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13th November 2023  Content supplied by: bioMérieux (Industry)

The Crucial Role of a Rapid Sterility Test in Enhancing Water Analysis

Why Should You Consider Rapid Microbiological Methods (RMM) for Water Testing in Pharmaceutical Manufacturing?

In pharmaceutical manufacturing, particularly in microbiology, testing Water for Injection (WFI) is vital, now complemented by Rapid Microbiological Methods (RMM). SCANRDI® is a successful example, with ultra-rapid detection offering key advantages, including:

  • Quicker Results: SCANRDI® provides ultra-rapid results.
  • Early Contamination Detection: It can detect contamination at an early stage.
  • Heightened Sensitivity: It is highly sensitive to even minor issues.
  • Reduced Margin for Human Error: With RMM, the risk of human error is minimized.
  • Resource Efficiency: RMM makes better use of resources.

These benefits significantly contribute to the overall reliability and efficiency of pharmaceutical manufacturing processes. This importance is driven by two primary factors:

  1. Patient Safety: WFI is critical in drug formulations, and any microbial contamination poses serious risks. Bacteria, molds, or fungi can compromise product efficacy and jeopardize health. Rigorous microbiological testing, often enhanced by RMM, is vital to ensure WFI remains free from harmful microorganisms.
  2. Regulatory Compliance: The FDA and EMA mandate stringent microbiological standards for WFI. RMM is recognized as a reliable way to meet these legal requirements. Non-compliance can lead to fines and product recalls. WFI's microbiological quality significantly affects product stability, shelf-life, and potency. Efficient testing with RMM is essential to maintain product effectiveness and integrity.

Read more information about SCANRDI or use the Request Information button to make contact with the supplier.


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Date Published: 13th November 2023

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