Onshoring Innovation - Rapid Sterility Testing

With our passion to advance the next generation of manufacturing in Australia through the onshoring of innovation, CBE Pure Solutions is excited to announce that we are developing rapid microbiological methods to cut sterility turnaround times to 2 days from the traditional 2 weeks. CBE Pure Solutions is utilising bioMérieux’s world-leading technology SCANRDI® platform.

Rapid Sterility Microbiology Methodology (RSMM) in action, utilises a viability dye for detecting microbial contaminants in a filterable product- the dye labels living microbes captured by a filter membrane through which product has passed. The "viability substrate" component of the labelling solution enters the microorganism through the cell membrane. 

Living cells cleave the non-fluorescent viability substrate by an enzymatic reaction, releasing fluorescent particles (free fluorochrome) within the cell. The cell's membrane holds the light-emitting fluorochrome within the cell and allows it to be detected by the SCANRDI®'s laser. Nonliving cells are not metabolically active and are not labelled. These stained microbes are then detected by an image analyser, and their presence is confirmed microscopically by our trained microbiologist. Our RSMM product specific methodology confirms sterility of product within two days and is not dependent on slow growth procedures (at least 14 days) using chemiluminescent technology.

RSMM is specifically tailored to your product. Additionally, these methodologies can also be developed for quantitative analysis of filterable samples e.g. WFI where a quick turnaround result is required.

RSMM enables you to release product to patient in critical time under a fully validated and compliant methodology.

If you would like further information on how RSMM works or can improve your business, please contact CBE Pure Solutions.