12. March 2016
The mechanical strength, particle size and sphericity of starting sugar spheres for drug layering and subsequent functional coating applications are critical to achieving a reproducible and high yield final product. During early processing, spheres can be subjected to high mechanical stress that may result in the generation of fines, changes in particle size and loss of sphericity. The European Pharmacopoeia describes both a fluidization apparatus and an oscillating apparatus method for...
30. July 2015
A key challenge of manufacturing is variability. Variability is caused by many operational and human factors including human error, environment, wear and tear, variability in raw materials and active ingredients, and unclear procedures. It could also result from product and process design, for example, due to insufficient raw material controls and poorly defined processes. More