Periodic Reporting for period 2 - CleanAir (Lab to Fab development of air decontamination system for protecting health practitioners against COVID19)
Reporting period: 2021-11-01 to 2023-01-31
The COVID-19 pandemic has shown that air disinfection plays a major role in reducing the infection risk in enclosed spaces. Since the majority of infections are caused by transmission via pathogen-carrying aerosols, the development of new, more efficient approaches to remove microorganisms from indoor air is of great importance. The overall objective of project CleanAir was the lab-to-fab development of a new air disinfection technology, as well as the development of a device, which incorporates this technological novelty and serves as a protective measure against Covid-19 and other infectious diseases in medical facilities.
In order to achieve this goal, the following objectives have been defined for the project and worked on by the consortium:
- Development of principal outline and first designs of CleanAir system for the efficient removal of virus-carrying aerosol particles;
- Prototype and first series manufacturing;
- Perform system safety and effectiveness testing;
- Perform testing of the CleanAir device for virus aerosol removal from indoor air quickly, effectively and completely. In addition, the viruses shall be inactivated on the collector plates;
- Design the specific layout and designs of the air decontamination devices for the use in 3 different medical applications (medical doctors’ offices, including waiting rooms, patients’ rooms in the hospital, dental practices);
- Achieve all conformity assessments and audits (CE and FDA) required for market entry;
- Prepare the marketing materials for the innovative CleanAir devices
- Perform the required presale activities
- Pilot installations at selected customer sites for user preference testing
- Improve and finalize the business and sales plan
- Promote the project innovation and the CleanAir devices at conferences, events, trade fairs and through publications
- Achieve market readiness stage of the CleanAir devices within 27 months
Despite several unforeseen challenges, including a partner change in a relatively early stage of the project, it can be concluded that the majority of the planned objectives could be fulfilled within 27 months.
In order to achieve this goal, the following objectives have been defined for the project and worked on by the consortium:
- Development of principal outline and first designs of CleanAir system for the efficient removal of virus-carrying aerosol particles;
- Prototype and first series manufacturing;
- Perform system safety and effectiveness testing;
- Perform testing of the CleanAir device for virus aerosol removal from indoor air quickly, effectively and completely. In addition, the viruses shall be inactivated on the collector plates;
- Design the specific layout and designs of the air decontamination devices for the use in 3 different medical applications (medical doctors’ offices, including waiting rooms, patients’ rooms in the hospital, dental practices);
- Achieve all conformity assessments and audits (CE and FDA) required for market entry;
- Prepare the marketing materials for the innovative CleanAir devices
- Perform the required presale activities
- Pilot installations at selected customer sites for user preference testing
- Improve and finalize the business and sales plan
- Promote the project innovation and the CleanAir devices at conferences, events, trade fairs and through publications
- Achieve market readiness stage of the CleanAir devices within 27 months
Despite several unforeseen challenges, including a partner change in a relatively early stage of the project, it can be concluded that the majority of the planned objectives could be fulfilled within 27 months.
Project CleanAir was performed by 7 highly competent partners in the timeframe from 01.11.2020 to 31.01.2023 and has led to 2 technological novelties, which both can now be launched within the European medical domain for setting new hygiene-, and safety standards within medical facilities and other public spaces:
- LEA™ (Laminar Electrode Array™) air disinfection technology
- PIA™ ASC-CC 9500B air disinfection device (featuring the LEA™ technology)
The functional principle of LEA™ is based on the inactivation of airborne pathogens by exposure to a strong high-voltage electric field. One of the key benefits of this methodology is due to the special material selection for the used microelectrodes, the emission of hazardous by-products such as ozone or NOx is prevented. Yet, a high degree of effectiveness against pathogenic organisms can be provided. LEA™ and PIA™ are the result of extensive research and development activities, which were performed under the framework of the CleanAir project.
The project was initiated by first defining the main system layout and possible installation methodologies for the planned PIA™ air disinfection device.
After thorough market research and definition of expected customer requirements, a ceiling-mounted configuration has been selected. Next, the legal-, and functional requirements for the development, manufacture, and sales of the device have been evaluated and gathered. In parallel, research on the LEA™ air disinfection technology was performed where a number of open parameters critical for system functionality had to be investigated and determined. Furthermore, general efficacy of the technology for removal and inactivation of airborne pathogens had to be tested.
As a first step, laboratory tests using airborne MS2 bacteriophage as a surrogate for SARS-CoV-2 were executed. This testing campaign showed very promising first results about the general efficacy of the technology. Furthermore, it could be proven, that the LEA™ technology is also capable of inactivating Vesicular Stomatitis Virus (VSV), which is a recognized surrogate for SARS-CoV-2 as well. Additionally, the half-life of the real SARS-CoV-2 virus on the technology’s collector electrode was found to be very short with most of the virus being inactivated within 90 seconds. Additional laboratory tests using a gram-positive bacterium, a gram-negative bacterium, and mold spores were conducted afterwards. It could be proven, that besides viruses, LEA™ is also effective against bacteria and mold spores, enabling further application possibilities and use cases.
Additionally, the performance of LEA™ has been evaluated via field tests in the medical environment, where reduction of airborne pathogens during the operation could be observed.
With the gathered results, the consortium was committed to further develop the PIA™ ASC-CC 9500B device to market readiness stage. PIA™ has been conceived for continuous operation and constant treatment of the indoor air, covering a large area within the designated indoor space. As natural indoor air circulation involves ascending of air, the ceiling-mounted device can reach a higher percentage of contaminated air than a floor-standing unit would. Furthermore, PIA™ does not take up valuable floor space, making it an ideal solution for most medical indoor spaces. Another advantage of PIA™ is its low noise emission of max. 32,4 dBA, which enables installation of the device even in patient rooms, where the maximum continuous noise emission by electrical devices must not exceed 35 dBA.
The PIA™ ASC-CC 9500B device is therefore intended to be used as an easily installable unit for reducing the risk of exposure to harmful bioaerosols within medical facilities. Villinger GmbH as the manufacturer will coordinate the marketing and sales of PIA™ and has adapted its manufacturing capacities as well as the internal quality management system to allow production of the device in the required quantities.
Besides numerous application fields in the medical market, the consortium has defined additional installation areas for the PIA™ device as well as possible concepts for future systems based on the LEA™ technology. These include solutions for public buildings, educational institutions, public elevators, public transport, commercial aircraft cabins and manned space stations. Furthermore, a focus of the foreseen exploitation activities will be the offer of the LEA™ technology to OEMs of air purification-, or air disinfection devices via ingredient branding. Manufacturers will be able to acquire a license for the LEA™ technology and upgrade their products with the technology.
- LEA™ (Laminar Electrode Array™) air disinfection technology
- PIA™ ASC-CC 9500B air disinfection device (featuring the LEA™ technology)
The functional principle of LEA™ is based on the inactivation of airborne pathogens by exposure to a strong high-voltage electric field. One of the key benefits of this methodology is due to the special material selection for the used microelectrodes, the emission of hazardous by-products such as ozone or NOx is prevented. Yet, a high degree of effectiveness against pathogenic organisms can be provided. LEA™ and PIA™ are the result of extensive research and development activities, which were performed under the framework of the CleanAir project.
The project was initiated by first defining the main system layout and possible installation methodologies for the planned PIA™ air disinfection device.
After thorough market research and definition of expected customer requirements, a ceiling-mounted configuration has been selected. Next, the legal-, and functional requirements for the development, manufacture, and sales of the device have been evaluated and gathered. In parallel, research on the LEA™ air disinfection technology was performed where a number of open parameters critical for system functionality had to be investigated and determined. Furthermore, general efficacy of the technology for removal and inactivation of airborne pathogens had to be tested.
As a first step, laboratory tests using airborne MS2 bacteriophage as a surrogate for SARS-CoV-2 were executed. This testing campaign showed very promising first results about the general efficacy of the technology. Furthermore, it could be proven, that the LEA™ technology is also capable of inactivating Vesicular Stomatitis Virus (VSV), which is a recognized surrogate for SARS-CoV-2 as well. Additionally, the half-life of the real SARS-CoV-2 virus on the technology’s collector electrode was found to be very short with most of the virus being inactivated within 90 seconds. Additional laboratory tests using a gram-positive bacterium, a gram-negative bacterium, and mold spores were conducted afterwards. It could be proven, that besides viruses, LEA™ is also effective against bacteria and mold spores, enabling further application possibilities and use cases.
Additionally, the performance of LEA™ has been evaluated via field tests in the medical environment, where reduction of airborne pathogens during the operation could be observed.
With the gathered results, the consortium was committed to further develop the PIA™ ASC-CC 9500B device to market readiness stage. PIA™ has been conceived for continuous operation and constant treatment of the indoor air, covering a large area within the designated indoor space. As natural indoor air circulation involves ascending of air, the ceiling-mounted device can reach a higher percentage of contaminated air than a floor-standing unit would. Furthermore, PIA™ does not take up valuable floor space, making it an ideal solution for most medical indoor spaces. Another advantage of PIA™ is its low noise emission of max. 32,4 dBA, which enables installation of the device even in patient rooms, where the maximum continuous noise emission by electrical devices must not exceed 35 dBA.
The PIA™ ASC-CC 9500B device is therefore intended to be used as an easily installable unit for reducing the risk of exposure to harmful bioaerosols within medical facilities. Villinger GmbH as the manufacturer will coordinate the marketing and sales of PIA™ and has adapted its manufacturing capacities as well as the internal quality management system to allow production of the device in the required quantities.
Besides numerous application fields in the medical market, the consortium has defined additional installation areas for the PIA™ device as well as possible concepts for future systems based on the LEA™ technology. These include solutions for public buildings, educational institutions, public elevators, public transport, commercial aircraft cabins and manned space stations. Furthermore, a focus of the foreseen exploitation activities will be the offer of the LEA™ technology to OEMs of air purification-, or air disinfection devices via ingredient branding. Manufacturers will be able to acquire a license for the LEA™ technology and upgrade their products with the technology.
After the successful implementation of the CleanAir project for medical applications, the strategic R&D and manufacturing activities could be extended to further applications in future. Generally, the results of project CleanAir will help to increase Europe’s competitiveness in the global medical market and will contribute to diminishing the danger of future epidemics or pandemics. The consortium is excited to investigate new business opportunities with LEA™ and PIA™, with the aim of creating a safer environment in enclosed spaces of all various sorts and help to secure the wellbeing of the population.