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A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
It is important to consider all sources in particle evaluations of drug products. Particles can be classified as:
The occurrence of particles in drug products originating from package components or delivery systems can be a concern depending on the origin and nature of the particle. For example, glass shards or lamellae could cause significant patient harm. The total contribution from the package/delivery components and the drug product itself should be determined during formulation studies to reduce unexpected risks to product quality and patient safety.
Questions that manufacturers should consider regarding their drug products are:
With all these questions, West can help. Particle measurement is a technology focus area in Analytical Lab Services and a key offering of the Integrated Solutions platform. West has experienced staff and state-of-the-art facilities to address customer needs. For more, please contact an Account Manager or Technical Customer Service (TCS) representative.
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, & Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination<sup>1</sup>.
To support customers as they navigate the path from drug product discovery to commercialization, West has undertaken a new, proactive strategy: <em>Integrated Solutions.</em> For almost 100 years, West has been developing technical and regulatory expertise in primary drug packaging, delivery devices, and combination products. That wealth of industry experience is now offered to customers who can employ it for any stage of development (Prescreen and Compatibility, Clinical Phases I / II / III, and Lifecycle Management).
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
United States Pharmacopeia (USP) held a two-day workshop, <em>Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics</em>, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.
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