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Experimental characterization of an elastomer plunger in a particular pre-filled syringe system is essential to help pharmaceutical manufacturers determine whether that plunger is suitable for intended use. The strategy for a characterization study must consider relevant factors, in particular, compatibility with drug product and the ability to enable consistent delivery of drug product (dosage and time), by a clinician or by an autoinjector.
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.
<span style="color: #333333;">Earlier this month, <a href="/pt-pt/services/contract-manufacturing">West's contract manufacturing team</a>—formerly known as <span style="color: #000000;">The Tech Group</span>, officially received its Engineering and Production Technology Leadership award at the Frost & Sullivan Manufacturing Leadership Awards Gala in Carlsbad, California. Winners in this category were honored for embracing new design and production approaches to drive game-changing process improvements. </span>
<em>Many West customers have encountered the challenge of manufacturing sensitive injectables at older sites. <strong>Herman Bozenhardt</strong> consults and lectures on aging facilities and is the President at Bozenhardt Consulting Services LLC. We caught up with him to find out more.</em>
With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
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