" SalamanderU and Solidfog Technologies are two companies with expertise in innovative customised containment solutions and industrial biotechnology operations, and the second specialises in airborne surface decontamination systems (hydrogen peroxide - H2O2 nebulisation). They have collaborated to provide a simple and robust operational solution for the decontamination of FFP2 masks in large quantities and to be installed directly within the hospital environment. The solution consists of a "CleanBubble®" containment chamber, which can be assembled in less than half an hour, consisting of a flexible envelope attached to an aluminium structure, a vacuum unit equipped with a HEPA filter and a "DosyMist®" decontamination unit that generates an H2O2 mist. This containment chamber is also equipped with the digital "SmartReg®" solution which vocally controls the operators during disinfection and automatically generates a decontamination report. The solution allows to disinfect up to 350 FFP2 masks in a 6-hour cycle. THE DECONTAMINATION CYCLE OF 350 MASKS IN 6 HOURS This solution, which combines decontamination and containment management expertise from recognized suppliers in the pharmaceutical industry, is an industry-standard solution. It allows the decontamination of 350 masks in 6 hours, i.e. more than 1,000 masks in one day (potential of 3 cycles per day) with a minimum human intervention of less than 2 hours as it is limited to placing the masks on the CleanBubble® racks, starting the decontamination cycle and removing the masks from the CleanBubble®. THE IMPLEMENTATION The installation of the decontamination unit and its use is possible within 3 days; the unit can be installed in places as diverse as a corridor, a storage place, a hall and requires only an ordinary power supply to start disinfection. It is a simple solution including the "CleanBubble®" containment area, the "DosyMist®" decontamination station and mask positioning supports. The vocal piloting of the operations by the digital solution "SmartReg®" offers a complete and fast autonomy by only one operator while a report of the operations is generated at the end of the cycle. BENEFITS OF THE SOLUTION The very competitive cost price of mask processing is significantly lower than a new FFP2 mask. salamanderU and Solidfog Technologies have a dozen units available ready for rapid deployment. This solution, which combines several areas of expertise, can also handle the decontamination of medical devices. EFFICIENCY OF THE SOLUTION salamanderU and Solidfog Technologies have developed and deployed a validation protocol for the simultaneous decontamination of 350 FFP2 masks. This validation is based on pharmaceutical processes. It demonstrates the effectiveness of decontamination and the maintenance of mask performance after exposure to H2O2. It complies with the guidance issued by the Federal Agency for Medicines and Health Products (FAMHP): "Guidance for the reprocessing of surgical masks and filtering facepiece respirators (FFP2, FFP3) during the Coronavirus disease (COVID-19) Public Health Emergency". At this stage, 3 validation cycles have been carried out and the results given by the chemical and biological indicators meet the requirements. It should be noted that the relevance of our solution is reinforced by the tests approved by the American FDA authorities. These studies confirm the effectiveness of H2O2 disinfection and the maintenance of mask performance after 30 decontamination cycles. The effectiveness of decontamination of FFP2 masks in large quantities has been fully demonstrated. "
Claude Dedry, CEO