Advanced Sterilization Capability with Low Environmental footprint for Patient Infection Optimized Safety

Introduction

The MedTech industry is facing the emergence of innovative single-use and reusable medical devices (MD) with ever more complex forms and sensitive components in need of optimal safety conditions for sterilization. However, hospitals face problems with chemicals, radiation, and limited sterilization options, leading to compromises in patient safety and potential device contamination. Over 20% of endoscopes are tainted.

Challenges in the MedTech Industry

Similarly, MD manufacturers encounter technological, environmental, and health obstacles, which can limit production capacity and endanger patients' lives. Regulatory and political pressures are growing to eliminate the use of ethylene oxide (EtO), and current technologies face challenges in capacity and compatibility with MD materials, reducing the resilience of MD production.

AURORA's Innovation

In this context, AURORA has developed the first In Situ Cold (non-Thermal) Plasma Sterilization technology for MD that turns air gases into plasma and doesn’t use any chemicals, radiation, nor leave any potentially harmful residue. This breakthrough process, able to destroy all biothreats, is designed to meet the needs of both hospitals and MD manufacturers for better safety standards for patients and staff, as well as environmental protection.

ASCLEPIOS Project Overview

ASCLEPIOS will materialize 12 years of R&D programs aimed at validating the feasibility of its cold-plasma sterilization process and developing its efficacy on the full range of biothreats, including:

1. Spores
2. Viruses
3. Bacteria
4. Biofilms

This project will ensure compatibility with fragile MDs, representing key assets towards unlocking early technical and economic barriers to commercial exploitation.

Technology Readiness Level (TRL)

While TRL6 has been successfully passed, the ASCLEPIOS proposal will allow reaching TRL9. This last step will enable the technology to be deployed Europe- and US-wide, creating strong economic activity, replacing current solutions, and thus meeting social, health, and environmental challenges. It will also establish a strong European leadership in this new field.