Particles, whether visible or sub-visible, in a drug product 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 the container/delivery systems (protein aggregates). This section presents papers on particle measurement, management and resultant effects.
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This chapter offers general information and recommendations related to use of glass for pharmaceutical primary packaging.
An overview of NovaPure® particulate testing, including history and validation of LM/IA system.
To investigate aggregation/adsorption of proteins during storage and/or shipment of samples in Daikyo Crystal Zenith® silicone oil free vs siliconized glass PFS.
NovaPure® specs are established based on QTPP's and CQAs, plus their impact on the end patient, the drug product and the pharmaceutical manufacturer.
Uses Differential Interference Contrast microscopy/Extended Depth of Field imaging to nondestructively look at the inside surface of glass containers.
A method used during a manufacturing supply chain for vial stoppers and syringe plungers to improve quality and decrease the particle contamination risks.
Presentation on understanding particles and elastomeric closures, including a case study on the importance of sample preparation.
<p>This detailed article considers the methods and instrumentation needed to accurately detect and characterize particles.</p> <p><em>Malvern Instruments Ltd.</em></p> <p>Access requires (free) registration.</p>
<p>This review article considers in detail the risks caused by the presence of visible and sub-visible particles in parenteral drug products.</p> <p><em>S. Bukofzer, et al. PDA Journal of Pharmaceutical Science and Technology, 69, 123-139 (2015)</em></p> <p> </p>
This article is a brief overview of different types of methods to measure particle size/shape. <p><em>A. DePalma (June 2013)</em></p>
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. <p><em>S.E. Langille. PDA Journal of Pharmaceutical Science and Technology, 67, 186-200 (2013)</em></p>
This presentation reviews methods for detecting particles of varying sizes and how those particles are viewed by regulatory agencies worldwide. <p><em>J.G. Shabushnig (Insight Pharma Consulting, LLC) (June 2014)</em></p>
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