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The United States Pharmacopeia (USP) continuously creates and revises standards in response to industry needs to keep up with the evolving pharmaceutical landscape. Recently, there has been a surge in revisions of USP chapters centered on the evaluation of packaging components for drug products.<br /><br />
<p>There have been many innovations over the past century since it was first shown that insulin injections could help control chronic diabetes. Advances in hardware and software have resulted in more accurate blood glucose sensors that work via less invasive means and insulin pumps that have become smaller and ever more sophisticated. As we discussed in our <a href="/zh-cn/blog/2017/july/growth-in-glp-1-drugs-may-offer-improved-outcomes-to-people-with-type-ii-diabetes">last blog</a> [1], there are also newer drugs, that when combined with traditional insulin therapy, can help patients better control the blood glucose levels.</p>
West’s Tibor Hlobik and Chris Evans will present at the 2015 Drug Delivery Partnership conference, January 28-30 in Boca Raton, FL.
<p>The right seal is essential for proper drug product vial closure. West offers a wide range of Flip-Off<sup>®</sup> seal (FOS) products to meet customers’ varying requirements. Three grades are available for crimping needs in varying environments:</p><ol><li>Standard Flip-Off<sup>®</sup> seals: for consistent, reliable crimping outside controlled environments</li><li>Flip-Off<sup>®</sup> Plus seals: for clean crimping under grade A air supply</li><li>Flip-Off<sup>®</sup> Clean, Certified, Sterilized (CCS) seals: for aseptic crimping inside grade A environments.</li></ol>
The FDA states: <em>Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* </em>While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
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