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Injection Moulding Repurposing for Medical Supplies enabled by Additive Manufacturing

Periodic Reporting for period 1 - imPURE (Injection Moulding Repurposing for Medical Supplies enabled by Additive Manufacturing)

Reporting period: 2020-12-01 to 2022-05-31

For many years the risk of emerging infectious diseases with pandemic potential was declared a major threat to global health security and addressed by many stakeholders around the world. The delay in imposing risk mitigation measures is crucial and can make the difference between a local outbreak with few cases to a pandemic with countless sick and deceased citizens, as severely demonstrated by the recent outbreak of Coronavirus disease 2019 (COVID-19). It is of paramount importance that appropriate and proportionate measures to each phase of the pandemic are immediately implemented to interrupt human-to-human transmission chains, prevent further spread and reduce the intensity of COVID-19 outbreak. Immediate activation of national emergency response mechanisms and pandemic preparedness plans to ensure containment and mitigation of COVID-19 with non-pharmaceutical public health measures is critical for delaying transmission or decreasing the peak of the outbreak, in order to allow healthcare systems to prepare and cope with an increased influx of patients. However, shortages and other gaps in the global medical supply chain represent a mismatch of supply and demand when supply is low and/or demand is high for particular items. In this sense, imPURE project targeted to: i) exploit and repurpose existing pilot lines for production of medical supplies, ii) design and develop modular moulds for injection moulding, and iii) assure a broad distribution in EU of medical supplies. imPURE managed within 18M to develop an methodology for a fast repurposing of Industrial Injection moulding lines, enabling Additive Manufacturing Technologies, in order to manufacture interchangeable cavity inserts, to be used for the production of Critical Medical Supplies (i.e. masks, oximeters, vaccine spikes and ventilator splitters).
WP1 focused on determining the different CMSs (imPURE demonstrators), including the products' design, the materials used, and crucial operational requirements. A respirator mask, a finger pulse oximeter, a vaccine spike, and a ventilator splitter, were selected to be fabricated. In addition, polymers with antimicrobial properties were prepared, including silver nanoparticles, which were used as raw materials for the production of the CMSs. Toxicological assays were carried out, in a general framework of safety use that was followed. Concerning the metal AM activities, a market overview and a classification of the available metal powders were performed, based on the established in-house metal AM powder characterization workflow, together with specific procedures for refurbishing used AM powders. Finally, a regulatory framework and specific timeplans for the exploitation of the products were defined.
WP2 developed the IM production lines' upgrading/repurposing strategy. Considering the demonstration production line, set of sensors and transducers were installed on the machine for process monitoring and software and hardware for data acquisition and communication. A robot handling system has been designed, programmed, and applied to the PASCOE IM machine, aiming to enhance production automation. An infrared camera was also installed in the line for the quality monitoring of the produced parts. Accordingly, the the industrial line of ELVEZ was upgraded with the installation of pressure and temperature sensors. The rest IM lines (STIL and PROD) were repurposed with inserts manufactured through AM.
WP3 included the designs of the new mould sets. Specifically, for the oximeter case, a repurposed mould was used with integration of AM inserts and ceramic sliders. Regarding the vaccine spike case and the ventilator splitter, old master moulds were refurbished and new AM inserts were introduced; conformal cooling system was applied in the case of the ventilator splitter. Finally, new base moulds were designed for the production of the masks.
WP4 focused on the manufacturing of the interchangeable inserts through AM technologies and hybrid approaches. A methodology for each of the AM processes was developed (SLM, DED, Hybrid approach with WAAM). Concerning the oximeter case, ceramic mould components were produced by SLA 3D printing, assessing the required processability and dimensional accuracy.
In the framework of WP5, IUNGO developed a supply chain interactive platform, for raw materials and CMSs. imPURE Project Communication tools were developed (website, Social Media, Webinars) and a detailed Exploitation Plan was released. In addition, networking/dissemination activities included more than 150 actions: meetings and video calls with companies, universities, districts, and experts, participation in conferences, workshops, exhibitions, etc. A scientific paper was also published from IRES in collaboration with NTUA.
The first main result of WP6 was the Data Management Plan, that defined the information workflow. User experience research was carried out through interviews with different representatives from the pilot lines, resulting in defining the proto-personas, user journey, and user needs statements to design the command centre for the pilot lines. A cloud manufacturing platform was developed for the selected pilot examined, and a proof of concept was performed to interact with the Machine Learning models. Simulation-based digital twins were also prepared.
Within WP7, all managerial procedures were defined, that ensured the smooth execution of the project. A Risk Management and a Quality Assurance Plan were prepared, while all administrative procedures were followed.
Finally, WP8 was focused on the ethical requirements that have been set by the EC. Four deliverables were prepared, dealing with Humans, Environment and Safety, Data Protection and involvement of Non-EU Countries.
Within imPURE, automation technologies and remote monitoring systems were employed for Cloud Manufacturing (CMfg)-based service integration to be demonstrated in plastic processing and injection moulding lines available in the consortium (PASCOE, ELVEZ, STIL, PROD). Optimal configuration methods were applied based on the degree of automation and monitoring of each line, supported by multi-physics simulation models with feedback from sensors in the production workflow. Various data in the entire injection moulding process, including mould design, mould manufacturing and the injection moulding process were linked to achieve more efficient, smart and sustainable manufacturing environment.

Main Results:
- Interchangeable cavity plates for IM produced via Additive Manufacturing Technologies
- Production of four Critical Medical Supplies (face masks, oximeters, vaccine spikes, ventilator splitters)
- Repurposing of IM line of four industries and refurbishing of used moulds, exploiting AM technologies and machining processes

imPURE impact can be summarised in the following:
• Fast repurposing of injection plastic moulding lines with use of interchangeable cavity inserts of targeted medical consumables
• Methodology of numerical modelling, process and mould design optimization for selected medical consumables
• Cloud Manufacturing and Automation technologies for deploying new operating procedures and automation solutions
• Adapted operational planning and supply chain management
• Fast repurposing of industrial production lines, to meet the urgent needs of a pandemic situation
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