Manufacturing oral solid dosages involves several key powder handling steps, including blending, transfer, storage, and feeding. Successful process-scale up is critical for a batch or continuous manufacturing process. This presentation will cover key powder characterization test methods, including those used to assess flow and segregation behavior, as well as how these methods can be used in successful process scale-up based on first principle and other models. In addition, we will cover trouble-shooting methodologies to address the following common powder handling challanges when scaling-up a process:
- Providing reliable flow and transfer of material between process steps;
- Attaining the required feed and production rates;
- Obtaining within-specification blend uniformity (BU concerns) and content uniformity.
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