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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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 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.
<span>This presentation discusses risks caused by particles in parenteral drug products </span>
The measurement and control of sub-visible (SVP) particles in injectable drug products is a growing concern in the pharmaceutical industry because of the potential to cause patient harm. The USP has specifications in final drug product for particles >100 um (USP <790>) and > 10 um (USP <788>, USP <787>), but current methods are capable of measuring below 10 µm and into the submicron range. It is well-known that packaging components can contribute to the drug product particle profile but there is limited understanding of contributions from packaging in the range of 0.1–100 µm, in part due to the variability of SVP in biologic products and the difficulty in reliable measurement, identification, and correlation of SVP from packaging components in the final drug product. In order to better understand SVP contribution, particularly from silicone-treated stoppers, a study was designed to determine optimal methods to measure and identify SVP. Stoppers of varying silicone levels were examined. The sample preparation technique was optimized and nine different particle technologies were explored that encompassed a range of 50nm -100um. This presentation will describe the sample preparation considerations for components and analytical technologies for SVP. Data sets will be compared to demonstrate the strengths and weaknesses of various methods.
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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