Safe-by-design strategies applied to scaffold hybrid manufacturing

Abstract

The EU-project FAST (GA 685825) has developed a 3D printer machine prototype for the manufacture of bone implants (scaffolds), by merging masterbatches of biodegradable polymer poly(ethylene oxide)terephthalate/poly(butylene terephthalate) [PEOT/PBT] doped with nanofillers [reduced graphene oxide (rGO), hydroxyapatite (HA) and magnesium aluminium hydroxide ciprofloxacin hydrotalcite (LDH-CFX)], and atmospheric plasma technology. This paper focus on the safe design strategies identified by FAST to address the risk to health resulting from the potential airborne emission of nano-objects and their aggregates and agglomerates (NOAAs) by the 3D printer prototype, which might result in occupational exposures by inhalation. The work also includes measurements of airborne emissions and occupational exposures carried out during the verification stage of the prototype design. Nanofillers particles (rGO, n-HA, LDH-CFX) were not observed, neither at source nor in the working area, suggesting no release of free nanofillers to the air one they have been embedded in the polymer masterbatch. Additionally, the exposure in the workplace was far below the selected Occupational Exposure Levels (OELs), for total particle number concentration (PNC), dust, elemental carbon (EC) and volatile organic compounds (VOCs). The results showed that, when working with the current prototype in normal operation (for its intended use) and with controls enabled [enclosure with the doors closed and Local Exhaust Ventilation (LEV) activated], the emission from the machine and the worker's exposure to NOAAs are well controlled.