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Selecting the best vial container closure system (CCS) components and capping process for a drug product ensures optimal performance and patient safety. An optimized CCS requires compatible components (rubber stopper, aluminum seal, glass or polymer vial) and proper capping setup. This provides predictable sealing performance, which maintains the container closure integrity (CCI) needed for patient safety and visual acceptance.
Components and capping setup must be considered together in order to define a robust and optimal performance window for the CCS. Piece-to-piece variations in each of the three CCS components present a challenge. Variations within component dimensional tolerances can have drastic effects on the expected amount of rubber compression, as well as the resulting seal skirt overhang length.
This was discussed by A. Bucci and Q. Zeng in Comprehensive Container Closure System Stack-Up Simulation and Optimization in the Digital Age at 2019 PDA Europe Parenteral Packaging Conference. It was shown that by applying a comprehensive stack-up analysis, using both manufacturing data and laboratory testing, it is possible to calculate the configurations of every assembled and compressed CCS. This information is then overlaid onto the performance window to predict the probability of outliers which may cause CCS defects. Using this information, drug product manufacturers can properly select CCS components and tune the capping process to ensure predictable and reliable sealing performance. This helps to ensure drug product performance and safety.
For more on how West can help select and use CCS components, contact an Account Manager or Technical Customer Service (TCS) representative.
<em>As we continue the 10<sup>th</sup> Anniversary of the West without Borders fundraising campaign, let’s take a look back at what the partnership with Camp Victory. The partnership has existed formally for West since 2007 when “Uncle Walt’s Treehouse” was built thanks to donations from West team members, and informally for many volunteers long before that, has meant to team members from the Jersey Shore and Williamsport plants.</em>
Our culture is based on supporting the health and well-being of our communities. Now more than ever, it’s important to reach out and help those in need. To support our communities around the world, West is donating to multiple organizations that are making important contributions to society and need support during the COVID-19 pandemic.
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted.<span> </span>This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them.<span> </span>Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (<em>Elastomeric Closure for Injections</em>) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: <em>Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems</em>).<span> </span><p> </p>
<em>The following is an excerpt of an article that appears in the Summer 2014 edition (Vol. 6, Issue 2) of International Pharmaceutical Industry magazine. To read the complete article, which begins on page 92 of the issue, visit: </em><a href="http://issuu.com/mark123/docs/ipi_-_volume_6_issue_2_june_2014"><span style="text-decoration: underline;">http://issuu.com/mark123/docs/ipi_-_volume_6_issue_2_june_2014</span></a>
In addition to enabling some of the traditional processes that IT is called upon to support, West IT has been given the opportunity to support West’s global knowledge management initiative. Our colleagues in Quality Assurance and Research and Development have enlisted IT to assist in the enablement of our Knowledge Management strategy.
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