Purpose: A powder for oral use formulation was filled into sachets. The low % of active ingredient (< 4%) with a low fill weight of 1.5 g/sachet, combined with the cohesive and non flowing nature of the blend makes the filling operation critical to ensure appropriate weight control to achieve the correct dosing. The objective of this poster is to explain the filling process, selection of appropriate auger/funnel combination with the critical controls derived using statistical analysis of the in process weight data.

Method:

A sachet filling machine works on the principle of delivering a measured amount of powder using an auger and funnel set up. With no feed back loop to automatically adjust the amount delivered, the selection of the auger and funnel combination is critical to the accuracy of the powder fill weight. Trails with several different size augers namely, 3/8 inch, 1/2 inch, 9/16 inch and 5/8 inch were carried out to select an appropriate auger. In process weight checks were used to monitor the filling operation and this data was statistically analyzed and correlated to potency of the filled sachets.

Results:

The smaller augers 3/8 inch and 1/2 inch gave better accuracy of fill, but resulted in a process that was less stable. The 5/8 inch auger was less accurate and in process weight variations were high. The 9/16 inch auger gave the right combination of accuracy and consistency with a stable filling process.

Conclusion:

Based on statistical analysis of in process data and confirmed by analytical testing for potency, a 9/16 inch auger was selected for filling this powder for oral use formulation into sachets.