With high potency active pharmaceutical ingredients (HPAPIs) comes a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.
A key focus of this paper is the relevant measurement of surface area, with experimental data demonstrating the performance and value of novel instrumentation for in-situ characterization.
Sticking or picking issues are often not detected until transferring the product from research and development to production. Prevent unanticipated problems during scale up and full-scale production by considering tablet compression issues before tablet designs are finalized.
With proper formulation development and tablet design the tablet press operator should be able to manufacture quality tablets without exceeding the tooling’s maximum compression force rating.
A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.
A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving Highly Potent Active Pharmaceutical Ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. read how Flow Sciences used a recently developed containment device and augmented to fit the specific needs of the client.
This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.