Design and manufacturing of pharmaceutical containers in high barrier bio-derived Poly (Lactic Acid) PLA

The scope of the project is to develop an innovative biodegradable and suitable for food contact single-dose mono-phase and bi-phase shaker for drugs with high protection against oxygen and water vapor. A biodegradable composite material of the Poly lactic acid (PLA) and micro-lamellar talc dispersed in it that features the utmost barrier properties against oxygen and moisture will be involved in the manufacture of the innovative pharmaceutical container. Additional scopes of the project are: (i) the definition of a simplified and fully automatized production process for the containers manufacturing; (ii) high versatility of the different parts of the containers in the assembly process; (iii) creation of valid alternative end-of-life options for containers disposal to dumping. Project Structure: the project will demonstrate the feasibility of the industrial up scaling of the pharmaceutical containers, especially single dose mono-phase and bi-phase shakers, using an innovative custom-built composite material relying on Poly (Lactic Acid) PLA and entirely compostable. The new products will be launched on the huge market of the pharmaceutical containers by the project proposer (BORMIOLI ROCCO) that can already boast a large network of customers worldwide. The project will address both technical and logistic issues to get to pharmaceutical containers demonstrated at pre-industrial scale. The project will be, essentially, organized in three different phases: Phase 1: Scale up of the innovative material for the fabrication of the new pharmaceutical containers. The formulation of the PLA-based material will be tailored for the specific needs of the pharmaceutical containers, specifically the single-dose shakers. The constituents inside the material will be fine-tuned to achieve a custom-built PLA, which respects the strictest requirements imposed by the drugs market. Lastly, all the necessary steps to bring the formulation to pre-industrial scale by reactive extrusion will be accounted for. In addition, the most suitable manufacturing technologies for the production of the containers, specifically the injection molding process, will be calibrated to transform the innovative PLA-based material at pre-industrial scale and produce the prototypal pharmaceutical containers. Iterative trials and continuous material-process optimization routine will be carried out. Phase 2: Demonstration of the innovative material and the related manufacturing process route. Pharmaceutical containers relying on the innovative PLA grade will be prototyped by pre-industrial scale injection molding process. The prototypal containers, entirely made of the innovative PLA grade, will be showed to the customers and practitioners to demonstrate the capability of a compostable material in the manufacturing of plastic containers with high performance (equal or superior to containers made of conventional plastics). Environmental (i.e., Life Cycle Analysis (LCA)) and Socio-Economic (i.e., Sustainability Indicators (SI)) impact assessments will be implemented to understand the real effect of this innovation in the market of high-tech packaging solutions. Phase 3: Dissemination. The results of the project will be published on the project website that will be appositely created and on technical and scientific journals. The results will be also presented in pertinent events such as fairs, workshops, international conferences. The prototypes of the innovative containers and the relative production technologies will be shown to the stakeholders, policy makers and customers worldwide. The European Industry Association of Plastic Producers, European Bioplastics, will be involved in the dissemination and communication effort of the project results to broader audience. Short list of the Actions. A1. Design of the pharmaceutical containers for pre-industrial scale trials. B1. Fine Tuning of innovative Poly (Lactic Acid) PLA grade for the production of the pharmaceutical containers. B2. Manufacturing of the innovative Poly (Lactic Acid) PLA grade at preindustrial scale. B3. Manufacturing of the pharmaceutical containers at preindustrial scale. B4. Process-Product Optimization and final testing of the prototypal containers. C1. Life Cycle Analysis (LCA). C2. Evaluation of Sustainability Indicators. D1. Dissemination. E1. Project Management. E2. Project Monitoring.