This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees
Unconfined yield strength (bulk strength) is the major principle stress that will cause material in an unconfined state to fail in shear. It is the primary flow property that governs the development of hang-ups in process equipment. It is used to compute critical arching and rathole dimensions for a given material in a hopper or bin.
As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.
A significant share of current drug development pipelines include active pharmaceutical ingredients (APIs) that fall into BCS (biopharmaceutical classification system) 2 and 4 spaces. These compounds are typically characterized by their lowaqueous solubility and thus poor bioavailability, requiring advanced formulation approaches. Various approaches have been developed to enable these types of compounds, including particle size reduction (eg, micronization), chemical modification (eg, salt forms and pro-drugs), complexing agents, solubilized liquid forms (eg, SEDDS), and solid amorphous dispersions.
Tip speed (angular velocity) is a constant that can be used to establish an initial blending speed for a given bin geometry. The blender speed may need to be adjusted upon further testing but is a good starting point. The tip radius is the distance perpendicular to the blender rotational center measured to the furthest top bin corner.
Aseptic processing in pharmaceuticals is not without its complications, particularly as they relate to reducing patient risk. This white paper discusses an easy-to-use aseptic processing method that is based on real-world risk factors instead of theoretical concepts while emphasizing the impact of a pharmaceutical manufacturer’s personnel.