HelioSAFETM is designed for pharmaceutical production workflows that demand rapid turnaround times, particularly in areas such as cell therapy, gene therapy, radiopharmaceuticals, and other personalized medicines.
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 designed to meet the requirements of USP <71> for sterility testing. A Drug Master File (DMF) submission to the FDA is currently in progress and is expected to be completed by Q3 2025.
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.