Some published articles purport to demonstrate the difficulties and problems of the laser diffraction technique without mentioning that these apparent problems are inherent in all particle-sizing techniques. This article discusses some of the advantages of using laser diffraction for particle sizing-including repeatability, ease of verification, and speed of measurement-and why it has become the preferred technique in a range of industries.
IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.
This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.
The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.