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HelioSAFETM utilizes a label-free, non-destructive analytical method that identifies passing microbes based on their unique electrical response signatures. With single-cell resolution, HelioSAFETM is capable of detecting contaminants at concentrations as low as a single microbial cell.
Yes, HelioSAFETM is an agnostic detection platform, compatible with a wide range of microorganisms, including bacteria, fungi, and endospores.
HelioSAFETM is being developed and validated in accordance with USP <1223> guidelines for alternative microbiological methods, with USP <71> serving as the reference standard for sterility testing. HelioWave has submitted an initial Drug Master File (DMF) to the FDA and plans to collaborate with industry partners to update the DMF with additional workflow-specific suitability data by mid-2027.
The current HelioSAFETM system is designed as a standalone benchtop unit. However, future iterations are being developed for at-line and in-line integration to support continuous manufacturing environments. We are actively collaborating with industrial partners to advance this development.