This article discusses AITEX’s experience during the turbulent key months of the pandemic. The entire AITEX team worked tirelessly, 24/7, to focus its efforts and energy to the service of the Spanish textile industry, public administration and society.
The laboratories division
Since the beginning of March, more specifically since the Spanish government declared a state of alarm on 14 March, the recent months have been the most intense and stressful that the Institute’s staff have ever experienced. The microbiology laboratory, the medical textiles management unit, the APPE laboratory (non-textile personal protective equipment) and PPE (personal protective equipment: clothing and gloves) have all been working flat out.
We were declared essential and worked 24/7, in microbiology and medical textiles during March, April, May and June, and since the beginning of June in the case of APPE. All of our technical units were bolstered by staff from other units within AITEX, to offer the sector permanent telephone service teams of more than 15 technicians and heads of the laboratories and management units, from six in the morning until half past nine in the evening.
The microbiology laboratory has been testing and approving surgical masks in accordance with standard EN 14683:2019+AC:2019, hygienic single-use masks in accordance with standard UNE 0064 (parts 1 and 2) and hygienic reusable masks in accordance with standard UNE 0065. These three mask types were the workhorse throughout the pandemic. Surgical gowns have also been tested and approved in accordance with standard 13795-1:2019, and the antibacterial capacity of fabrics evaluated in accordance with standard ISO 20743.
All of these efforts enabled Spanish fabrics to be approved for use in surgical and hygiene masks when, at the height of the pandemic in Spain, there was no alternative to fabrics for the manufacture of masks approved by AITEX. The same was true of fabrics for surgical and medical gowns and ready-made masks and gowns.
On 23 March, AITEX had already designed and produced a 5-layer Type IIR surgical mask using non-woven fabric manufactured in Spain with spunlace and spunbond fabrics, and just a month later, a 4-layer reusable hygienic mask based using non-woven fabric. Both prototypes were immediately made available to the Generalitat Valenciana and the Ministry of Industry.
The Generalitat Valenciana, through its IVACE programme, worked impeccably and swiftly set up mask manufacturing capacity, first in five companies in the Valencia Region, and then in a further eight companies. IVACE also promoted the manufacture of sanitary gowns approved by AITEX in another four companies in the Region.
The Ministry of Industry did the same through Fedecon, setting up eight Spanish companies to manufacture the type IIR surgical mask designed and approved by AITEX.
AITEX was not only essential but the only option available for the homologation and manufacture of masks and surgical gowns. We felt the full might of the system (regional administrations, the Spanish administration and all the companies in the sector) flow through us, as the famous meltblown surgical masks manufactured in China could not reach Spain due to China’s enormous demand and that of the wider world. We have certainly lived through exciting times, when the whole team has come together with all the energy it could muster for the greater good.
In addition, we have actively participated in the creation of the UNE 0064 and 0065 standards promoted by the Ministries of Industry and Health at the height of the pandemic. All the testing to define the standards was carried out in AITEX’s microbiology laboratory, (in the case of UNE 0064, throughout the entire Easter holidays). Over the last few months, the laboratory has issued more than 3,000 reports on the results of tests on masks and gowns.
Subsequently, AITEX actively participated in the creation of the CEN WORKSHOP AGREEMENT – CWA 17553, which established the characteristics agreed upon by European countries for disposable and reusable hygienic masks, with more permissive bacterial filtration efficiency (BFE) and respiratory efficiency values than in Spanish standards.
AITEX’s APPE laboratory tests and certifies FFP2 masks according to standard EN 149:2001+A1:2010 and certification for protection only against COVID-19, according to PPE-R/02.075 Versions 1 and 2 (procedures agreed by the VG2 of European notification bodies, with respect to the Essential Health and Safety Requirements marked by Regulation (EU)2016/425). We also approve face and eye protectors, according to Standard EN 166:2002 and our own procedure 25DAT116 and PPE-R/03.031, (procedures agreed by the VG3 of European notified bodies) for the certification of these products for protection against liquid droplets and splashes.
This laboratory has also received a large number of requests for FFP2, the vast majority of which have been imported from China, either by public administrations or by companies for marketing in Spain. The disadvantage was that, during the height of the pandemic, we carried out all the tests for FFP2 at AITEX, with the exception of resistance to sodium chloride filtration, which we had to subcontract to the INSST laboratory in Seville, which is part of the Ministry of Labour. However, our swift response was to purchase the necessary equipment, and put it into operation in May, not without a great deal of effort. Our QA Department worked tirelessly to obtain ENAC approval for the test. Similarly, the PPE department at AITEX is currently testing and certifying clothing and gloves for chemical and biological protection, and exclusively for COVID-19 protection.
The Institute has invested around 200,000 euros in laboratory equipment for testing masks and gowns during the pandemic.
All the AITEX personnel involved have been working flat out, setting a magnificent example of attitude, character, commitment, spirit of service and resilience in the service of the country, business and public administration.
The work of AITEX’s R&D division to provide the country with effective solutions to COVID-19 must also be highlighted, although they were not working under the same degree of pressure as the laboratories. One of the main lines of R&D work in this area is described below.
The successful outcome of the TRUST project by the CDTI (Centre for the Development of Industrial Technology) within the framework of R&D and investment projects to deal with the health emergency declared by COVID-19 cannot be forgotten. This work was awarded the highest evaluation score (90.5) from more than 700 national applications for R&D and investment projects, of which only 25 will be supported by the CDTI. This project is classified within the hygiene and disinfection solutions, competing with others in the pharmaceutical and health fields in the search for a vaccine, detection tests, equipment and therapies for the disease.
A reliable, reproducible and scalable bio-indicator system for the evaluation of massive use disinfection technologies against SARS-CoV-2 and its behaviour in textile structures.
The core goal of the project is to develop a system for the evaluation and validation of different disinfection procedures and technologies against SARS-CoV-2, based on the design and development of a bio-indicator that simulates the size and morphology of the coronavirus. The project will create valuable basic knowledge on the behaviour of the virus in different areas, as well as define, validate, and develop effective procedures and technologies for the prevention of contagion. With a view to the simulation, AITEX is planning to research and develop different series of bio-indicators to rapidly determine the effectiveness of disinfection technologies such as steam, heat by radiation or contact, ozone and UV radiation, without the need to resort to analysis with the viruses themselves and applicable to all types of textile and related surfaces. In parallel, the project will develop functionalised textiles with anti-viral active ingredients effective against the coronavirus.
General Manager AITEX