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Effective microbial control is crucial for pharmaceutical companies to guarantee the safety of their products. Real-time, at-line bioburden analyzers offer ongoing insights into microbial contamination levels in water systems.
This case study highlights the integration of a METTLER TOLEDO 7000RMS™ microbial detection analyzer into a purified water system at a pharmaceutical firm, aimed at strengthening water quality management. The goal was to establish a solid baseline and define limits for the water system, ultimately providing enhanced bioburden control within their processes.
Even though pure water systems are low in nutrients, microorganisms can still exist in suspension and develop biofilms on internal surfaces. Pharmacopoeias mandate that these water systems be regulated to prevent the growth of microorganisms, as this is critical for ensuring the safety of pharmaceutical products and avoiding potential product recalls.
This case study explains how, positioned at the return point, the 7000RMS analyzer ensures process transparency and enables enhanced bioburden control within a pharma company's cold PW loop. The analyzer's continuous microbial contamination measurements are invaluable for process control and investigation. Furthermore, these measurements empower the facilities team to proactively address issues in the water system through heat sanitization. Without the 7000RMS, the team would likely miss numerous microbial-related incidents because traditional growth-based methods lack sensitivity.
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