APPLIED TECHNOLOGY 3D PRINTING


HOW 3D PRINTING NASAL SWABS HAS HELPED IN THE FIGHT AGAINST COVID-19


The COVID-19 pandemic has tested global healthcare capabilities, with supply chains being disrupted, requiring local agile solutions for certified medical devices. So, many companies collaborated with their local governments to provide critical medical devices such as ventilator components, ICU critical parts, face shields, face mask filters, etc., to fight the shortages. In March 2021 a collaborative R&D consortium was created to develop


certified medical devices and ramp up mass production in North America and Europe. This consortium included Aenium Engineering and Burloak Technologies, who worked closely with EOS’ Additive Minds applied engineering team, the Canadian and Spanish health authorities and hospitals, as well as a Spanish genomic laboratory (ITALCyL). It soon became clear that with the demand for COVID-19 test kits


combined with the empty inventory of conventionally manufactured nasal swabs, additive manufacturing would be the ideal technology for bridging this gap. There were, however, challenges – the first of which was the sampling itself. It is essential for the test swab to preserve the virus’s integrity to allow RNA detection by means of reverse transcriptase real-time PCR. A solution was needed with a porous-specific activated surface on the head plus a highly flexible stick which cannot be manufactured conventionally. The second challenge was the high demand


for a cost-effective solution. However, Aenium and Burloak developed a model for producing up to 40,000 swabs per day on multiple EOS AM systems. Thirdly, nasal swabs are a class IIa medical


device, requiring a specific certification for testing and qualification to fulfil medical standards. Therefore, a typically long certification procedure with the public administration and laboratories to approve the intended use was required. Aenium started clinical trials with the


Spanish authorities on April 25 2020, and performed hundreds of clinical comparisons with commercial nasal swabs. During the trials, RNA was processed by one-step RNA real-time PCR using two kits RT- PCR (BGI) and ref. RR064A (Takara) to detect SARS-CoV-2. Both nasal


swabs included an endogenous control, obtaining positive results compared with the same clinical trials over other certified conventionally manufactured commercial swabs. Aenium and Burloak developed a RNA-free nasal swab with specific laboratory-tested parameters. The nasal swabs were manufactured on EOSINT


P 385, EOS P 396 and EOSINT P 760 systems using EOS PA2200 material. A full procedure for ensuring the performance, including clinical performance, technical properties and medical device requirements, was achieved for Europe and North America. Rapid Manufacturing Systems


(www.rmsiberia.com) contributed to the mass production vision of offering market value for the nasal swabs’ industrialisation. Based on this success, more products are in the pipeline (e.g. pediatric nasal swabs).


Aenium is working with the Spanish government and hospitals to


produce hundreds of thousands of medical nasal swabs for use in COVID- 19 test kits. ITACyL, a public laboratory, and other Spanish laboratories, have tested


the performance and carried out the clinical validation to successfully achieve AEMPS (Spanish Agency of Medicines and Medical Products) certification for the mass production of this IIa class medical device. Burloak is helping North American hospitals and public health systems


to increase production capabilities and fight against stockouts of this critical medical device. The results and benefits of the project include:


• Clinical tests have demonstrated the performance of the 3D-printed nasal swab, a class IIa medical device, as an effective option compared to the commercial nasal swabs.


• Nasal swabs can be produced anywhere in the world according to a decentralized model thanks to additive manufacturing.


• EOS industrial 3D printing polymer solutions enabled agile production for a fast response due to supply chain gaps with a highly accepted material in the medical sector.


• On-demand manufacturing: No expensive tooling needed, just start the systems and qualify the process. Commenting on this, Jose Miguel Ampudia, chief technical officer and


R&D manager at Aenium Engineering, said: “This is the first 3D-printed nasal swab certified by a government agency and was made possible by collaboration between Aenium, Burloak, Additive Minds and many others. It demonstrated the great opportunity for empowering private-public consortia in the fight against global challenges using industrial 3D printing – an inspiration for others worldwide.”


EOS


Aenium Engineering Technologies


8 MARCH 2021 | DESIGN SOLUTIONS


www.eos.info www.aenium.es


www.burloaktech.com / DESIGNSOLUTIONS


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