Dr. Tidswell presented an excellent overview of viable but non-culturable (VBNC) organisms and their clinical implications and risk mitigation in sterile manufacturing. Of the estimated more than 1.5 million different microbial species, less than 0.1% are known to be culturable. He stated that media fills, environmental monitoring and finished product sterility testing may actually fail to capture all microorganisms that may be present, due to the use of growth-based, conventional assays. Therefore, Dr. Tidswell recommends the adoption of rapid non‐growth based, PAT microbiology methods to ensure a risk based, integrated approach to the assurance of asepsis, and to reduce our reliance on traditional sterility testing.
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