Prediktiv modell för att minska kasserat material vid tablettslagning

Sammanfattning

During start-up of tablet presses in pharmaceutical manufacturing, multiple weight adjustments are often required before the tablet weight falls within acceptable limits. This leads to delayed production and a waste of material. The aim of this work was to develop a predictive model to reduce the number of adjustments during start-ups and thereby reduce the amount of rejected material. A linear regression model was developed based on the relationship between changes in punchy separation and resulting changes in tablet weight. The model was evaluated during 61 start-ups, of which 19 were performed with starting weights deliberately manipulated up to 80 mg from the weight limit to test the model’s robustness. A residual analysis was conducted to identify underlying factors affecting the model’s predictive performance. The results showed that the model accurately describes the relationship between punch separation and tablet weight, and that the model coefficients are representative for a larger sampling period. Implementation of the model would reduce the average number of adjustments from 2,7 to 1,05 per start-up, corresponding to a reduction of 61% and saved material equivalent to approximately 1,9 million tablets per year. The residual analysis identified the magnitude of step height change as the dominant factor behind the model’s limitations for starting weights far from the weight limit, while raw material, granulation machine, tablet press, compression force and rotor speed showed marginal or no influence on the model’s performance. It is concluded that the developed model can standardize and streamline the start-up process, reduce operator dependency and significantly reduce material waste. The methodology is transferable to other pharmaceutical products, and future work may focus on improving the model’s performance for starting weights far from the weight limit, as well as developing a corresponding model for hardness adjustment.