Analyzer from METTLER TOLEDO provides results every two seconds to improve process control and production efficiency. Real-time monitoring eliminates waiting for results, which minimizes risk and reduces costs.