SABYDOMA addresses developments in the safety by design (SbD) paradigm by examining four industrial case studies in detail where the Technology Readiness Levels (TRLs) will advance from 4 to 6.
Each TRL activity progresses from being lab based at TRL4 to being industry based at TRL6. The TRL4 activity involves only innovation with regular industrial communication whereas the TRL6 activity involves industrially located activities with innovation communication.
One of the novel themes of this study is to use system control and optimisation theory including the Model Predictive Control (MPC) philosophy to bind the whole subject of SbD from laboratory innovation to the 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. The screening signal controls the NM redesign and production in a feedback loop.
1. physiochemical sensing elements
2. in vitro targets of increasing complexity from the 2D biomembrane to cell-line and more complex cell-line elements
3. multiple in vitro targets with multiple end-points developed in current H2020 projects
Two of the industrial studies include composite coating manufacture where the coating’s stability and toxicity are tested using a flow through microfluidic flow cell system coupled to online screens. This is part of the release and ageing investigations on the NM and NM coatings and the results of these feed back to the production line design. At every step on the TRL ladder the in silico modelling is applied to optimise and redefine the relevant activities. By the same token regulatory and governance principles of SbD is used to refine the technological development.
The final deliverable will be four distinct technologies applying SbD to the four industrial processes respectively. SABYDOMA’s main aim is to provide a control system solution to Safety by Design. SbD is an evidence based decision (EBD) and is underwritten by control system technology. The solution that SABYDOMA provides is technological and involves screening at the point of production (SPOP) and feeds back the screening results to modify the design, directly coupling therefore screening to design.
SABYDOMA’s technology is represented at the highest level by the Lead Demonstrator shown in the below figure. In this, a line is drawn from the manufactured nanomaterial output and fed into a biomembrane and cell-line screening system. The signal relating to the biological activity of the nanomaterial is used to moderate nanomaterial manufacture. In addition, physicochemical screens are translated to nanomaterial biological activity indicators through QSAR models and the MPC controller to further moderate the nanomaterial production-line.
The following graphics show the production line as blue and the feedback signal as red.
The key to Safety-by-Design (SbD) is directly coupling screening to production
The SABYDOMA concept: Application of systems control to SbD in nanomaterials
A specific example of this approach applied to controlling the biomembrane activity of nanomaterial dispersions is also shown below.
SABYDOMA combines HISENTS biomembrane sensing technology with flow through NM production
The SABYDOMA technology is also used in release studies. In this case, the leachate from an innovative modified corrosion cell for testing coatings, the mini-release accelerator, are screened and the screen signal is used to modify the coating manufacture (see figure below).