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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.
The defect categories can range from critical (e.g., impacting CCI) to minor (e.g., impacting cosmetic appearance). Root causes of defects may occur from various steps in the manufacturing process, such as non-fills/voids from the molding process, or loose elastomeric material from the trimming process. To reduce the occurrence of defects, components can be evaluated via West’s Envision™ verification system, an automated 100% vision verification system. Each component is passed through several cameras inspecting for defects. Components that do not meet the criteria for release are removed from the batch, elevating the quality of the finished goods. For vial stoppers, and cartridge or pre-filled syringe plungers, West’s Envision system is validated for various designs and formulations.
Additionally, since the Envision process is performed after the pharmaceutical wash process (e.g., West's Westar® process), there is no impact to the Drug Master File (DMF). The Envision process can be implemented at any phase of the drug product lifecycle. Implementing the Envision process on elastomeric components can reduce the risk of failure and improve drug product quality.
For more on how West can provide support, please contact your Account Manager or Technical Account Specialist.
Envision™ and Westar® are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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.
<p><span>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.</span></p>
Spotting a quality issue on a stopper or plunger can be difficult. While a trimming or molding defect may be noticeable, embedded particulate or foreign contamination may be far too small for the human eye to see. <br />
As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
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