Particles in a drug product, whether visible or sub-visible, are a very serious concern (e.g., obstruction of blood vessels, inducement of immunogenicity). Particles may result from external sources (e.g., dust), manufacturing (e.g., silicone oil), or interaction with package/delivery systems (protein aggregates). This section presents papers on particle measurement, management and resultant effects.
Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products.
S. Bukofzer, et al. PDA Journal of Pharmaceutical Science and Technology, 69, 123-139 (2015)
This review article considers in detail the risks caused by the presence of visible and sub-visible particles in parenteral drug products.
Particulate Matter in Injectable Drug Products.
S.E. Langille. PDA Journal of Pharmaceutical Science and Technology, 67, 186-200 (2013)
This article considers several aspects of particles in parenteral drug products: (a) sources, (b) composition/shape/size, (c) differing effects depending upon place/route of administration and condition treated, and (d) regulation.
A Basic Guide to Particle Characterization.
Malvern Instruments Ltd.
This detailed article considers the methods and instrumentation needed to accurately detect and characterize particles.
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Particle Sizing: Many Size Domains, Many Approaches.
A. DePalma (June 2013)
This article is a brief overview of different types of methods to measure particle size/shape.
Visible Particles: Regulatory and Compendial Requirements.
J.G. Shabushnig (Insight Pharma Consulting, LLC) (June 2014)
This presentation reviews methods for detecting particles of varying sizes and how those particles are viewed by regulatory agencies worldwide.