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West Analytical Services, LLC continues to invest in the expertise and technology needed to support and partner with customers. This is essential to enable customers to pair new and more complex drug products with the right containment systems, delivery systems and combination products – and navigate the challenging, and ever-changing, regulatory environments. Expansion of the capabilities is focused in four critical areas: (1) extractables and leachables (E&L); (2) container closure integrity (CCI); (3) particle analysis; and (4) testing for packaging, devices and combination products.
In E&L, a new ion mobility quadrupole time of flight mass spectrometer (Q-ToF) has been installed; this enables more precise analyses and identification of unknowns by combining chromatography, ion mobility and mass spectrometry. To address the growing demand for deterministic CCI analysis, a new frequency modulated spectroscopy (oxygen) analyzer has been acquired – enabling non-destructive analysis versus both time and temperature. For particle testing, USP <787>, <788>, <789> and <790> testing is now supported to give customers an understanding of particle levels in finished product. For testing, the capability to conform to critical ISO methods (e.g., 11040-8 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes and 11608-1 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers) has been established – critical to assist customers to properly evaluate performance of container/delivery/combination products.
West’s commitment to customers is clear. We have established expert-level skill in critical areas and industry regulations, as well as state-of-the art testing capabilities to ensure that West is uniquely positioned to partner with customers across the globe to design, execute and interpret studies needed to help drug products and associated packaging and delivery systems move efficiently and safely to patients. For more information visit the Analytical Services pages or contact our Technical Customer Services team.
Put on your mask and suit up as Production Manager, Adam Wrench takes us inside <a href="https://youtu.be/pP7uaialLb0"><span style="text-decoration: underline;">West’s Jersey Shore plant</span></a>. Despite the familiar name, there’s no beach or boardwalk here. Rather, Jersey Shore is a town nestled Pennsylvania’s Allegheny foothills. At this plant, employees create numerous West components, including FluroTec<sup>® </sup>and Teflon<sup>®</sup> laminated 13- and 20mm stoppers. It’s the only West facility that includes two steam sterilizers for Westar<sup>® </sup>RU sterile ready-to-use components.
<p><strong>Date: </strong>February 15-16<br /><strong>Location: </strong>Grande Halle De La Villette – Paris, France<br /><strong>Website: </strong><span style="color: #0000ff;"><a href="http://www.pharmapack.fr/"><span style="text-decoration: underline;">http://www.pharmapack.fr/</span></a></span></p><div><div><div><p><strong>Join West and The Tech Group at Booths 560 and 570!</strong></p></div></div></div>
Coring, fragmentation, and stopper push-in are some of the common issues associated with rubber stoppers used with transfer devices (e.g., vial adapters). This is because they are punctured with spikes, which are significantly larger in diameter than needles, and are made from plastic materials.
West’s Ready Pack™ system with adaptiQ<sup>®</sup> products, that are part of the SCHOTT iQ<sup>®</sup> platform, enables both small and large customers the convenience and flexibility to purchase small quantities of sterile, high-quality, ready-to-use (RTU) components. Ready Pack system components are packaged separately but tested for use as an integrated system. Designed to support customers throughout small-scale R&D, clinical trials, fill-finish evaluation, and commercial-scale manufacturing, the Ready Pack system is a comprehensive, scalable packaging solution that helps customers get to market faster by making the same high-quality packaging available from start to finish. Ready Pack systems keep up with emerging ISO standards and our Ready Pack offering includes the latest glass packaging formats such as adaptiQ<sup>®</sup> clip nest, cup nest, and tray solution.
Sascha Karhöfer, Director Global ICS Platform at West, presented “New Elastomeric Formulation and Relevance of Quality by Design (QbD) in Primary Packaging” on March 19, 2013, at Pharma-Kongress: Production and Technique in Dusseldorf, Germany.
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