Alternative Rapid Microbial Method

Choosing the right rapid microbiological method (RMM) for a particular quality control process requires evaluating not just the technical benefits and drawbacks of available technologies, but also their contribution to the business through return on investment. Current rapid methods on the market tend to carry much higher upfront costs than compendial methods, which may limit their implementation in many applications. Zymeron develops an alternative rapid sterility testing method that delivers results under 30 minutes.

Rapid Microbiological Method

μSTF is an alternative rapid microbiological method based on lab-on-chip technology, ideal for sterility testing in biomanufacturing with less than 30 minutes of sample-to-result. μSTF has single-cell resolution, i.e. limit of detection is one microbial cell per sample. It is a nongrowth method, does not require any enrichment, culturing, staining, or incubation step. It is so rapid to provide near real-time, qualitative presence/absence readout.

μSTF can be used for any filterable product, for screening purpose to save time and money. The detection process is non-destructive, preserving the microbial contaminants from a positive screening test for further analysis including organism identification and strain typing if needed. Faster time to result enables manufacturers quicker product release to market, shorten the production cycle, improve productivity, free up working capital, and achieve greater return on investment.

μSTF is an automated, closed system requiring minimum training. The system is based on lab-on-chip detection technology and miniaturized instrumentation technique, and it is cost effective requiring very low upfront capital investment. Full automation from sample to result also eliminates inaccurate results induced by operator variations.

Compared to RMMs that require pre-enrichment such as nucleic acid amplification and metabolic markers, and cytometry-based methods that rely on expensive instruments, Zymeron’s μSTF is the best in class.