The Significance and Detection of VBNC Microorganisms

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The true significance of VBNC organisms to the pharmaceutical industry is only just beginning to emerge. The real risk to patients from undetected VBNC organisms in the pharmaceutical products is limited.This is due to the range of antimicrobial processes involved in the pharmaceutical manufacturing. However, the real significance of VBNC is likely to be in helping us understand more about current and future industrial processes. If we can get more information about true levels of viable organism in raw materials, water and the manufacturing environment, we are a great deal closer to gaining a greater understanding of manufacturing processes. Emerging alternative technologies may help play a role in significantly improving the quality of pharmaceutical products in the future by increasing our process knowledge. New methods of enumeration and identification with the potential for detecting VBNC organisms may bring about a radical reappraisal of bioburden limits, and environmental monitoring techniques and limits.

This paper discusses and compares many detection methods including:

• Direct counting methods
• Dye reduction tests
• Immunological-based methods
• Genetic methods
• ATP bioluminescence
• Fluorescent labeling methods
• Optical fluorescenc

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