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Compendium about Scale-Up for the common batch processes of Pharma-OSD

BACKGROUND

On the one hand, increasing international competition is forcing companies to optimize their manufacturing and R&D processes. These trends increase the demand on improved quality and efficiency especially for the processing of consistently shaped and “performing” solids (granules, pellets, etc.). On the other hand, it is absolutely necessary to know and understand the processing dynamics of powders, granules, pellets and to find the most effective processing solutions which can deliver consistent product properties. There are few options to obtain a perfect mix of theoretical and practical training. We bridge this gap between business and education with our decades of experience in the manufacturing and by the use of production equipment. What makes our specialized training so special is

THE UNIQUE HANDS-ON APPROACH.

Industrial pharmacists and pharmaceutical engineers have explored stating norms for scaling up, resulting in scaling up both, process engineering and equipment design. But how well do they work for the development and manufacturing pharmacists, especially those involved in the technology transfer? A linear process has been the general industry norm. But with an increase in complexity of the manufacturing operations and advanced engineering, the scale-up approach has witnessed a change towards becoming more well-organized. On the one hand, increasing international competition is forcing companies to optimize their manufacturing and R&D processes. These trends increase the demand on improved quality and efficiency especially for the processing of consistently shaped and “performing” solids (granules, pellets, powders, etc.). On the other hand, it is absolutely necessary to know and understand the processing dynamics of powders, granules, pellets and the like, and to find the most effective processing solutions which can deliver consistent product properties. Scale-up of manufacturing equipment is often identical in the design from pilot to commercial scale. Only the capacity and/or volume increases. However, some ergonomic changes are unavoidable many times. Although these changes may not create problems each time during a scale-up, one need to be aware of the required adaptions required for pharmaceutical manufacturing – that can become a challenge! It is essential to understand their impact while scaling up on the final product behavior or outcome! Thus, scaling up in pharmaceutical manufacturing is an interesting, yet challenging task!