Feasibility study on the impact of mechanical recycling on the extractables profile and toxicologic safety assessment of small-scale polycarbonate bioreactors

The use of recycled plastics in the pharmaceutical industry raises safety questions, especially with regards to leaching substances that could compromise patient safety. This feasibility study evaluates the impact of mechanical recycling on the profile of extractables and the toxicological safety of small-scale polycarbonate bioreactors, using post-industrial polycarbonate as a model. Both new and recycled polycarbonate granules and bioreactor vessels were analyzed for extractable substances using chromatographic methods. Key results include the identification of polycarbonate degradation products, which showed a slight increase in concentration after recycling. The study also found adhesive residues from bioreactor manufacturing and degradation products, with no significant accumulation of potentially harmful substances found during recycling. Model safety assessments, including patient exposure calculations and cellular toxicity assessments, showed that recycled polycarbonate poses minimal toxicological risk under worst-case scenarios. The findings support the possibility of recycling polycarbonate for pharmaceutical applications and highlight the need for strict guidelines to ensure patient safety while promoting sustainable practices.