Ordinal Logistic Regression Model of Failure Mode and Effects Analysis (FMEA) in Pharmaceutical Tabletting Tools

The main objective of this paper is to use Ordinal Logistic Regression Modeling (OLRM) to predict and to investigate the relationship(s) between the different types of failures encountered in tableting tools of pharmaceutical industry and relevant tablet- and punch attributes. This would help minimize the occurrence of such failures in and avoid potential failure occurrences in future punch designs. Three punch attributes (punch diameter, location and shape) and five product attributes (tablet mass (gm), hardness (Kp), thickness (mm), moisture content (percent loss on drying (LOD %)) and sieve size (mm)) have been investigated in terms of their relative contributions towards different failure types. The present OLRM model has been successfully applied to the predict failure types according to the aforementioned factors. Furthermore, OLRM quantitatively links and evaluates the effects and contribution of each of these factors to the occurrence of different failure types. The OLRM methodology has been validated conveniently and proved to be powerful prediction tool. This is indicated by the marginal 2.4% error percentage encountered.

► FMEA has been applied in pharmaceutical industry through OLR modeling.
► Different failure modes of tabletting punches have been evaluated.
► Main factors controlling failures are punch diameter, location and shape.
► Other controlling factors are product hardness, thickness.
► Edge breakage accounts majority of failures.