Poster: Relationship Powder Flow and Dosing Machine

Filling machines have complex geometry through which powder has to flow and a significant requirement for filling processes when manufacturing pharmaceutical solid doses is to ensure weight uniformity. The characteristics of powdered formulations considerably affect their behaviour in filling processes and hence affect the ability to generate consistent filling masses.

Recent regulatory initiatives emphasise a greater understanding of the process control space and thus how input variables, such as powder flow characteristics, influence process performance. The results in this study have shown that the powder flow characteristics have to be compatible with the conditions imposed in the process and equipment geometry in order to achieve the target weight uniformity.

Four powdered pharmaceutical excipients were selected for use as test materials in this study. These samples were processed in two pocket dosing Configurations using a Powder Dosing Technologies machine (ITCM). The volumes of the pockets were similar (»410 mm3), but the geometries of the feed hoppers and the pocket shapes were significantly different. The process performance was described by the process capability index, Cpk [2], derived from the weight variance (higher Cpk values indicate better weight uniformity).