Tablets & Capsules

TC1019

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Tablets & Capsules October 2019 25 In continuous manufacturing, the process steps occur one after the other without interruption, so the raw materials are fed into the system and the finished prod- uct is discharged from the system simultaneously. This results in shorter throughput times and eliminates the need for intermediate storage, reducing production costs and plant-size requirements and allowing for greater production flexibility. With continuous manufacturing, production volume is controlled via the production time. Scale-up becomes obsolete, which reduces development costs and time and API usage. Continuous manufacturing processes also offer optimized quality monitoring, which ensures con- sistently high product quality. The value of changing from batch to continuous pro- duction depends on a number of factors, including the active ingredient, the production amounts required, and whether the product has already been approved or is still in development. Pharmaceutical manufacturers should discuss these factors with their equipment suppliers, as the costs and benefits vary on a case-by-case basis. Continuous pharma's current status and challenges Continuous manufacturing is not new to the pharma- ceutical industry. Even in batch production, some of the individual processing steps operate in a continuous man- ner, such as dry granulation using roller compactors or tableting. Other processes, such as dosing, mixing, and trend toward highly potent active ingredients and more personalized drug products will also influence produc- tion and process requirements, leading to smaller and more flexible production quantities with the shortest possible time to market. For many decades, the phar maceutical industr y has manufactured SODFs using traditional batch pro- duction processes. To a great extent, these processes have already been optimized and offer little opportu- nity for significant further efficiency improvements. As a result, large and medium-sized pharmaceutical companies have recently turned their attention to con- tinuous processes, which have long been used in other industries, such as chemical manufacturing. Generic and contract pharmaceutical manufacturers are also increasingly interested in continuous processing. Against this background, a paradigm shift is taking place in the pharmaceutical industr y that will f un- damentally change the inf rastr uct ure and internal processes of SODF manufacturers. From batch to continuous manufacturing In batch production, a set amount of raw material is fed into each process step and the same amount is removed at the end of each process step, resulting in non-value-added charging and discharging operations and requiring additional plant space to store the material between steps. dfepharma.com Learn more about our SuperTab ® anhydrous range SuperTab ® 21AN SuperTab ® 22AN SuperTab ® 24AN improved flow improved compaction A complete range of Anhydrous lactose Offering improved functionality fitting your formulation needs

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