Model-Guided Development of a Semi-Continuous Drying Process.

Introduction: With an increased adoption of continuous manufacturing for pharmaceutical production, the ConsiGma® CTL25 wet granulation and tableting line has reached widespread use. In addition to the continuous granulation step, the semi-continuous six-segmented fluid bed dryer is a key unit in the line. The dryer is expected to have an even distribution of the inlet air between the six drying cells.

Sampling and diversion strategy for twin-screw granulation lines using batch statistical process monitoring.

Continuous manufacturing is now considered as a well-established technique by pharmaceutical companies. However, the limited number of filed applications reflects the complexity to translate a science that has been described in many publications to an actual drug product. Process stability evaluation and resulting sampling and diversion strategy are key aspects of the design of continuous processes which require the development of new approaches.

Managing API raw material variability in a continuous manufacturing line - Prediction of process robustness.

Many studies on continuous twin-screw granulation only focus on the granulator without linking this process step to the upstream and downstream unit operations. Product critical quality attributes (CQAs) are however not only determined by the granulation step. In this study, the possibility to manage the batch-to-batch variability of an active pharmaceutical ingredient (API) in a high drug loaded formulation on a continuous line was investigated to obtain consistent tablet CQAs.

Managing API raw material variability during continuous twin-screw wet granulation.

Very few studies have investigated the impact of raw material variability upon the granule critical quality attributes (CQAs) produced via twin-screw wet granulation (i.e., granule size distribution, density, flowability).

Managing active pharmaceutical ingredient raw material variability during twin-screw blend feeding.

Continuous powder feeding is a critical step in continuous manufacturing of solid dosage forms, as this unit operation should ensure the mass flow consistency at the desired powder feed rate to guarantee the process throughput and final product consistency. In this study, twin-screw feeding of a pharmaceutical formulation (i.e.