Home/Biodecontamination/SalamanderU and Solidfog Technologies join forces to develop FFP2 mask decontamination systems

SalamanderU and Solidfog Technologies join forces to develop FFP2 mask decontamination systems

SalamanderU and Solidfog Technologies, represented in Spain by Netsteril, S.L., have come together to jointly develop a solution to the problem of shortages of FFP2 and FFP3 protection masks in the fight against the Covid19 pandemic.

SalamanderU and Solidfog Technologies are 2 Belgian companies with a strong innovation component. SalamanderU is dedicated to the development of isolation or containment systems, integrating advanced control and registration systems, such as voice and video recording in the field of aseptic operations in the pharmaceutical and biotechnology industries. Solidfog is a company 100% focused on airborne surface decontamination systems by dry-fogging of hydrogen peroxide (VH2O2).

The two companies, facing the challenge posed by the Covid19 pandemic in the entire healthcare system, have gotten down to work and have collaborated to provide a simple and robust solution for the decontamination of FFP2 masks in large quantities, which can be directly installed into the hospital environment.

The solution integrates two technologies that both companies already had developed. On one hand, a “CleanBubble®” containment chamber, consisting of a flexible envelope attached to an aluminium frame and a ventilation unit equipped with a HEPA filter. This structure can be assembled in less than half an hour. On the other hand, a “DosyMist®” decontamination unit that generates a dry mist of H2O2, which is homogeneously distributed throughout the environment while vaporizes, creating an atmosphere that destroys all kinds of microorganisms, including the Sars-cov-2 virus. The most innovative feature of this solution is the use of new technologies such as the “SmartReg®” system, which allows operators to control and record by voice the steps to follow when performing disinfection, automatically generating a decontamination report.

A 6 HOUR DECONTAMINATION CYCLE WITH CAPACITY FOR 350 MASKS

This solution, which combines the experience and technical solvency of both companies, widely recognized in the pharmaceutical industry, is an industrial-type solution. It allows, in 6 hours, the decontamination of 350 masks, or more than 1000 masks in a day (with a potential of 3 cycles per day) and this with a minimum human intervention, of less than 2 hours, since it is limited to putting the masks on the “CleanBubble®” racks, start the automatic decontamination cycle and then remove the masks from the “CleanBubble®”.

Solidfog FFP2 mask disinfection system IMPLEMENTATION

The installation and commissioning of the decontamination unit is possible in just 3 days. The unit can be installed in places as diverse as a hallway, a warehouse, a hall, etc. It only requires an electrical outlet to start disinfection. The solution is simply the “CleanBubble®” chamber, the “DosyMist®” decontamination equipment and the racks to place the masks. Voice control of operations using the “SmartReg®” digital solution offers complete and fast autonomy by a single operator while generating an operation report at the end of the cycle

The solution integrates two technologies that both companies already had developed. On one hand, a “CleanBubble®” containment chamber, consisting of a flexible envelope attached to an aluminium frame and a ventilation unit equipped with a HEPA filter. This structure can be assembled in less than half an hour. On the other hand, a “DosyMist®” decontamination unit that generates a dry mist of H2O2, which is homogeneously distributed throughout the environment while vaporizes, creating an atmosphere that destroys all kinds of microorganisms, including the Sars-cov-2 virus. The most innovative feature of this solution is the use of new technologies such as the “SmartReg®” system, which allows operators to control and record by voice the steps to follow when performing disinfection, automatically generating a decontamination report.

ADVANTAGES OF THE SOLUTION

Mask treatment can be performed at a very competitive cost, significantly less than that of a new FFP2 mask. SalamanderU and Solidfog currently have a dozen units available ready for rapid deployment. This solution, which combines various skills, can also handle the decontamination of other medical devices such as respirators and others, after evaluating their design and materials.

Dosysmit decontamination unit
EFFECTIVENESS AND NORMS

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 standards, required in Correct Manufacturing Standards (GMP). With validation, the effectiveness of decontamination and maintenance of mask performance after exposure to H2O2 is demonstrated and documented.

Furthermore, it complies with the guide issued by the Federal Agency for Medicines and Health Products (AFMPS) in Belgium: “Guide for the reprocessing of surgical masks and filter mask respirators (FFP2, FFP3) during Coronavirus disease (COVID- 19) Public health emergency “.

For the moment, 3 validation cycles have been carried out and the results given by the chemical and biological indicators meet the requirements. Keep in mind that the relevance of this solution is reinforced by other similar tests, already approved by the US FDA authorities. All this seems to confirm the effectiveness of disinfection with H2O2 and the expectations of the maintenance of the mask performance after 30 decontamination cycles.

Currently, the validation of a series of 10 consecutive cycles is being carried out. The masks thus treated will be sent to an accredited European laboratory to demonstrate that they retain their performance.

Escrito por JORDI NET

Licenciado en Bioquímica por la Universitat Autònoma de Barcelona (UAB) y Máster en Administración de Empresas (MBA) por ESADE.

Experto en tecnologías de esterilización por vapor o calor húmedo, por óxido de etileno y descontaminación con peróxido de hidrógeno vaporizado (VH2O2).