Non-Growth Based Alternative Sterility Testing
This technical brief addresses the appropriate response to an out-of-specification sterility test when using a non-growth based rapid microbial method such as the SCANRDI® System that utilizes solid phase cytometry.
The SCANRDI® is a non-growth-based rapid microbial method (RMM) that detects not only viable microbial cells that can be isolated using a broth or agar plate but also viable but non-culturable (VBNC) microorganisms, including stressed and fastidious microorganisms that may not be recovered by standard culture methods, making SCANRDI more sensitive than growth-based methods.
The FDA has indicated that there are approved drug applications using the SCANRDI® for sterility tests for product release. Therefore the technology is accepted in the pharmaceutical industry.
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