Every year, contaminated pharmaceutical products put millions of patients at risk, leading to severe health consequences. HelioWaveTM offers next-generation rapid testing solutions, helping manufacturers meet complex and expanding safety demands.
Product Safety Assurance Deliver uncontaminated, high-quality products to your customers.
Custom Solution HelioWave adapts to your specific challenges, from pharmaceuticals to food safety and everyday goods.
Enhanced Customer Confidence Build trust by reducing recalls and ensuring product reliability across industries.
Faster Delivery Meet customer demands with optimized workflows that ensure on-time delivery of safe products.
Expert-Driven Success Partner with a team of innovators committed to helping you achieve your business goals.
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.