Periodic Reporting for period 3 - SABYDOMA (Safety BY Design Of nanoMaterials - From Lab Manufacture to Governance and Communication: Progressing Up the TRL Ladder)
Berichtszeitraum: 2022-10-01 bis 2024-03-31
SABYDOMA addresses Safety-by-Design (SbD) through 4 industrial case studies, where TRLs advance from TRL4 (lab-based) to TRL 6 (industry-based). A core theme is use of system control and optimisation theory, including Model Predictive Control (MPC), to bind together SbD from laboratory innovation to industrial production line and from decision-making processes to project governance. An equally important innovative step is the building of high throughput online platforms where nanomaterial (NM) is manufactured and screened at the point of production (PoP). In this, the screening signal controls the NM redesign within a feedback loop. 2 industrial case studies are developing online nanoproduction lines coupled to online screens where the screening signals feed back to the production line to modify the NM design. The other 2 industrial studies include coating manufacture where the coating’s stability and toxicity is being tested using a microfluidic flow cell system coupled to online screens. This is part of the release/ageing investigations on NM and NM coatings and the results of these will feed back to the production line design. In-silico modelling will be applied to optimise/redefine the relevant activities. Regulatory and governance principles of SbD will also be used to refine the technology. The final deliverable will be 4 distinct technologies applying SbD to the 4 industrial processes respectively.
SABYDOMA is an innovation programme attacking Safety-by-Design using a novel approach, which is technologically based and involves the following objectives, to:
1. Model SbD protocols using the systems control and optimisation protocol with the MPC concept.
2. Design high throughput platform technologies progressing from TRL4 to 6.
3. Innovate technology to carry out short and long-term release studies on NM and NM derived materials matching the theme of online flow through platforms.
4. Develop SbD technologies within the context of four industrial case studies involving the production, use and function of engineered nanomaterials (NM).
5. Redesign the production lines in the electroplating technology at Cnano to an online high throughput mode to: speed up the production process, minimise volumes used, lower costs and minimise waste.
6. Extend the control system idea of SbD to a general philosophy applied to the manufacture and use of novel NM, chemicals and pharmaceuticals.
SABYDOMA is an innovation programme attacking Safety-by-Design using a novel approach, which is technologically based and involves the following objectives, to:
1. Model SbD protocols using the systems control and optimisation protocol with the MPC concept.
2. Design high throughput platform technologies progressing from TRL4 to 6.
3. Innovate technology to carry out short and long-term release studies on NM and NM derived materials matching the theme of online flow through platforms.
4. Develop SbD technologies within the context of four industrial case studies involving the production, use and function of engineered nanomaterials (NM).
5. Redesign the production lines in the electroplating technology at Cnano to an online high throughput mode to: speed up the production process, minimise volumes used, lower costs and minimise waste.
6. Extend the control system idea of SbD to a general philosophy applied to the manufacture and use of novel NM, chemicals and pharmaceuticals.
WP1 - Has developed 2 online production lines for Ag and TiO2 NM materials. An auxiliary tank has been configured for use in electroplating of nanocomposite coatings. Development of online microfluidic cell-line modules in WP1 has begun which is to be coupled to nanoproduction lines.
WP2 - Has streamlined/duplicated the HISENTS biomembrane sensor, which has been transferred to APPNPS; and Ag NM nanoproduction line to APPNPS. In-vitro models have been developed for assessment of ToxScores, coupled to the biomembrane sensor output; and, the electroplating technology refined by Cnano under WP1 is being scaled-up.
WP3 - Begins in Period 2 of the project.
WP4 - Concerns release studies from NM, covering: (a) releases involved and their minimisation using new technology in the manufacture of the NM and the NM coatings; (b) the mini-release accelerator, has been developed to screen the releases online from NM coatings. The mini-release accelerator is being coupled to the biomembrane sensor as a rapid online toxicity screen and is in the process of being transferred to 2 case study partners.
WP5 - Aims to analyse requirements of the ΝΜ production processes with respect to design, optimisation and implementation of advanced control systems, which enable safe-by-product design (SbPD) and safe-by-process control (SbPC). A preliminary process model has been developed that is used to produce optimal control actions and directions for the experimental design at UNIVLEEDS.
WP6 - This WP is well advanced and is active on the regulation, governance and data management associated with SbD. A highlight is the first SbD legal workshop in which expert speakers spoke about the definition of, and the legal aspects of SbD.
WP7 - Concerns dissemination of SABYDOMA and its achievements, that are well ahead of expectations.
WP2 - Has streamlined/duplicated the HISENTS biomembrane sensor, which has been transferred to APPNPS; and Ag NM nanoproduction line to APPNPS. In-vitro models have been developed for assessment of ToxScores, coupled to the biomembrane sensor output; and, the electroplating technology refined by Cnano under WP1 is being scaled-up.
WP3 - Begins in Period 2 of the project.
WP4 - Concerns release studies from NM, covering: (a) releases involved and their minimisation using new technology in the manufacture of the NM and the NM coatings; (b) the mini-release accelerator, has been developed to screen the releases online from NM coatings. The mini-release accelerator is being coupled to the biomembrane sensor as a rapid online toxicity screen and is in the process of being transferred to 2 case study partners.
WP5 - Aims to analyse requirements of the ΝΜ production processes with respect to design, optimisation and implementation of advanced control systems, which enable safe-by-product design (SbPD) and safe-by-process control (SbPC). A preliminary process model has been developed that is used to produce optimal control actions and directions for the experimental design at UNIVLEEDS.
WP6 - This WP is well advanced and is active on the regulation, governance and data management associated with SbD. A highlight is the first SbD legal workshop in which expert speakers spoke about the definition of, and the legal aspects of SbD.
WP7 - Concerns dissemination of SABYDOMA and its achievements, that are well ahead of expectations.
Progress beyond SOTA and expected results are:
1.Safety-by-Design & Case Studies (CS) developed, validated/demonstrated within 4 separate companies.
2.Systems control optimisation to be introduced for first time in applying SbD to safe NM manufacture.
3.Online flow platforms for manufacturing NM for CSs for production of Ag/CuO in CS1 and TiO2 in CS4, have been built. A platform has been transferred to a CS company and a duplicate platform is due to be transferred to another.
4. SABYDOMA has coupled screens directly to NM production where the screen results moderate NM production for safe NM as output using control system technology.
5.Interfacing ToxScore with NM design combining screening data as a toxicity ranking and feeding this back to NM design.
6.Integrated biological screens for more rapid/relevant bioactivity testing, combining effective and toxicity relevant high throughput targets with flow-through platforms.
7.Release studies investigating 3 distinct release study areas directly associated with individual Case Studies.
8.Online systems embedded in industrial scale electroplating: SABYDOMA has introduced a reflow system into electroplating technology minimising waste & enabling maximum use of resources as well as improving coating quality.
9.A modified Stage-Gate model, incorporating TRL4 to 6 details with specific milestones for regulatory actions, is being devised. Modifications to this model include incorporation of control system optimisation to each decision-making process.
Socio-economic/wider societal impacts include:
1.Development of an integrated platform which manufactures, screens, and re-designs NM online. Implicit in this is the principle of screening at PoP, which means the NM is screened at an early stage in its development, avoiding minimal change in its properties enabling the direct and rapid synthesis of safe-nano at site.
2.The online platform NM production technologies proposed are sealed systems and use the minimal ingredients with minimal manual handling. The coating technologies in 2 case studies will be converted from batch to online and as such alleviate manual handling and exposure and provide a safer working environment.
3.All NM produced/coatings manufactured will be subject to release study investigation. Release studies will be conducted within flow systems & any release of NM or toxicants above a safety threshold will be signalled and results fed back to the production line for redesign. The same protocol will be applied to the coating manufacture in 2 Case Studies. As a result, the NM production has the least damaging impact on the environment above all from NM released during use of the product. The continuous communication with the partner CS companies: APPNPS and NTC, ensures the impact of these technologies will be fully realised having been transferred.
4.Emphasis is on low cost towards developing methods & assays that are safe, fast, cheap, & providing high-quality information. The focus of developing online NM production technology & high throughput screens interfaced to the NM production line uses less staff & fewer materials, is faster & thus saves considerably on costs. This has a major societal and economic benefit.
1.Safety-by-Design & Case Studies (CS) developed, validated/demonstrated within 4 separate companies.
2.Systems control optimisation to be introduced for first time in applying SbD to safe NM manufacture.
3.Online flow platforms for manufacturing NM for CSs for production of Ag/CuO in CS1 and TiO2 in CS4, have been built. A platform has been transferred to a CS company and a duplicate platform is due to be transferred to another.
4. SABYDOMA has coupled screens directly to NM production where the screen results moderate NM production for safe NM as output using control system technology.
5.Interfacing ToxScore with NM design combining screening data as a toxicity ranking and feeding this back to NM design.
6.Integrated biological screens for more rapid/relevant bioactivity testing, combining effective and toxicity relevant high throughput targets with flow-through platforms.
7.Release studies investigating 3 distinct release study areas directly associated with individual Case Studies.
8.Online systems embedded in industrial scale electroplating: SABYDOMA has introduced a reflow system into electroplating technology minimising waste & enabling maximum use of resources as well as improving coating quality.
9.A modified Stage-Gate model, incorporating TRL4 to 6 details with specific milestones for regulatory actions, is being devised. Modifications to this model include incorporation of control system optimisation to each decision-making process.
Socio-economic/wider societal impacts include:
1.Development of an integrated platform which manufactures, screens, and re-designs NM online. Implicit in this is the principle of screening at PoP, which means the NM is screened at an early stage in its development, avoiding minimal change in its properties enabling the direct and rapid synthesis of safe-nano at site.
2.The online platform NM production technologies proposed are sealed systems and use the minimal ingredients with minimal manual handling. The coating technologies in 2 case studies will be converted from batch to online and as such alleviate manual handling and exposure and provide a safer working environment.
3.All NM produced/coatings manufactured will be subject to release study investigation. Release studies will be conducted within flow systems & any release of NM or toxicants above a safety threshold will be signalled and results fed back to the production line for redesign. The same protocol will be applied to the coating manufacture in 2 Case Studies. As a result, the NM production has the least damaging impact on the environment above all from NM released during use of the product. The continuous communication with the partner CS companies: APPNPS and NTC, ensures the impact of these technologies will be fully realised having been transferred.
4.Emphasis is on low cost towards developing methods & assays that are safe, fast, cheap, & providing high-quality information. The focus of developing online NM production technology & high throughput screens interfaced to the NM production line uses less staff & fewer materials, is faster & thus saves considerably on costs. This has a major societal and economic benefit.