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The overall quality of a final drug product depends on the components of its packaging and delivery systems. The use of visually inspected components reduces the risk of defective components and helps ensure patient safety.
Final drug products are 100% visually inspected for particles and defects. The aim of visual inspection is to remove defective units, which reduces risks. Such prevention is also a regulatory expectation. This can be achieved by adopting an inspection life cycle approach that provides a framework for continuous process improvement. This approach involves multiple elements, such as qualification, maintenance, training, and categorization of defects. It also includes testing of components to specific quality attributes, and evaluation processes for component preparation and drug product filling procedures. Adoption of visually-inspected components can be a part of this life cycle approach; it will help to ensure the prevention of both particles and defects appearing in final drug product.
Manufacturing defects in components, and loose or embedded visible particles, can lead to sterility failures and loss of container closure integrity. In prefilled syringes and cartridges, these defects might also affect functionality. The recent paper Mitigating Risk in Pharmaceutical Manufacturing with Visually Inspected Components (p. 52) discusses these issues in detail. One way to significantly minimize the presence of particles and defects is with the West ENVISION™ process. This is an automated vision inspection that occurs after the wash process; it further enhances the quality of washed and sterilized components by removal of any defective components. The use of components inspected by the ENVISION™ process can decrease the risk of a defective final drug product being administered to a patient, and decrease the risk of drug product shortages by decreasing the number of end-of-line rejects.
For information on visit West’s Envision vision inspection system page or contact West’s Technical Support.
Envision™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions
One factor of parenteral drug product quality is the container closure integrity (CCI) of the primary packaging system. The interaction between the sealing surface of the elastomeric component and the vial is vital to ensure stability of the drug product over the shelf life. Therefore, defects found on the elastomeric component can increase the risk of failure or end-of-the-line rejects.
In today’s manufacturing processes, defects such as loose and embedded foreign matter may cause end of line rejects of drug products—potentially leading to a loss of product or even market recalls. At the same time, regulatory authorities are becoming increasingly more stringent and continually lowering acceptable levels of particulate matter.
Few topics generate as much interest as the reduction of drug manufacturing end-of-line rejects, which is one of the clearest and easiest ways to reduce waste and maximize operating profit and may help improve patient safety. One of the largest contributing factors to the end-of-line reject rate is the quality of the packaging components selected for the drug product.
<em>Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components</em><br />The visual inspection of injectable drug product has been a regulatory requirement since 1936<sup>1</sup>, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero<sup>2</sup>. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.<sup>3</sup> Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”<sup>4</sup>
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 />
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