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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.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
Final packaging is often the last process step before a product leaves a factory. Any failure in the process at this point puts the cost of the finished and filled drug at risk, as well as the capacity of the process.<br />
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
As members of the pharmaceutical community, we’re often keenly aware of regional regulatory differences. But it’s just as useful to focus on points of harmony, whether these are well-established, emerging, or implicit in regulatory and industry feedback.
<p><em>Teams Place 15 and 28 out of 120 Teams</em></p><p>The West DragonPhyre and DragonPhlame teams placed 15<sup>th</sup> and 28<sup>th</sup>, respectively, out of the 120 teams competing at the 11<sup>th</sup> Annual Philadelphia Dragonboat Festival on October 6, 2012.</p>
For the second consecutive year since its inception, a total of 91 West employees rose to the challenge and participated in the actimonda Business Run on May 15 in Aachen, Germany.